NCT01606878 · ADVERSE EVENTS

Adverse events

Crizotinib and Combination Chemotherapy in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma · Source last updated 2024-01-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Up to 2 years
Other-event reporting threshold: 0%

Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part A Dose Level 1 Patients receive 165 mg/m\^2 crizotinib (oral solution) PO BID on days 1-21, 250 mg/m\^2 cyclophosphamide IV QD on days 1-5, and topotecan hydrochloride IV QD on days 1-5. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)	3 / 6	6 / 6	0 / 6
Part A Dose Level 2 Patients receive 215 mg/m\^2 crizotinib (oral solution) PO BID on days 1-21, 250 mg/m\^2 cyclophosphamide IV QD on days 1-5, and topotecan hydrochloride IV QD on days 1-5. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)	3 / 4	4 / 4	0 / 4
Part B Dose Level 1 Patients receive 165 mg/m\^2 crizotinib (oral solution) PO BID as in Part A. Patients also receive 1.5 mg/m\^2 vincristine sulfate IV on day 1, 450 mg/m\^2 dexrazoxane hydrochloride IV on day 1, and 45 mg/m\^2 doxorubicin hydrochloride IV over 15 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)	1 / 5	5 / 5	1 / 5
Part B Dose Level 2 Patients receive 215 mg/m\^2 crizotinib (oral solution) PO BID as in Part A. Patients also receive 1.5 mg/m\^2 vincristine sulfate IV on day 1, 450 mg/m\^2 dexrazoxane hydrochloride IV on day 1, and 45 mg/m\^2 doxorubicin hydrochloride IV over 15 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)	1 / 3	3 / 3	0 / 3
Part B Dose Level 3 Patients receive 280 mg/m\^2 crizotinib (oral solution) PO BID as in Part A. Patients also receive 1.5 mg/m\^2 vincristine sulfate IV on day 1, 450 mg/m\^2 dexrazoxane hydrochloride IV on day 1, and 45 mg/m\^2 doxorubicin hydrochloride IV over 15 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)	2 / 3	3 / 3	0 / 3
Part C Dose Level 1 Patients receive 165 mg/m\^2 crizotinib (capsule formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.	3 / 4	4 / 4	1 / 4
Part C Dose Level 2 Patients receive 215 mg/m\^2 crizotinib (capsule formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.	3 / 6	6 / 6	0 / 6
Part C Dose Level 3 Patients receive 280 mg/m\^2 crizotinib (capsule formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.	1 / 3	3 / 3	0 / 3
Part D Dose Level 1 Patients receive 165 mg/m\^2 crizotinib (microsphere formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.	3 / 6	6 / 6	0 / 6
Part D Dose Level 2 Patients receive 215 mg/m\^2 crizotinib (microsphere formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.	3 / 3	3 / 3	0 / 3
Part PK Dose Level 2 Patients receive 215 mg/m\^2 crizotinib (microsphere formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.	2 / 3	3 / 3	0 / 3

Group identifiers: EG000: Part A Dose Level 1 · EG001: Part A Dose Level 2 · EG002: Part B Dose Level 1 · EG003: Part B Dose Level 2 · EG004: Part B Dose Level 3 · EG005: Part C Dose Level 1 · EG006: Part C Dose Level 2 · EG007: Part C Dose Level 3 · EG008: Part D Dose Level 1 · EG009: Part D Dose Level 2 · EG010: Part PK Dose Level 2

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Acidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
1
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Depressed level of consciousness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
1
num At Risk
3
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Dyspnea

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
2
num At Risk
5
group Id
EG003
num Affected
2
num At Risk
3
group Id
EG004
num Affected
2
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
4
group Id
EG006
num Affected
4
num At Risk
6
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
4
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Acidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
2
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
1
num At Risk
3
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
4
group Id
EG002
num Affected
4
num At Risk
5
group Id
EG003
num Affected
3
num At Risk
3
group Id
EG004
num Affected
3
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
5
num At Risk
6
group Id
EG007
num Affected
2
num At Risk
3
group Id
EG008
num Affected
6
num At Risk
6
group Id
EG009
num Affected
2
num At Risk
3
group Id
EG010
num Affected
2
num At Risk
3
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
2
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
4
group Id
EG006
num Affected
3
num At Risk
6
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
1
num At Risk
3
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Alkalosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Allergic rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
3
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
4
group Id
EG002
num Affected
3
num At Risk
5
group Id
EG003
num Affected
3
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
4
num At Risk
4
group Id
EG006
num Affected
6
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
3
num At Risk
6
group Id
EG009
num Affected
2
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Alopecia

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
6
description
Patients receive 165 mg/m\^2 crizotinib (oral solution) PO BID on days 1-21, 250 mg/m\^2 cyclophosphamide IV QD on days 1-5, and topotecan hydrochloride IV QD on days 1-5. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)
id
EG000
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Part A Dose Level 1
deaths Num Affected
0
deaths Num At Risk
4
description
Patients receive 215 mg/m\^2 crizotinib (oral solution) PO BID on days 1-21, 250 mg/m\^2 cyclophosphamide IV QD on days 1-5, and topotecan hydrochloride IV QD on days 1-5. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)
id
EG001
other Num Affected
4
other Num At Risk
4
serious Num Affected
3
serious Num At Risk
4
title
Part A Dose Level 2
deaths Num Affected
1
deaths Num At Risk
5
description
Patients receive 165 mg/m\^2 crizotinib (oral solution) PO BID as in Part A. Patients also receive 1.5 mg/m\^2 vincristine sulfate IV on day 1, 450 mg/m\^2 dexrazoxane hydrochloride IV on day 1, and 45 mg/m\^2 doxorubicin hydrochloride IV over 15 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)
id
EG002
other Num Affected
5
other Num At Risk
5
serious Num Affected
1
serious Num At Risk
5
title
Part B Dose Level 1
deaths Num Affected
0
deaths Num At Risk
3
description
Patients receive 215 mg/m\^2 crizotinib (oral solution) PO BID as in Part A. Patients also receive 1.5 mg/m\^2 vincristine sulfate IV on day 1, 450 mg/m\^2 dexrazoxane hydrochloride IV on day 1, and 45 mg/m\^2 doxorubicin hydrochloride IV over 15 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)
id
EG003
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Part B Dose Level 2
deaths Num Affected
0
deaths Num At Risk
3
description
Patients receive 280 mg/m\^2 crizotinib (oral solution) PO BID as in Part A. Patients also receive 1.5 mg/m\^2 vincristine sulfate IV on day 1, 450 mg/m\^2 dexrazoxane hydrochloride IV on day 1, and 45 mg/m\^2 doxorubicin hydrochloride IV over 15 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)
id
EG004
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Part B Dose Level 3
deaths Num Affected
1
deaths Num At Risk
4
description
Patients receive 165 mg/m\^2 crizotinib (capsule formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
id
EG005
other Num Affected
4
other Num At Risk
4
serious Num Affected
3
serious Num At Risk
4
title
Part C Dose Level 1
deaths Num Affected
0
deaths Num At Risk
6
description
Patients receive 215 mg/m\^2 crizotinib (capsule formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
id
EG006
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Part C Dose Level 2
deaths Num Affected
0
deaths Num At Risk
3
description
Patients receive 280 mg/m\^2 crizotinib (capsule formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
id
EG007
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Part C Dose Level 3
deaths Num Affected
0
deaths Num At Risk
6
description
Patients receive 165 mg/m\^2 crizotinib (microsphere formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
id
EG008
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Part D Dose Level 1
deaths Num Affected
0
deaths Num At Risk
3
description
Patients receive 215 mg/m\^2 crizotinib (microsphere formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
id
EG009
other Num Affected
3
other Num At Risk
3
serious Num Affected
3
serious Num At Risk
3
title
Part D Dose Level 2
deaths Num Affected
0
deaths Num At Risk
3
description
Patients receive 215 mg/m\^2 crizotinib (microsphere formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
id
EG010
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Part PK Dose Level 2

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
2
num At Risk
5
group Id
EG003
num Affected
2
num At Risk
3
group Id
EG004
num Affected
2
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
4
group Id
EG006
num Affected
4
num At Risk
6
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
4
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Acidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
2
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
1
num At Risk
3
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
4
group Id
EG002
num Affected
4
num At Risk
5
group Id
EG003
num Affected
3
num At Risk
3
group Id
EG004
num Affected
3
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
5
num At Risk
6
group Id
EG007
num Affected
2
num At Risk
3
group Id
EG008
num Affected
6
num At Risk
6
group Id
EG009
num Affected
2
num At Risk
3
group Id
EG010
num Affected
2
num At Risk
3
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
2
num At Risk
3
group Id
EG005
num Affected
2
num At Risk
4
group Id
EG006
num Affected
3
num At Risk
6
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
1
num At Risk
3
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Alkalosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
1
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Allergic rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
3
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
4
group Id
EG002
num Affected
3
num At Risk
5
group Id
EG003
num Affected
3
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
4
num At Risk
4
group Id
EG006
num Affected
6
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
3
num At Risk
6
group Id
EG009
num Affected
2
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Alopecia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Acidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
1
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Depressed level of consciousness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
3
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
1
num At Risk
3
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
3
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
6
group Id
EG009
num Affected
0
num At Risk
3
group Id
EG010
num Affected
0
num At Risk
3
term
Dyspnea

time Frame

Up to 2 years

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice