NCT00939770 · OUTCOME

Number of Participants (Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma (ALCL))With Response to Crizotinib

Crizotinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma · Source last updated 2020-06-09

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Up to 8 years

What was measured

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Analysis population: Part A Participants with relapsed or refractory solid tumors or anaplastic large cell lymphoma (ALCL)

Groups in this outcome

Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID

Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.

Phase 1: Part A: PF-02341066 130 mg/m²/Dose BID

Phase 1: Part A: PF-02341066 165 mg/m²/Dose BID

Phase 1: Part A: PF-02341066 215 mg/m²/Dose BID

Phase 1: Part A: PF-02341066 280 mg/m2/Dose BID

Phase 1: Part A: PF-02341066 365 mg/m2/Dose BID

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID	6
Phase 1: Part A: PF-02341066 130 mg/m²/Dose BID	8
Phase 1: Part A: PF-02341066 165 mg/m²/Dose BID	23
Phase 1: Part A: PF-02341066 215 mg/m²/Dose BID	12
Phase 1: Part A: PF-02341066 280 mg/m2/Dose BID	38
Phase 1: Part A: PF-02341066 365 mg/m2/Dose BID	11

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID	0	Not reported	Not reported	Not reported	Not reported
Phase 1: Part A: PF-02341066 130 mg/m²/Dose BID	0	Not reported	Not reported	Not reported	Not reported
Phase 1: Part A: PF-02341066 165 mg/m²/Dose BID	7	Not reported	Not reported	Not reported	Not reported
Phase 1: Part A: PF-02341066 215 mg/m²/Dose BID	0	Not reported	Not reported	Not reported	Not reported
Phase 1: Part A: PF-02341066 280 mg/m2/Dose BID	19	Not reported	Not reported	Not reported	Not reported
Phase 1: Part A: PF-02341066 365 mg/m2/Dose BID	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
7
group Id
OG003
value
0
group Id
OG004
value
19
group Id
OG005
value
1

denoms

counts
group Id
OG000
value
6
group Id
OG001
value
8
group Id
OG002
value
23
group Id
OG003
value
12
group Id
OG004
value
38
group Id
OG005
value
11
units
Participants

description

groups

description
Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
id
OG000
title
Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID
description
Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
id
OG001
title
Phase 1: Part A: PF-02341066 130 mg/m²/Dose BID
description
Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
id
OG002
title
Phase 1: Part A: PF-02341066 165 mg/m²/Dose BID
description
Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
id
OG003
title
Phase 1: Part A: PF-02341066 215 mg/m²/Dose BID
description
Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
id
OG004
title
Phase 1: Part A: PF-02341066 280 mg/m2/Dose BID
description
Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
id
OG005
title
Phase 1: Part A: PF-02341066 365 mg/m2/Dose BID

param Type

COUNT_OF_PARTICIPANTS

population Description

Part A Participants with relapsed or refractory solid tumors or anaplastic large cell lymphoma (ALCL)

reporting Status

POSTED

time Frame

Up to 8 years

title

Number of Participants (Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma (ALCL))With Response to Crizotinib

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice