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NCT01177397 · STUDY IN CONTEXT

Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

A dose-limiting toxicity was defined as: - ≥ Grade 3 (per Common Terminology Criteria for Adverse Events \[CTCAE\] Version 4) clinically relevant adverse event (AE) or laboratory abnormality suspected to be related to CC-223 that commenced within 30 days of first dose, except alopecia, Grade 3 rash of the acneiform or maculopapular type for \< 5 days, Grade 3 diarrhea or vomiting lasting \< 72 hours, repeated occurrence of Grade 3 hyperuricaemia in subjects with Grade 3 hyperuricemia at baseline, hyperglycemia, hematologic and liver function test (LFT) abnormalities due to disease progression. - Grade 2 fasting hyperglycemia lasting \> 14 days or ≥ Grade 3 lasting \> 4 days despite optimal medical treatment. - Hematological toxicities including febrile neutropenia, Grade 4 neutropenia or thrombocytopenia for \> 7 days, or Grade 3/4 thrombocytopenia with clinically significant bleeding. - Grade 4 LTFs - AE suspected to be CC-223 related necessitating dose reduction during cycle 1.

All treated participants in Part A.

primary · POSTED

Cmax is defined as the maximum observed concentration (in plasma), obtained directly from the observed concentration versus time data. Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.

All treated participants with available pharmacokinetic data in Part A.

primary · POSTED

Tmax is defined as the time to Cmax, obtained directly from the observed concentration versus time data. Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.

All treated participants with available pharmacokinetic data in Part A.

primary · POSTED

Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.

All treated participants with available pharmacokinetic data in Part A.

primary · POSTED

AUC0-24 is defined as the area under the concentration-time curve from Time 0 to 24 hours after a dose. Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.

All treated participants with available pharmacokinetic data in Part A.

primary · POSTED

AUCinf is defined as the area under the concentration-time curve from Time 0 extrapolated to infinity. Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. AUCinf was not assessed following multiple dosing as the blood sampling schedule on Day 15 did not allow robust assessment of the terminal elimination rate constant.

All treated participants with available pharmacokinetic data in Part A.

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-liver-neoplasm
nct id: NCT01177397
trial label: Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 12
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
outcome key
om-0000
source section id
NCT01177397-om-0000
source outcome index
0
endpoint
Part A: Number of Participants With Dose-limiting Toxicities
endpoint definition
A dose-limiting toxicity was defined as: - ≥ Grade 3 (per Common Terminology Criteria for Adverse Events \[CTCAE\] Version 4) clinically relevant adverse event (AE) or laboratory abnormality suspected to be related to CC-223 that commenced within 30 days of first dose, except alopecia, Grade 3 rash of the acneiform or maculopapular type for \< 5 days, Grade 3 diarrhea or vomiting lasting \< 72 hours, repeated occurrence of Grade 3 hyperuricaemia in subjects with Grade 3 hyperuricemia at baseline, hyperglycemia, hematologic and liver function test (LFT) abnormalities due to disease progression. - Grade 2 fasting hyperglycemia lasting \> 14 days or ≥ Grade 3 lasting \> 4 days despite optimal medical treatment. - Hematological toxicities including febrile neutropenia, Grade 4 neutropenia or thrombocytopenia for \> 7 days, or Grade 3/4 thrombocytopenia with clinically significant bleeding. - Grade 4 LTFs - AE suspected to be CC-223 related necessitating dose reduction during cycle 1.
time origin
From first dose up to 30 days after first dose
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All treated participants in Part A.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
outcome key
om-0001
source section id
NCT01177397-om-0001
source outcome index
1
endpoint
Maximum Observed Plasma Concentration (Cmax) of CC-223
endpoint definition
Cmax is defined as the maximum observed concentration (in plasma), obtained directly from the observed concentration versus time data. Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
time origin
Cycle 1 Day 1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All treated participants with available pharmacokinetic data in Part A.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
outcome key
om-0002
source section id
NCT01177397-om-0002
source outcome index
2
endpoint
Time to Maximum Concentration (Tmax) of CC-223
endpoint definition
Tmax is defined as the time to Cmax, obtained directly from the observed concentration versus time data. Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
time origin
Cycle 1 Day 1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All treated participants with available pharmacokinetic data in Part A.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
outcome key
om-0003
source section id
NCT01177397-om-0003
source outcome index
3
endpoint
Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) for CC-223
endpoint definition
Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
time origin
Cycle 1 Day -1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All treated participants with available pharmacokinetic data in Part A.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
outcome key
om-0004
source section id
NCT01177397-om-0004
source outcome index
4
endpoint
Area Under the Concentration Time-Curve From 0-24 Hours After a Dose (AUC0-24) for CC-223
endpoint definition
AUC0-24 is defined as the area under the concentration-time curve from Time 0 to 24 hours after a dose. Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL.
time origin
0 to 24 hours post-dose on Day -1 and Day 15
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All treated participants with available pharmacokinetic data in Part A.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
outcome key
om-0005
source section id
NCT01177397-om-0005
source outcome index
5
endpoint
Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) For CC-223
endpoint definition
AUCinf is defined as the area under the concentration-time curve from Time 0 extrapolated to infinity. Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. AUCinf was not assessed following multiple dosing as the blood sampling schedule on Day 15 did not allow robust assessment of the terminal elimination rate constant.
time origin
Cycle 1 Day 1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose and Day 15: pre-dose, 0.5, 1, 1.5, 3, 5, and 8 hours post-dose
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All treated participants with available pharmacokinetic data in Part A.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
outcome key
om-0000
arm key
OG000
arm label
Part A: CC-223 7.5 mg
regimen
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01177397-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
outcome key
om-0000
arm key
OG001
arm label
Part A: CC-223 15 mg
regimen
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01177397-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
outcome key
om-0000
arm key
OG002
arm label
Part A: CC-223 30 mg
regimen
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01177397-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
outcome key
om-0000
arm key
OG003
arm label
Part A: CC-223 45 mg
regimen
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01177397-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
outcome key
om-0000
arm key
OG004
arm label
Part A: CC-223 60 mg
regimen
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01177397-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
outcome key
om-0001
arm key
OG000
arm label
Part A: CC-223 7.5 mg
regimen
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01177397-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
outcome key
om-0001
arm key
OG001
arm label
Part A: CC-223 15 mg
regimen
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01177397-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
outcome key
om-0001
arm key
OG002
arm label
Part A: CC-223 30 mg
regimen
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01177397-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
outcome key
om-0001
arm key
OG003
arm label
Part A: CC-223 45 mg
regimen
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01177397-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
outcome key
om-0001
arm key
OG004
arm label
Part A: CC-223 60 mg
regimen
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01177397-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
outcome key
om-0002
arm key
OG000
arm label
Part A: CC-223 7.5 mg
regimen
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01177397-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
outcome key
om-0002
arm key
OG001
arm label
Part A: CC-223 15 mg
regimen
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01177397-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
harm key
EG000
source section id
NCT01177397-ae
event group key
EG000
event group label
Part A: CC-223 7.5 mg
serious affected
0
serious at risk
1
other affected
1
other at risk
1
frequency threshold
5
collection period
All-Cause Mortality: From first dose through the course of the trial (up to approximately 6 years). Part A SAEs and AEs: From first dose to 100 days post last dose (up to approximately 14 months). Part B SAEs and AEs: From first dose to 100 days post last dose (up to approximately 49 months).
event definition
Although the protocol stated Part B participants would begin treatment at the MTD determined by Part A (45 mg), the conduct of Part B permitted participants to stay in the study even though they had many dose reductions and dosing interruptions. Dosing/exposure for participants varied greatly and there were few participants which remained at any given dose for most of the study. Due to this, there was no analysis of Part B data available according to dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
harm key
EG001
source section id
NCT01177397-ae
event group key
EG001
event group label
Part A: CC-223 15 mg
serious affected
0
serious at risk
2
other affected
2
other at risk
2
frequency threshold
5
collection period
All-Cause Mortality: From first dose through the course of the trial (up to approximately 6 years). Part A SAEs and AEs: From first dose to 100 days post last dose (up to approximately 14 months). Part B SAEs and AEs: From first dose to 100 days post last dose (up to approximately 49 months).
event definition
Although the protocol stated Part B participants would begin treatment at the MTD determined by Part A (45 mg), the conduct of Part B permitted participants to stay in the study even though they had many dose reductions and dosing interruptions. Dosing/exposure for participants varied greatly and there were few participants which remained at any given dose for most of the study. Due to this, there was no analysis of Part B data available according to dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
harm key
EG002
source section id
NCT01177397-ae
event group key
EG002
event group label
Part A: CC-223 30 mg
serious affected
4
serious at risk
9
other affected
8
other at risk
9
frequency threshold
5
collection period
All-Cause Mortality: From first dose through the course of the trial (up to approximately 6 years). Part A SAEs and AEs: From first dose to 100 days post last dose (up to approximately 14 months). Part B SAEs and AEs: From first dose to 100 days post last dose (up to approximately 49 months).
event definition
Although the protocol stated Part B participants would begin treatment at the MTD determined by Part A (45 mg), the conduct of Part B permitted participants to stay in the study even though they had many dose reductions and dosing interruptions. Dosing/exposure for participants varied greatly and there were few participants which remained at any given dose for most of the study. Due to this, there was no analysis of Part B data available according to dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
harm key
EG003
source section id
NCT01177397-ae
event group key
EG003
event group label
Part A: CC-223 45 mg
serious affected
4
serious at risk
9
other affected
9
other at risk
9
frequency threshold
5
collection period
All-Cause Mortality: From first dose through the course of the trial (up to approximately 6 years). Part A SAEs and AEs: From first dose to 100 days post last dose (up to approximately 14 months). Part B SAEs and AEs: From first dose to 100 days post last dose (up to approximately 49 months).
event definition
Although the protocol stated Part B participants would begin treatment at the MTD determined by Part A (45 mg), the conduct of Part B permitted participants to stay in the study even though they had many dose reductions and dosing interruptions. Dosing/exposure for participants varied greatly and there were few participants which remained at any given dose for most of the study. Due to this, there was no analysis of Part B data available according to dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
harm key
EG004
source section id
NCT01177397-ae
event group key
EG004
event group label
Part A: CC-223 60 mg
serious affected
2
serious at risk
7
other affected
7
other at risk
7
frequency threshold
5
collection period
All-Cause Mortality: From first dose through the course of the trial (up to approximately 6 years). Part A SAEs and AEs: From first dose to 100 days post last dose (up to approximately 14 months). Part B SAEs and AEs: From first dose to 100 days post last dose (up to approximately 49 months).
event definition
Although the protocol stated Part B participants would begin treatment at the MTD determined by Part A (45 mg), the conduct of Part B permitted participants to stay in the study even though they had many dose reductions and dosing interruptions. Dosing/exposure for participants varied greatly and there were few participants which remained at any given dose for most of the study. Due to this, there was no analysis of Part B data available according to dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
harm key
EG005
source section id
NCT01177397-ae
event group key
EG005
event group label
Part B: Non-small Cell Lung Cancer (NSCLC)
serious affected
15
serious at risk
26
other affected
26
other at risk
26
frequency threshold
5
collection period
All-Cause Mortality: From first dose through the course of the trial (up to approximately 6 years). Part A SAEs and AEs: From first dose to 100 days post last dose (up to approximately 14 months). Part B SAEs and AEs: From first dose to 100 days post last dose (up to approximately 49 months).
event definition
Although the protocol stated Part B participants would begin treatment at the MTD determined by Part A (45 mg), the conduct of Part B permitted participants to stay in the study even though they had many dose reductions and dosing interruptions. Dosing/exposure for participants varied greatly and there were few participants which remained at any given dose for most of the study. Due to this, there was no analysis of Part B data available according to dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
harm key
EG006
source section id
NCT01177397-ae
event group key
EG006
event group label
Part B: Glioblastoma Multiforme (GBM)
serious affected
6
serious at risk
13
other affected
13
other at risk
13
frequency threshold
5
collection period
All-Cause Mortality: From first dose through the course of the trial (up to approximately 6 years). Part A SAEs and AEs: From first dose to 100 days post last dose (up to approximately 14 months). Part B SAEs and AEs: From first dose to 100 days post last dose (up to approximately 49 months).
event definition
Although the protocol stated Part B participants would begin treatment at the MTD determined by Part A (45 mg), the conduct of Part B permitted participants to stay in the study even though they had many dose reductions and dosing interruptions. Dosing/exposure for participants varied greatly and there were few participants which remained at any given dose for most of the study. Due to this, there was no analysis of Part B data available according to dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
harm key
EG007
source section id
NCT01177397-ae
event group key
EG007
event group label
Part B: Hepatocellular Carcinoma (HCC)
serious affected
29
serious at risk
53
other affected
53
other at risk
53
frequency threshold
5
collection period
All-Cause Mortality: From first dose through the course of the trial (up to approximately 6 years). Part A SAEs and AEs: From first dose to 100 days post last dose (up to approximately 14 months). Part B SAEs and AEs: From first dose to 100 days post last dose (up to approximately 49 months).
event definition
Although the protocol stated Part B participants would begin treatment at the MTD determined by Part A (45 mg), the conduct of Part B permitted participants to stay in the study even though they had many dose reductions and dosing interruptions. Dosing/exposure for participants varied greatly and there were few participants which remained at any given dose for most of the study. Due to this, there was no analysis of Part B data available according to dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
harm key
EG008
source section id
NCT01177397-ae
event group key
EG008
event group label
Part B: Neuroendocrine Tumor (NET)
serious affected
23
serious at risk
47
other affected
47
other at risk
47
frequency threshold
5
collection period
All-Cause Mortality: From first dose through the course of the trial (up to approximately 6 years). Part A SAEs and AEs: From first dose to 100 days post last dose (up to approximately 14 months). Part B SAEs and AEs: From first dose to 100 days post last dose (up to approximately 49 months).
event definition
Although the protocol stated Part B participants would begin treatment at the MTD determined by Part A (45 mg), the conduct of Part B permitted participants to stay in the study even though they had many dose reductions and dosing interruptions. Dosing/exposure for participants varied greatly and there were few participants which remained at any given dose for most of the study. Due to this, there was no analysis of Part B data available according to dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
harm key
EG009
source section id
NCT01177397-ae
event group key
EG009
event group label
Part B: Diffuse Large B-cell Lymphoma (DLBCL)
serious affected
17
serious at risk
28
other affected
28
other at risk
28
frequency threshold
5
collection period
All-Cause Mortality: From first dose through the course of the trial (up to approximately 6 years). Part A SAEs and AEs: From first dose to 100 days post last dose (up to approximately 14 months). Part B SAEs and AEs: From first dose to 100 days post last dose (up to approximately 49 months).
event definition
Although the protocol stated Part B participants would begin treatment at the MTD determined by Part A (45 mg), the conduct of Part B permitted participants to stay in the study even though they had many dose reductions and dosing interruptions. Dosing/exposure for participants varied greatly and there were few participants which remained at any given dose for most of the study. Due to this, there was no analysis of Part B data available according to dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
harm key
EG010
source section id
NCT01177397-ae
event group key
EG010
event group label
Part B: Multiple Myeloma (MM)
serious affected
6
serious at risk
14
other affected
14
other at risk
14
frequency threshold
5
collection period
All-Cause Mortality: From first dose through the course of the trial (up to approximately 6 years). Part A SAEs and AEs: From first dose to 100 days post last dose (up to approximately 14 months). Part B SAEs and AEs: From first dose to 100 days post last dose (up to approximately 49 months).
event definition
Although the protocol stated Part B participants would begin treatment at the MTD determined by Part A (45 mg), the conduct of Part B permitted participants to stay in the study even though they had many dose reductions and dosing interruptions. Dosing/exposure for participants varied greatly and there were few participants which remained at any given dose for most of the study. Due to this, there was no analysis of Part B data available according to dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01177397
harm key
EG011
source section id
NCT01177397-ae
event group key
EG011
event group label
Part B: Hormone Receptor Positive Breast Cancer (HRPBC)
serious affected
11
serious at risk
17
other affected
17
other at risk
17
frequency threshold
5
collection period
All-Cause Mortality: From first dose through the course of the trial (up to approximately 6 years). Part A SAEs and AEs: From first dose to 100 days post last dose (up to approximately 14 months). Part B SAEs and AEs: From first dose to 100 days post last dose (up to approximately 49 months).
event definition
Although the protocol stated Part B participants would begin treatment at the MTD determined by Part A (45 mg), the conduct of Part B permitted participants to stay in the study even though they had many dose reductions and dosing interruptions. Dosing/exposure for participants varied greatly and there were few participants which remained at any given dose for most of the study. Due to this, there was no analysis of Part B data available according to dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

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