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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: unclear. Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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-non-small-cell-lung-cancer-locally-advanced-c478f41c
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
unclear
applicability note
Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-locally-advanced-c478f41c
    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
quality of life
    setting source links

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