A Safety and Efficacy Study of CC-90011 in Participants W... | NCT02875223 | Trialant
NCT02875223
Sponsor
Celgene
Status
Terminated
Last Update Posted
Apr 20, 2025Actual
Enrollment
75Actual
Phase
Phase 1
Conditions
Lymphoma, Non-Hodgkin
Neoplasms
Interventions
CC-90011
Rifampicin
Itraconazole
Countries
France
Italy
Japan
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02875223
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CC-90011-ST-001
Secondary IDs
Not provided
Brief Title
A Safety and Efficacy Study of CC-90011 in Participants With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas
Official Title
A Phase 1, Open-label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CC-90011 in Subjects With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas
Acronym
Not provided
Organization
CelgeneINDUSTRY
Status Module
Record Verification Date
Apr 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Business objectives have changed
Expanded Access Info
No
Start Date
Aug 31, 2016Actual
Primary Completion Date
Mar 25, 2024Actual
Completion Date
Mar 25, 2024Actual
First Submitted Date
Aug 18, 2016
First Submission Date that Met QC Criteria
Aug 18, 2016
First Posted Date
Aug 23, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 21, 2025
Results First Submitted that Met QC Criteria
Apr 18, 2025
Results First Posted Date
Apr 20, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 18, 2025
Last Update Posted Date
Apr 20, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
CelgeneINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Study CC-90011-ST-001 is an open-label, Phase 1, dose escalation and expansion, First-In-Human (FIH) clinical study of CC-90011 in subjects with advanced unresectable solid tumors (enriched for grade 2 NENs, grade 2 NETs and NECs) and R/R NHL (MZL, including extranodal MZL [EMZL], splenic MZL [SMZL], nodal MZL [NMZL], and histologic transformation of MZL). The dose escalation part (Part A) of the study will explore escalating oral doses of CC-90011 to estimate the maximum tolerated dose (MTD) of CC-90011. The expansion part (Part B) will further evaluate the safety and efficacy of CC-90011 administered at or below the MTD in 3 selected expansion cohorts of approximately 10-20 evaluable subjects each, in order to further define the RP2D.
Detailed Description
Not provided
Conditions Module
Conditions
Lymphoma, Non-Hodgkin
Neoplasms
Keywords
Safety
CC-90011
Advanced unresectable solid Tumors
Low intermediate-grade lung neuroendocrine tumors (Typical and Atypical carcinoids)
Neuroendocrine prostate cancer (NEPC)
R/R Non-Hodgkin's Lymphomas
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
75Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
CC-90011 and Rifampicin
Experimental
Drug: CC-90011
Drug: Rifampicin
CC-90011 and Itraconazole
Experimental
Drug: CC-90011
Drug: Itraconazole
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CC-90011
Drug
Specified dose on specified days
CC-90011 and Itraconazole
CC-90011 and Rifampicin
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part A - Number of Participants With Dose Limiting Toxicities (DLTs)
Dose-limiting toxicities (DLTs) during dose escalation are defined as follows, occurring within the Cycle 1 (28 days) DLT assessment period, unless clearly unrelated to CC-90011: Any Grade 4 non-hematologic toxicity; any non-hematologic toxicity Grade ≥ 3 except Grade 3 diarrhea, nausea, or vomiting of ≤ 3 days duration, Grade 3 rash resolving to Grade ≤ 2 within 7 days without recurrence, and Grade 3 fatigue resolving to Grade ≤ 2 within 7 days without recurrence. Hematological toxicities include febrile neutropenia, Grade 4 neutropenia > 7 days, Grade 4 thrombocytopenia > 7 days, or Grade ≥ 3 thrombocytopenia with significant bleeding. Any AE necessitating dose reduction during Cycle 1, or any other toxicity deemed dose-limiting by the safety committee. The MTD is the highest dose at which less than 33% of the population treated with CC-90011 suffer a DLT in the first cycle and at least 6 evaluable participants have been treated at this dose.
Cycle 1 (Each cycle is of 28 days)
Part A - Maximum Tolerated Dose (MTDs)
The MTD is the highest dose at which less than 33% of the population treated with CC-90011 suffer a DLT in the first cycle and at least 6 evaluable participants have been treated at this dose. Dose-limiting toxicities (DLTs) during dose escalation are defined as follows, occurring within the Cycle 1 (28 days) DLT assessment period, unless clearly unrelated to CC-90011: Any Grade 4 non-hematologic toxicity; any non-hematologic toxicity Grade ≥ 3 except Grade 3 diarrhea, nausea, or vomiting of ≤ 3 days duration, Grade 3 rash resolving to Grade ≤ 2 within 7 days without recurrence, and Grade 3 fatigue resolving to Grade ≤ 2 within 7 days without recurrence. Hematological toxicities include febrile neutropenia, Grade 4 neutropenia > 7 days, Grade 4 thrombocytopenia > 7 days, or Grade ≥ 3 thrombocytopenia with significant bleeding. Any AE necessitating dose reduction during Cycle 1, or any other toxicity deemed dose-limiting by the safety committee.
Cycle 1 (Each cycle is of 28 days)
Secondary Outcomes
Measure
Description
Time Frame
Part A - Clinical Benefit Rate (CBR) as Per Confirmed Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST 1.1)
The Clinical benefit rate (CBR) is defined as percentage of participants with tumor responses (as assessed by the Investigators) of CR, PR and durable SD (SD of ≥ 4 months duration). Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Stable Disease (SD) is concluded when the response does not qualify for CR, PR or Progression. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Advanced or unresectable solid tumors including those who have progressed on (or not been able to tolerate due to medical comorbidities or unacceptable toxicity) standard anticancer therapy or for whom no other approved conventional therapy exists
Eastern Cooperative Oncology Group Performance Status of 0 to 1
Exclusion Criteria:
Prior autologous stem cell transplant ≤ 3 months before first dose or those who have not recovered
Symptomatic or uncontrolled ulcers (gastric or duodenal), particularly those with a history of and/or risk of perforation and gastrointestinal tract hemorrhages
Impaired cardiac function or clinically significant cardiac diseases
Poor bone marrow reserve as assessed by Investigator
Refer to protocol defined exclusion criteria for parts C and D. Other protocol-defined inclusion/exclusion criteria apply
Hollebecque A, Salvagni S, Plummer R, Isambert N, Niccoli P, Capdevila J, Curigliano G, Moreno V, Martin-Romano P, Baudin E, Arias M, Mora S, de Alvaro J, Di Martino J, Parra-Palau JL, Sanchez-Perez T, Aronchik I, Filvaroff EH, Lamba M, Nikolova Z, de Bono JS. Phase I Study of Lysine-Specific Demethylase 1 Inhibitor, CC-90011, in Patients with Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma. Clin Cancer Res. 2021 Jan 15;27(2):438-446. doi: 10.1158/1078-0432.CCR-20-2380. Epub 2020 Oct 12.
Participants were not enrolled in Part C and Part D as the study was terminated early.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A 1.25 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received CC-90011 capsule orally once per week of different doses.
FG001
Part A 2.5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Nov 5, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Rifampicin
Drug
Specified dose on specified days
CC-90011 and Rifampicin
Itraconazole
Drug
Specified dose on specified days
CC-90011 and Itraconazole
From first dose (Day 1) till disease progression or death due to any cause (up to 803 days)
Part A - Objective Response Rate as Per Confirmed Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST 1.1)
The Objective Response Rate (ORR) is defined as the percentage of participants whose best response is CR or PR. Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
From first dose (Day 1) untill disease progression or death due to any cause (up to 803 days)
Part A - Duration of Response (DoR) Based on Confirmed Responses
Duration of response is measured from the time when criteria for CR/PR are first met (whichever is first recorded) until the first date at which progressive disease is objectively documented. Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
From first dose (Day 1) until disease progression or death due to any cause (up to 803 days)
Part A - Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from the first dose of CC-90011 to the first occurrence of disease progression or death from any cause based on Kaplan-Meier methodology. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
From first dose (Day 1) until disease progression or death due to any cause (up to 803 days)
Part A - Overall Survival (OS)
Overall Survival (OS) is defined as the time from the first dose of study drug to death due to any cause based on Kaplan-Meier methodology.
From first dose (Day 1) until death due to any cause (up to 803 days)
Part A - Maximum Observed Plasma Concentration (Cmax) of CC-90011
Blood samples were collected to assess Cmax. Prespecified to be reported for Part A only.
Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
Part A - Area Under the Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUCt) of CC-90011
Blood samples were collected to assess AUCt. Prespecified to be reported for Part A only.
Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
Part A - Time to Cmax (Tmax) of CC-90011
Blood samples were collected to assess Tmax. Prespecified to be reported for Part A only.
Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
Part A - Half-life (t1/2) of CC-90011
Blood samples were collected to assess CL/F. Prespecified to be reported for Part A only.
Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
Part A - Apparent Clearance (CL/F) of CC-90011
Blood samples were collected to assess CL/F. Prespecified to be reported for Part A only.
Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
Part A- Volume of Distribution (Vz/F) of CC-90011
Blood samples were collected to assess Vz/F. Prespecified to be reported for Part A only.
Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
Part B - Clinical Benefit Rate (CBR) as Per Confirmed Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST 1.1)
The Clinical Benefit Rate (CBR) is defined as tumor responses (as assessed by the Investigators) of CR, PR and durable SD (SD of ≥ 4 months duration). Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Stable Disease (SD) is concluded when the response does not qualify for CR, PR or Progression. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
From first dose (Day 1) until disease progression or death due to any cause (up to 720 days)
Part B - Objective Response Rate as Per Confirmed Best Overall Response Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST 1.1)
The Objective Response Rate (ORR) is defined as the percent of participants whose best response is CR or PR. Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
From first dose (Day 1) till disease progression or death due to any cause (up to 720 days)
Part B - Duration of Response (DoR)
Duration of response is measured from the time when criteria for CR/PR are first met (whichever is first recorded) until the first date at which progressive disease is objectively documented. Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
From first dose (Day 1) until disease progression or death due to any cause (up to 720 days)
Part B - Progression Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from the first dose of CC-90011 to the first occurrence of disease progression or death from any cause based on Kaplan-Meier methodology Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
From first dose (Day 1) until disease progression or death due to any cause (up to 720 days)
Part B - Overall Survival (OS)
Overall Survival (OS) is defined as the time from the first dose of study drug to death due to any cause based on Kaplan-Meier methodology.
From first dose (Day 1) until death due to any cause (up to 720 days)
Marseille
13273
France
Local Institution - 100
Villejuif
94805
France
Local Institution - 200
Bologna
40123
Italy
Local Institution - 201
Milan
20133
Italy
Local Institution - 202
Milan
20141
Italy
Local Institution - 501
Chuo-ku
Tokyo
104-0045
Japan
Local Institution - 502
Koto-Ku
Tokyo
135-8550
Japan
Local Institution - 500
Kashiwa
277-8577
Japan
Local Institution - 400
Barcelona
08035
Spain
Local Institution - 402
Madrid
28040
Spain
Local Institution - 404
Madrid
28041
Spain
Local Institution - 401
Santander
39008
Spain
Local Institution - 300
London
SW3 6JJ
United Kingdom
Local Institution - 301
Newcastle upon Tyne
NE7 7DN
United Kingdom
Derived
Hollebecque A, Salvagni S, Plummer R, Niccoli P, Capdevila J, Curigliano G, Moreno V, de Braud F, de Villambrosia SG, Martin-Romano P, Baudin E, Arias M, de Alvaro J, Parra-Palau JL, Sanchez-Perez T, Aronchik I, Filvaroff EH, Lamba M, Nikolova Z, de Bono JS. Clinical activity of CC-90011, an oral, potent, and reversible LSD1 inhibitor, in advanced malignancies. Cancer. 2022 Sep 1;128(17):3185-3195. doi: 10.1002/cncr.34366. Epub 2022 Jun 23.
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
FG003
Part A 10 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
FG004
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
FG005
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
FG006
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
FG007
Part A 80 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
FG008
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
FG009
Part B - Lung NETs - 60 mg
Participants with advanced low/intermediate-grade Lung Neuroendocrine tumors (NETs) received 60 mg of CC-90011 capsule orally once per week.
FG010
Part B - NEPC - 60 mg
Participants with neuroendocrine prostate carcinoma (NEPC) received 60 mg of CC-90011 capsule orally once per week.
FG011
Part B - MZL - 60 mg
Participants with relapsed and/or refractory (R/R) non-Hodgkin lymphoma (NHL) (marginal zone lymphoma [MZL], including extranodal marginal zone lymphoma [EMZL], splenic marginal zone lymphoma [SMZL], nodal marginal zone lymphoma [NMZL], and histologic transformation of marginal zone lymphoma (MZL) received 60 mg of CC-90011 capsule orally once per week.
FG012
Part B - Japanese Cohort - 60 mg
Japanese participants with relapsed and/or refractory (R/R) advanced unresectable solid tumors (including grade 2 neuroendocrine neoplasm [NENs]/NETs) and R/R non-Hodgkin lymphoma (NHLs) (including diffuse large B-cell lymphoma [DLBCL] and follicular lymphoma [FL] or MZL) received 60 mg of CC-90011 capsule orally once per week
FG0004 subjects
FG0015 subjects
FG0026 subjects
FG0034 subjects
FG0045 subjects
FG0056 subjects
FG0066 subjects
FG00710 subjects
FG0084 subjects
FG00914 subjects
FG0102 subjects
FG0113 subjects
FG0126 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
NOT COMPLETED
FG0004 subjects
FG0015 subjects
FG0026 subjects
FG0034 subjects
FG0045 subjects
FG0056 subjects
FG0066 subjects
FG00710 subjects
FG0084 subjects
FG00914 subjects
FG0102 subjects
FG0113 subjects
FG0126 subjects
Type
Comment
Reasons
Other reasons
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0052 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive disease
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Death
FG0004 subjects
FG0014 subjects
FG0023 subjects
FG0034 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A 1.25 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received CC-90011 capsule orally once per week of different doses.
BG001
Part A 2.5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
BG002
Part A 5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
BG003
Part A 10 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
BG004
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
BG005
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
BG006
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
BG007
Part A 80 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
BG008
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
BG009
Part B - Lung NETs - 60 mg
Participants with advanced low/intermediate-grade Lung Neuroendocrine tumors (NETs) received 60 mg of CC-90011 capsule orally once per week.
BG010
Part B - NEPC - 60 mg
Participants with neuroendocrine prostate carcinoma (NEPC) received 60 mg of CC-90011 capsule orally once per week.
BG011
Part B - MZL - 60 mg
Participants with relapsed and/or refractory (R/R) non-Hodgkin lymphoma (NHL) (marginal zone lymphoma [MZL], including extranodal marginal zone lymphoma [EMZL], splenic marginal zone lymphoma [SMZL], nodal marginal zone lymphoma [NMZL], and histologic transformation of marginal zone lymphoma (MZL) received 60 mg of CC-90011 capsule orally once per week.
BG012
Part B - Japanese Cohort - 60 mg
Japanese participants with relapsed and/or refractory (R/R) advanced unresectable solid tumors (including grade 2 neuroendocrine neoplasm [NENs]/NETs) and R/R non-Hodgkin lymphoma (NHLs) (including diffuse large B-cell lymphoma [DLBCL] and follicular lymphoma [FL] or MZL) received 60 mg of CC-90011 capsule orally once per week
BG013
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0015
BG0026
BG0034
BG0045
BG0056
BG0066
BG00710
BG0084
BG00914
BG0102
BG0113
BG0126
BG01375
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0013
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Part A - Number of Participants With Dose Limiting Toxicities (DLTs)
Dose-limiting toxicities (DLTs) during dose escalation are defined as follows, occurring within the Cycle 1 (28 days) DLT assessment period, unless clearly unrelated to CC-90011: Any Grade 4 non-hematologic toxicity; any non-hematologic toxicity Grade ≥ 3 except Grade 3 diarrhea, nausea, or vomiting of ≤ 3 days duration, Grade 3 rash resolving to Grade ≤ 2 within 7 days without recurrence, and Grade 3 fatigue resolving to Grade ≤ 2 within 7 days without recurrence. Hematological toxicities include febrile neutropenia, Grade 4 neutropenia > 7 days, Grade 4 thrombocytopenia > 7 days, or Grade ≥ 3 thrombocytopenia with significant bleeding. Any AE necessitating dose reduction during Cycle 1, or any other toxicity deemed dose-limiting by the safety committee. The MTD is the highest dose at which less than 33% of the population treated with CC-90011 suffer a DLT in the first cycle and at least 6 evaluable participants have been treated at this dose.
DLT Evaluable Population includes participants in Part A are evaluable for DLT if they received at least 75% of the total planned dose of CC-90011 during Cycle 1.
Posted
Count of Participants
Participants
Cycle 1 (Each cycle is of 28 days)
ID
Title
Description
OG000
Part A 1.25 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
OG001
Part A 2.5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
OG002
Part A 5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
OG003
Part A 10 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
OG004
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
OG005
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
OG006
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
OG007
Part A 80 mg
Units
Counts
Participants
OG0004
OG0014
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Part A - Clinical Benefit Rate (CBR) as Per Confirmed Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST 1.1)
The Clinical benefit rate (CBR) is defined as percentage of participants with tumor responses (as assessed by the Investigators) of CR, PR and durable SD (SD of ≥ 4 months duration). Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Stable Disease (SD) is concluded when the response does not qualify for CR, PR or Progression. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
The Treated Population included all participants who enrolled and received at least 1 dose of CC-90011 and prespecified to be reported for Part A only.
Posted
Number
95% Confidence Interval
percentage of participants
From first dose (Day 1) till disease progression or death due to any cause (up to 803 days)
ID
Title
Description
OG000
Part A 1.25 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
OG001
Part A 2.5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
Secondary
Part A - Objective Response Rate as Per Confirmed Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST 1.1)
The Objective Response Rate (ORR) is defined as the percentage of participants whose best response is CR or PR. Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
The Treated Population included all participants who enrolled and received at least 1 dose of CC-90011 and prespecified to be reported for Part A only
Posted
Number
95% Confidence Interval
percentage of participants
From first dose (Day 1) untill disease progression or death due to any cause (up to 803 days)
ID
Title
Description
OG000
Part A 1.25 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
OG001
Part A 2.5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
Secondary
Part A - Duration of Response (DoR) Based on Confirmed Responses
Duration of response is measured from the time when criteria for CR/PR are first met (whichever is first recorded) until the first date at which progressive disease is objectively documented. Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
The Treated Population included all participants who enrolled and received at least 1 dose of CC-90011. Treated Population with Confirmed Best Response of CR or PR. Prespecified to be reported for Part A only.
Posted
Number
95% Confidence Interval
months
From first dose (Day 1) until disease progression or death due to any cause (up to 803 days)
ID
Title
Description
OG000
Part A 1.25 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
OG001
Part A 2.5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
Secondary
Part A - Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from the first dose of CC-90011 to the first occurrence of disease progression or death from any cause based on Kaplan-Meier methodology. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
The Treated Population included all participants who enrolled and received at least 1 dose of CC-90011. Prespecified to be reported for Part A only.
Posted
Median
95% Confidence Interval
days
From first dose (Day 1) until disease progression or death due to any cause (up to 803 days)
ID
Title
Description
OG000
Part A 1.25 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
OG001
Part A 2.5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
OG002
Part A 5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
Secondary
Part A - Overall Survival (OS)
Overall Survival (OS) is defined as the time from the first dose of study drug to death due to any cause based on Kaplan-Meier methodology.
The Treated Population included all participants who enrolled and received at least 1 dose of CC-90011. Prespecified to be reported for Part A only.
Posted
Median
95% Confidence Interval
days
From first dose (Day 1) until death due to any cause (up to 803 days)
ID
Title
Description
OG000
Part A 1.25 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
OG001
Part A 2.5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
OG002
Part A 5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
OG003
Part A 10 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
Secondary
Part A - Maximum Observed Plasma Concentration (Cmax) of CC-90011
Blood samples were collected to assess Cmax. Prespecified to be reported for Part A only.
The PK Evaluable Population included all participants who enrolled, received at least 1 dose of CC-90011, and had at least 1 measurable concentration of CC-90011. Only participants with data available at the specified timepoints are included in the analysis. Prespecified to be reported for Part A only.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
ID
Title
Description
OG000
Part A 1.25 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
OG001
Part A 2.5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
OG002
Part A 5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
OG003
Secondary
Part A - Area Under the Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUCt) of CC-90011
Blood samples were collected to assess AUCt. Prespecified to be reported for Part A only.
The PK Evaluable Population included all participants who enrolled, received at least 1 dose of CC-90011, and had at least 1 measurable concentration of CC-90011. Only participants with data available at the specified timepoints are included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
ID
Title
Description
OG000
Part A 1.25 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
OG001
Part A 2.5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
OG002
Part A 5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
OG003
Secondary
Part A - Time to Cmax (Tmax) of CC-90011
Blood samples were collected to assess Tmax. Prespecified to be reported for Part A only.
The PK Evaluable Population included all participants who enrolled, received at least 1 dose of CC-90011, and had at least 1 measurable concentration of CC-90011. Only participants with data available at the specified timepoints are included in the analysis.
Posted
Median
Full Range
hours
Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
ID
Title
Description
OG000
Part A 1.25 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
OG001
Part A 2.5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
OG002
Part A 5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
OG003
Part A 10 mg
Secondary
Part A - Half-life (t1/2) of CC-90011
Blood samples were collected to assess CL/F. Prespecified to be reported for Part A only.
The PK Evaluable Population included all participants who enrolled, received at least 1 dose of CC-90011, and had at least 1 measurable concentration of CC-90011. Only participants with data available at the specified timepoints are included in the analysis.
Posted
Median
Full Range
hour
Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
ID
Title
Description
OG000
Part A 1.25 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
OG001
Part A 2.5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
OG002
Part A 5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
OG003
Part A 10 mg
Secondary
Part A - Apparent Clearance (CL/F) of CC-90011
Blood samples were collected to assess CL/F. Prespecified to be reported for Part A only.
The PK Evaluable Population included all participants who enrolled, received at least 1 dose of CC-90011, and had at least 1 measurable concentration of CC-90011. Only participants with data available at the specified timepoints are included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Litres per hours
Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
ID
Title
Description
OG000
Part A 1.25 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
OG001
Part A 2.5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
OG002
Part A 5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
OG003
Part A 10 mg
Secondary
Part A- Volume of Distribution (Vz/F) of CC-90011
Blood samples were collected to assess Vz/F. Prespecified to be reported for Part A only.
The PK Evaluable Population included all participants who enrolled, received at least 1 dose of CC-90011, and had at least 1 measurable concentration of CC-90011. Only participants with data available at the specified timepoints are included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Litre
Day 1 and Day 22 of Cycle 1 (Each cycle consist of 28 days)
ID
Title
Description
OG000
Part A 1.25 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 1.25 mg of CC-90011 capsule orally once per week.
OG001
Part A 2.5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
OG002
Part A 5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
OG003
Part A 10 mg
Secondary
Part B - Clinical Benefit Rate (CBR) as Per Confirmed Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST 1.1)
The Clinical Benefit Rate (CBR) is defined as tumor responses (as assessed by the Investigators) of CR, PR and durable SD (SD of ≥ 4 months duration). Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Stable Disease (SD) is concluded when the response does not qualify for CR, PR or Progression. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
The Treated Population included all participants who enrolled and received at least 1 dose of CC-90011. Prespecified to be reported for Part B only
Posted
Number
95% Confidence Interval
percentage of participants
From first dose (Day 1) until disease progression or death due to any cause (up to 720 days)
ID
Title
Description
OG000
Part B - Lung NETs - 60 mg
Participants with advanced low/intermediate-grade Lung Neuroendocrine tumors (NETs) received 60 mg of CC-90011 capsule orally once per week.
OG001
Part B - NEPC - 60 mg
Participants with neuroendocrine prostate carcinoma (NEPC) received 60 mg of CC-90011 capsule orally once per week.
Secondary
Part B - Objective Response Rate as Per Confirmed Best Overall Response Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST 1.1)
The Objective Response Rate (ORR) is defined as the percent of participants whose best response is CR or PR. Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
The Treated Population included all participants who enrolled and received at least 1 dose of CC-90011. Prespecified to be reported for Part B only.
Posted
Number
95% Confidence Interval
percentage of participants
From first dose (Day 1) till disease progression or death due to any cause (up to 720 days)
ID
Title
Description
OG000
Part B - Lung NETs - 60 mg
Participants with advanced low/intermediate-grade Lung Neuroendocrine tumors (NETs) received 60 mg of CC-90011 capsule orally once per week.
OG001
Part B - NEPC - 60 mg
Participants with neuroendocrine prostate carcinoma (NEPC) received 60 mg of CC-90011 capsule orally once per week.
Secondary
Part B - Duration of Response (DoR)
Duration of response is measured from the time when criteria for CR/PR are first met (whichever is first recorded) until the first date at which progressive disease is objectively documented. Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
The Treated Population included all participants who enrolled and received at least 1 dose of CC-90011. Treated Population with Confirmed Best Response of CR or PR. Prespecified to be reported for Part B only.
Posted
From first dose (Day 1) until disease progression or death due to any cause (up to 720 days)
ID
Title
Description
OG000
Part B - Lung NETs - 60 mg
Participants with advanced low/intermediate-grade Lung Neuroendocrine tumors (NETs) received 60 mg of CC-90011 capsule orally once per week.
OG001
Part B - NEPC - 60 mg
Participants with neuroendocrine prostate carcinoma (NEPC) received 60 mg of CC-90011 capsule orally once per week.
OG002
Secondary
Part B - Progression Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from the first dose of CC-90011 to the first occurrence of disease progression or death from any cause based on Kaplan-Meier methodology Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.
The Treated Population included all participants who enrolled and received at least 1 dose of CC-90011. Prespecified to be reported for Part B only
Posted
Median
95% Confidence Interval
days
From first dose (Day 1) until disease progression or death due to any cause (up to 720 days)
ID
Title
Description
OG000
Part B - Lung NETs - 60 mg
Participants with advanced low/intermediate-grade Lung Neuroendocrine tumors (NETs) received 60 mg of CC-90011 capsule orally once per week.
OG001
Part B - NEPC - 60 mg
Participants with neuroendocrine prostate carcinoma (NEPC) received 60 mg of CC-90011 capsule orally once per week.
OG002
Part B - MZL - 60 mg
Participants with relapsed and/or refractory (R/R) non-Hodgkin lymphoma (NHL) (marginal zone lymphoma [MZL], including extranodal marginal zone lymphoma [EMZL], splenic marginal zone lymphoma [SMZL], nodal marginal zone lymphoma [NMZL], and histologic transformation of marginal zone lymphoma (MZL) received 60 mg of CC-90011 capsule orally once per week.
Secondary
Part B - Overall Survival (OS)
Overall Survival (OS) is defined as the time from the first dose of study drug to death due to any cause based on Kaplan-Meier methodology.
The Treated Population included all participants who enrolled and received at least 1 dose of CC-90011. Prespecified to be reported for Part B only.
Posted
Median
95% Confidence Interval
days
From first dose (Day 1) until death due to any cause (up to 720 days)
ID
Title
Description
OG000
Part B - Lung NETs - 60 mg
Participants with advanced low/intermediate-grade Lung Neuroendocrine tumors (NETs) received 60 mg of CC-90011 capsule orally once per week.
OG001
Part B - NEPC - 60 mg
Participants with neuroendocrine prostate carcinoma (NEPC) received 60 mg of CC-90011 capsule orally once per week.
OG002
Part B - MZL - 60 mg
Participants with relapsed and/or refractory (R/R) non-Hodgkin lymphoma (NHL) (marginal zone lymphoma [MZL], including extranodal marginal zone lymphoma [EMZL], splenic marginal zone lymphoma [SMZL], nodal marginal zone lymphoma [NMZL], and histologic transformation of marginal zone lymphoma (MZL) received 60 mg of CC-90011 capsule orally once per week.
Primary
Part A - Maximum Tolerated Dose (MTDs)
The MTD is the highest dose at which less than 33% of the population treated with CC-90011 suffer a DLT in the first cycle and at least 6 evaluable participants have been treated at this dose. Dose-limiting toxicities (DLTs) during dose escalation are defined as follows, occurring within the Cycle 1 (28 days) DLT assessment period, unless clearly unrelated to CC-90011: Any Grade 4 non-hematologic toxicity; any non-hematologic toxicity Grade ≥ 3 except Grade 3 diarrhea, nausea, or vomiting of ≤ 3 days duration, Grade 3 rash resolving to Grade ≤ 2 within 7 days without recurrence, and Grade 3 fatigue resolving to Grade ≤ 2 within 7 days without recurrence. Hematological toxicities include febrile neutropenia, Grade 4 neutropenia > 7 days, Grade 4 thrombocytopenia > 7 days, or Grade ≥ 3 thrombocytopenia with significant bleeding. Any AE necessitating dose reduction during Cycle 1, or any other toxicity deemed dose-limiting by the safety committee.
DLT Evaluable Population includes participants in Part A are evaluable for DLT if they received at least 75% of the total planned dose of CC-90011 during Cycle 1.
Posted
Number
milligram
Cycle 1 (Each cycle is of 28 days)
ID
Title
Description
OG000
Part A - All DLT Evaluable Participants
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received CC-90011 capsule orally once per week of different doses.
Units
Counts
Time Frame
All cause mortality was collected in Part A (up to 803 days) and Part B (up to 720 days). Adverse Events (AEs) and Serious AEs were collected from first dose (Day 1) and up to 28 days after last dose for participants in Part A (up to approximately 114 weeks) and Part B (up to approximately 256 weeks).
Description
All cause mortality, serious adverse events and non serious adverse events were collected for all the treated participants. Prespecified to be collected combined for Part B.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A 1.25 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received CC-90011 capsule orally once per week of different doses.
4
4
2
4
4
4
EG001
Part A 2.5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 2.5 mg of CC-90011 capsule orally once per week.
4
5
2
5
5
5
EG002
Part A 5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
3
6
2
6
5
6
EG003
Part A 10 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
4
4
0
4
3
4
EG004
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
2
5
0
5
5
5
EG005
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
3
6
5
6
6
6
EG006
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
5
6
3
6
6
6
EG007
Part A 80 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
7
10
6
10
10
10
EG008
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
3
4
3
4
4
4
EG009
Part B 60 mg
Participants with Lung NETs, or NEPC, or MZL received 60 mg of CC-90011 capsule orally once per week.
14
25
7
25
25
25
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG0030 affected4 at risk
EG0040 affected5 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected10 at risk
EG0080 affected4 at risk
EG0091 affected25 at risk
Neutropenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Colitis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Duodenal obstruction
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Haematemesis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Oesophageal ulcer
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Chest pain
General disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Fatigue
General disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
General physical health deterioration
General disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Pyrexia
General disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Cholecystitis
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hepatic haemorrhage
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hepatic pain
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Biliary tract infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Cystitis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Wound infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Oxygen saturation decreased
Investigations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Weight decreased
Investigations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Gout
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Metastases to skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Metastasis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Cauda equina syndrome
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Cerebrovascular accident
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected5 at risk
EG0021 affected6 at risk
EG0033 affected4 at risk
EG0040 affected5 at risk
EG0054 affected6 at risk
EG0061 affected6 at risk
EG0072 affected10 at risk
EG0081 affected4 at risk
EG0098 affected25 at risk
Leukopenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Ear pain
Ear and labyrinth disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Excessive cerumen production
Ear and labyrinth disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Vertigo
Ear and labyrinth disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Cushing's syndrome
Endocrine disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Conjunctival haemorrhage
Eye disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Eye pain
Eye disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Vitreous floaters
Eye disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
27.0
Systematic Assessment
EG0002 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Ascites
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Colitis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0023 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0022 affected6 at risk
EG003
Dry mouth
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
27.0
Systematic Assessment
EG0002 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Gastritis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Melaena
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Mesenteric vein thrombosis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
27.0
Systematic Assessment
EG0002 affected4 at risk
EG0012 affected5 at risk
EG0022 affected6 at risk
EG003
Oral discomfort
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
27.0
Systematic Assessment
EG0002 affected4 at risk
EG0013 affected5 at risk
EG0021 affected6 at risk
EG003
Asthenia
General disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected5 at risk
EG0021 affected6 at risk
EG003
Catheter site pain
General disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Chest discomfort
General disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0021 affected6 at risk
EG003
Fatigue
General disorders
27.0
Systematic Assessment
EG0002 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Hyperthermia
General disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Influenza like illness
General disorders
27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Non-cardiac chest pain
General disorders
27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Oedema peripheral
General disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0021 affected6 at risk
EG003
Pain
General disorders
27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Pyrexia
General disorders
27.0
Systematic Assessment
EG0002 affected4 at risk
EG0011 affected5 at risk
EG0021 affected6 at risk
EG003
Hepatic cytolysis
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Hepatic pain
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hepatitis cholestatic
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Bronchitis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Ear infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Erysipelas
Infections and infestations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Influenza
Infections and infestations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Lower respiratory tract infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Nail infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Oral candidiasis
Infections and infestations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Oral fungal infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Tooth abscess
Infections and infestations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Wound infection
Infections and infestations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0022 affected6 at risk
EG003
Amylase increased
Investigations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0022 affected6 at risk
EG003
Blood alkaline phosphatase increased
Investigations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Blood bilirubin increased
Investigations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Blood creatinine increased
Investigations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Lipase increased
Investigations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Weight decreased
Investigations
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Gout
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected5 at risk
EG0020 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Tendon disorder
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Trismus
Musculoskeletal and connective tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Ataxia
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Cauda equina syndrome
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Cerebral ischaemia
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Dizziness
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Dysarthria
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Dyskinesia
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Headache
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hypoaesthesia
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hypoglossal nerve disorder
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Neuralgia
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Partial seizures
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Sciatica
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Somnolence
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Syncope
Nervous system disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Confusional state
Psychiatric disorders
27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Depression
Psychiatric disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Hallucination, visual
Psychiatric disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Initial insomnia
Psychiatric disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Insomnia
Psychiatric disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Dysuria
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Haematuria
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Urinary retention
Renal and urinary disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Nipple pain
Reproductive system and breast disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Testicular pain
Reproductive system and breast disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Testicular swelling
Reproductive system and breast disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0022 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Oropharyngeal discomfort
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Nail dystrophy
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Rash vesicular
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Skin haemorrhage
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Haematoma
Vascular disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Hot flush
Vascular disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Hypotension
Vascular disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected5 at risk
EG0020 affected6 at risk
EG003
Lymphoedema
Vascular disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0020 affected6 at risk
EG003
Subclavian vein thrombosis
Vascular disorders
27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected5 at risk
EG0021 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
OG008
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
4
OG0045
OG0056
OG0066
OG0079
OG0084
0
OG0040
OG0050
OG0061
OG0072
OG0084
OG002
Part A 5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
OG003
Part A 10 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
OG004
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
OG005
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
OG006
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
OG007
Part A 80 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
OG008
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
Units
Counts
Participants
OG0004
OG0015
OG0026
OG0034
OG0045
OG0056
OG0066
OG00710
OG0084
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 52.2)
OG00216.7(0.4 to 64.1)
OG0030.0(0.0 to 60.2)
OG00420.0(0.5 to 71.6)
OG00550.0(11.8 to 88.2)
OG00633.3(4.3 to 77.7)
OG00730.0(6.7 to 65.2)
OG0080.0(0.0 to 60.2)
OG002
Part A 5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
OG003
Part A 10 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
OG004
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
OG005
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
OG006
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
OG007
Part A 80 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
OG008
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
Units
Counts
Participants
OG0004
OG0015
OG0026
OG0034
OG0045
OG0056
OG0066
OG00710
OG0084
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 52.2)
OG0020.0(0.0 to 45.9)
OG0030.0(0.0 to 60.2)
OG0040.0(0.0 to 52.2)
OG0050.0(0.0 to 45.9)
OG0060.0(0.0 to 45.9)
OG00710.0(0.3 to 44.5)
OG0080.0(0.0 to 60.2)
OG002
Part A 5 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 5 mg of CC-90011 capsule orally once per week.
OG003
Part A 10 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
OG004
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
OG005
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
OG006
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
OG007
Part A 80 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
OG008
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
Title
Denominators
Categories
Title
Measurements
OG007NA(NA to NA)Not estimated due to inadequate number of events with CR or PR.
OG003
Part A 10 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
OG004
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
OG005
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
OG006
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
OG007
Part A 80 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
OG008
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
Units
Counts
Participants
OG0004
OG0015
OG0026
OG0034
OG0045
OG0056
OG0066
OG00710
OG0084
Title
Denominators
Categories
Title
Measurements
OG00096.0(50.0 to 103.0)
OG00153.0(50.0 to 189.0)
OG002107.0(22.0 to NA)Not estimated due to inadequate number of events
OG00351.5(22.0 to 106.0)
OG004588.0(50.0 to 588.0)
OG005162.0(20.0 to NA)Not estimated due to inadequate number of events
OG006111.5(53.0 to NA)Not estimated due to inadequate number of events
OG00752.0(17.0 to 164.0)
OG008107.0(61.0 to 238.0)
OG004
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
OG005
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
OG006
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
OG007
Part A 80 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
OG008
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
Units
Counts
Participants
OG0004
OG0015
OG0026
OG0034
OG0045
OG0056
OG0066
OG00710
OG0084
Title
Denominators
Categories
Title
Measurements
OG000315.0(108.0 to 803.0)
OG001189.0(53.0 to 204.0)
OG002611.0(78.0 to NA)Not estimated due to inadequate number of events
OG003322.5(114.0 to 593.0)
OG004NA(116.0 to NA)Not estimated due to inadequate number of events
OG005NA(81.0 to NA)Not estimated due to inadequate number of events
OG006NA(153.0 to NA)Not estimated due to inadequate number of events
OG007139.0(27.0 to NA)Not estimated due to inadequate number of events
OG008238.0(185.0 to NA)Not estimated due to inadequate number of events
Part A 10 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
OG004
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
OG005
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
OG006
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
OG007
Part A 80 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
OG008
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
Units
Counts
Participants
OG0004
OG0015
OG0026
OG0034
OG0045
OG0056
OG0066
OG00710
OG0084
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0026
ParticipantsOG0034
ParticipantsOG0045
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG00710
ParticipantsOG0084
Title
Measurements
OG0000.4077± 35.18
OG0010.8042± 46.38
OG0021.520± 39.99
OG003
Cycle Day 22
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0033
Part A 10 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
OG004
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
OG005
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
OG006
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
OG007
Part A 80 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
OG008
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
Units
Counts
Participants
OG0004
OG0015
OG0026
OG0034
OG0045
OG0056
OG0066
OG00710
OG0084
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0026
ParticipantsOG0034
ParticipantsOG0045
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG00710
ParticipantsOG0084
Title
Measurements
OG0005.806± 55.98
OG00124.47± 76.85
OG00244.77± 35.77
OG003
Cycle Day 22
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0033
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
OG004
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
OG005
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
OG006
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
OG007
Part A 80 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
OG008
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
Units
Counts
Participants
OG0004
OG0015
OG0026
OG0034
OG0045
OG0056
OG0066
OG00710
OG0084
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0026
ParticipantsOG0034
ParticipantsOG0045
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG00710
ParticipantsOG0084
Title
Measurements
OG0002.083(2.050 to 4.000)
OG0012.017(2.000 to 4.083)
OG0024.042(2.000 to 4.133)
OG003
Cycle Day 22
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0033
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
OG004
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
OG005
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
OG006
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
OG007
Part A 80 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
OG008
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
Units
Counts
Participants
OG0004
OG0015
OG0026
OG0034
OG0045
OG0056
OG0066
OG00710
OG0084
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0026
ParticipantsOG0034
ParticipantsOG0045
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG00710
ParticipantsOG0084
Title
Measurements
OG00034.33(20.93 to 66.63)
OG00173.07(41.84 to 83.70)
OG00279.30(28.86 to 108.39)
OG003
Cycle Day 22
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0033
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
OG004
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
OG005
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
OG006
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
OG007
Part A 80 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
OG008
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
Units
Counts
Participants
OG0004
OG0015
OG0026
OG0034
OG0045
OG0056
OG0066
OG00710
OG0084
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0034
ParticipantsOG0045
ParticipantsOG0055
ParticipantsOG0065
ParticipantsOG00710
ParticipantsOG0084
Title
Measurements
OG00135.61± NANot calculated due to 1 participant analyzed.
OG00295.70± 20.82
OG00380.08± 44.68
OG004
Cycle 1 Day 22
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 10 mg of CC-90011 capsule orally once per week.
OG004
Part A 20 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 20 mg of CC-90011 capsule orally once per week.
OG005
Part A 40 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 40 mg of CC-90011 capsule orally once per week.
OG006
Part A 60 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 60 mg of CC-90011 capsule orally once per week.
OG007
Part A 80 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 80 mg of CC-90011 capsule orally once per week.
OG008
Part A 120 mg
Participants with Advanced Solid Tumors and Non-Hodgkin Lymphomas received 120 mg of CC-90011 capsule orally once per week.
Units
Counts
Participants
OG0004
OG0015
OG0026
OG0034
OG0045
OG0056
OG0066
OG00710
OG0084
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0034
ParticipantsOG0044
ParticipantsOG0055
ParticipantsOG0065
ParticipantsOG00710
ParticipantsOG0084
Title
Measurements
OG0013400.66± NANot calculated due to 1 participant analyzed.
OG0027814.20± 50.12
OG0038076.70± 44.02
OG004
Cycle 1 Day 22
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Part B - MZL - 60 mg
Participants with relapsed and/or refractory (R/R) non-Hodgkin lymphoma (NHL) (marginal zone lymphoma [MZL], including extranodal marginal zone lymphoma [EMZL], splenic marginal zone lymphoma [SMZL], nodal marginal zone lymphoma [NMZL], and histologic transformation of marginal zone lymphoma (MZL) received 60 mg of CC-90011 capsule orally once per week.
OG003
Part B - Japanese Cohort - 60 mg
Japanese participants with relapsed and/or refractory (R/R) advanced unresectable solid tumors (including grade 2 neuroendocrine neoplasm [NENs]/NETs) and R/R non-Hodgkin lymphoma (NHLs) (including diffuse large B-cell lymphoma [DLBCL] and follicular lymphoma [FL] or MZL) received 60 mg of CC-90011 capsule orally once per week
Units
Counts
Participants
OG00014
OG0012
OG0023
OG0036
Title
Denominators
Categories
Title
Measurements
OG00050.0(23.0 to 77.0)
OG0010.0(0.0 to 84.2)
OG0020.0(0.0 to 70.8)
OG00316.7(0.4 to 64.1)
OG002
Part B - MZL - 60 mg
Participants with relapsed and/or refractory (R/R) non-Hodgkin lymphoma (NHL) (marginal zone lymphoma [MZL], including extranodal marginal zone lymphoma [EMZL], splenic marginal zone lymphoma [SMZL], nodal marginal zone lymphoma [NMZL], and histologic transformation of marginal zone lymphoma (MZL) received 60 mg of CC-90011 capsule orally once per week.
OG003
Part B - Japanese Cohort - 60 mg
Japanese participants with relapsed and/or refractory (R/R) advanced unresectable solid tumors (including grade 2 neuroendocrine neoplasm [NENs]/NETs) and R/R non-Hodgkin lymphoma (NHLs) (including diffuse large B-cell lymphoma [DLBCL] and follicular lymphoma [FL] or MZL) received 60 mg of CC-90011 capsule orally once per week
Units
Counts
Participants
OG00014
OG0012
OG0023
OG0036
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 23.2)
OG0010.0(0.0 to 84.2)
OG0020.0(0.0 to 70.8)
OG0030.0(0.0 to 45.9)
Part B - MZL - 60 mg
Participants with relapsed and/or refractory (R/R) non-Hodgkin lymphoma (NHL) (marginal zone lymphoma [MZL], including extranodal marginal zone lymphoma [EMZL], splenic marginal zone lymphoma [SMZL], nodal marginal zone lymphoma [NMZL], and histologic transformation of marginal zone lymphoma (MZL) received 60 mg of CC-90011 capsule orally once per week.
OG003
Part B - Japanese Cohort - 60 mg
Japanese participants with relapsed and/or refractory (R/R) advanced unresectable solid tumors (including grade 2 neuroendocrine neoplasm [NENs]/NETs) and R/R non-Hodgkin lymphoma (NHLs) (including diffuse large B-cell lymphoma [DLBCL] and follicular lymphoma [FL] or MZL) received 60 mg of CC-90011 capsule orally once per week
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG003
Part B - Japanese Cohort - 60 mg
Japanese participants with relapsed and/or refractory (R/R) advanced unresectable solid tumors (including grade 2 neuroendocrine neoplasm [NENs]/NETs) and R/R non-Hodgkin lymphoma (NHLs) (including diffuse large B-cell lymphoma [DLBCL] and follicular lymphoma [FL] or MZL) received 60 mg of CC-90011 capsule orally once per week
Units
Counts
Participants
OG00014
OG0012
OG0023
OG0036
Title
Denominators
Categories
Title
Measurements
OG000140.5(51.0 to 176.0)
OG00138.0(24.0 to NA)UL of 95% CI not estimated due to insufficient number of events.
OG00228.0(22.0 to NA)UL of 95% CI not estimated due to insufficient number of events.
OG00381.5(26.0 to NA)UL of 95% CI not estimated due to insufficient number of events.
OG003
Part B - Japanese Cohort - 60 mg
Japanese participants with relapsed and/or refractory (R/R) advanced unresectable solid tumors (including grade 2 neuroendocrine neoplasm [NENs]/NETs) and R/R non-Hodgkin lymphoma (NHLs) (including diffuse large B-cell lymphoma [DLBCL] and follicular lymphoma [FL] or MZL) received 60 mg of CC-90011 capsule orally once per week
Units
Counts
Participants
OG00014
OG0012
OG0023
OG0036
Title
Denominators
Categories
Title
Measurements
OG000720.0(73.0 to NA)UL of 95% CI not estimated due to insufficient number of events.
OG001307.0(214.0 to NA)UL of 95% CI not estimated due to insufficient number of events.
OG002NA(147.0 to NA)Median and UL of 95% CI not estimated due to insufficient number of events.
OG003180.0(156.0 to NA)UL of 95% CI not estimated due to insufficient number of events.