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CC-115

Phase 1

Glioblastoma Multiforme | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Oct 5, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment118
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01353625Study to Assess Safety and Tolerability of Oral CC-115 for Patients With Advanced Solid Tumors, and Hematologic Malignancies.PHASE1 COMPLETED 118 — — Apr 25, 2011Mar 12, 2021Oct 5, 202117 United States, France +2
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Study Endpoints
Primary Endpoints
Dose-Limiting Toxicity
Continuously for 28 days after starting treatment
Non-Tolerated Dose
Continuously for 28 days after starting treatment
Maximum Tolerated Dose
Continuously for 28 days after starting treatment
Maximum Observed Concentration in Plasma of CC-115
Days 1, 2, 15, 16 of treatment
Area Under the Concentration-Time Curve for CC-115
Days 1, 2, 15 and 16 of treatment
Time to Maximum Concentration of CC-115
Days 1, 2, 15, and 16 of treatment
Terminal Half-Life for CC-115
Days 1, 2, 15, and 16 of treatment
Apparent Total Body Clearance of CC-115
Days 1, 2, 15 and 16 of treatment
Apparent Volume of Distribution of CC-115
Days 1, 2, 15, and 16 of treatment
Accumulation Index of CC-115
Days 1, 2, 15 and 16 of treatment
Secondary Endpoints
Pharmacodynamics
Screening (within 28 days prior to first dose of study drug) and Days 1, 2, 8, 15, 22, 28, 155, and end of treatment
Anti-Tumor Efficacy
Every 2-3 months until proof of tumor progression
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CC-115EXPERIMENTAL -
Interventions
NameTypeDescription
CC-115DRUGPart A (actively recruiting): Dose level starts with 0.5mg daily by mouth in cycles of 28 days. Level increases for different patient cohorts in 100% or 50% increments until optimal dose schedule is established for further study. Treatment continues for as long as patient benefits (i.e., until disease progression or unacceptable toxicity). Part B: Optimal dose schedule is administered in 28-day cycles until disease progression.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Histologically-confirmed advanced solid tumor, chronic lymphocytic leukemia, small lymphocytic lymphoma, T-cell prolymphocytic leukemia, Non-Hodgkin Lymphoma or multiple myeloma * Progressed or not tolerated standard therapy, and no further standard therapy is available * Arch...

Countries:United StatesFranceGermanySpain
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