Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CC-223, erlotinib · 1 trial · 2 indications
Number of participants with adverse events
Maximum tolerated dose (MTD)
Pk-Maximum observed concentration in plasma (Cmax)
Area under the plasma concentration-time curve (AUC)
PK-Time to maximum concentration (Tmax)
PK-Terminal half-life (T1/2)
PK-Apparent total body clearance (CL/F)
PK-Apparent volume of distribution (Vz/F)
| Arm | Type | Description |
|---|---|---|
| CC-223/erlotinib concurrent | EXPERIMENTAL | Cohorts will receive escalating continuous daily doses (15 mg and 30 mg) of CC-223 in capsules concurrently with at least two different daily dose levels of erlotinib tablets (100 mg and 150 mg) in 28-day cycles. |
| CC-223/oral azacitidine concurrent | EXPERIMENTAL | Cohorts will receive escalating continuous daily doses of CC-223 (15 mg and 30 mg) with one or more dose levels of oral azacitidine (200 mg or 300 mg, as two or three 100 mg tablets) administered on Day 1 to 21 of each 28-day cycle. |
| CC-223/oral azacitidine sequential | EXPERIMENTAL | Cohorts will receive escalating continuous daily dose levels of CC-223 (15 mg and 30 mg) administered on Days 8 through 28 sequentially with one or more dose levels of of oral azacitidine (200 mg or 300 mg, as two or three 100 mg tablets) administered on Days 1 to 7 of each 28-day cycle |
| Name | Type | Description |
|---|---|---|
| CC-223, erlotinib | DRUG | Dose escalation: Combination doses start with 15 mg CC-223 and 100 mg erlotinib, or 15 mg CC-223 and 150 mg erlotonib, administered in 28-day cycles. Combination dose levels increase sequentially using predefined regimens until non-tolerated dose levels are established and a maximum tolerated dose combination has been identified for further study. Dose expansion: The maximum tolerated doses are evaluated further for evidence of preliminary efficacy |
| CC-223, oral azacitidine | DRUG | Dose escalation: Combination doses start with 15 mg CC-223 and 200 mg oral azacitidine, administered in 28-day cycle. Combination dose levels increase sequentially using predefined regimens until non-tolerated dose levels are established and a maximum tolerated dose combination has been identified for further study. Dose expansion: The maximum tolerated doses are evaluated further for evidence of preliminary efficacy |
Inclusion Criteria: 1. Men and women, 18 years or older, with histologically or cytologically-confirmed, Stage IIIB/IV Non-Small Cell Lung Cancer with tumor progression following at least one prior treatment regimen (either chemotherapy or an Epidermal Growth Factor Receptor inhibitor) for advanced...
CC-223 is an investigational small molecule being studied for multiple myeloma, non-small cell lung cancer, and other advanced solid tumors. It has also been evaluated in healthy volunteers for safety and pharmacokinetic studies. All clinical trials of CC-223 are in Phase 1 and have been completed.
CC-223 is a small molecule being developed by Bristol-Myers Squibb. Its molecular target has not been disclosed in available clinical trial information. The drug has been studied in Phase 1 trials for multiple myeloma, non-small cell lung cancer, and other advanced cancers.
CC-223 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The drug is an investigational small molecule that has completed Phase 1 clinical trials for multiple myeloma, non-small cell lung cancer, and other advanced solid tumors.
CC-223 is in Phase 1 clinical development. All four clinical trials of CC-223 are Phase 1 studies and have been completed. The drug is investigational and has not been approved by regulatory authorities for any indication.
CC-223 has been studied in four completed Phase 1 trials. NCT01177397 assessed safety and efficacy in advanced solid tumors, non-Hodgkin lymphoma, or multiple myeloma. NCT01545947 studied CC-223 with erlotinib or oral azacitidine in non-small cell lung cancer. NCT01611467 and NCT01896323 evaluated metabolism and drug interactions in healthy volunteers.
CC-223 is also known by the code name CC-223. No other alternative names have been disclosed in clinical trial records. The drug is an investigational small molecule being developed by Bristol-Myers Squibb for multiple myeloma and other cancers.