Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01545947 | Study Assessing Safety, Pharmacokinetics and Efficacy of CC-223 With Either Erlotinib or Oral Azacitidine in Advanced Non-Small Cell Lung Cancer | PHASE1 | COMPLETED | 76 | — | — | May 1, 2012 | Dec 11, 2014 | Nov 12, 2019 | 9 | United States, Spain |
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...