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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02417285 | A Phase 1b Open-label Study to Evaluate the Safety and Efficacy of CC-122 With Obinutuzumab (GA101) in Relapsed/Refractory DLBCL and iNHL. | PHASE1 | COMPLETED | 75 | — | — | May 22, 2015 | Sep 28, 2023 | Oct 23, 2023 | 8 | France, Italy +1 |
Number of participants with adverse events
| Arm | Type | Description |
|---|---|---|
| CC-122 in combination with Obinutuzumab | EXPERIMENTAL | CC-122 will be administered orally QD starting on Day 1 for 5 consecutive days followed by 2 days off study drug every 7 days (5/7-day schedule) in each 28-day cycle in combination with Obinutuzumab administered as an intravenous (IV) infusion at a dose of 1000 mg on Days 2, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 through 8. |
| Name | Type | Description |
|---|---|---|
| Obinutuzumab | DRUG | 1000 mg administered IV on Days 2, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 though 8. |
| CC-122 | DRUG | CC-122 1mg, 2mg, 3mg, 4mg or 5mg administered orally once daily on a 5/7-day schedule in each 28-day cycle. In addition, subjects will be enrolled on the CC-122 formulated capsule (F6) and evaluated for safety and tolerability in combination with GA101 (Obinituzumab) in a separate cohort. The CC-122 dose will be escalated until the MTD is established on the CC-122 formulated capsule (F6) in combination with GA101 (Obinituzumab). |
Inclusion Criteria: 1. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted. 2. ≥ 18 years of age or older at the time of signing the informed consent document. Entry Criteria Specific for Dose-Escalation Phase (Part A) 3. ...