A Phase 1b Open-label Study to Evaluate the Safety and Efficacy of CC-122 With Obinutuzumab (GA101) in Relapsed/Refractory DLBCL and iNHL.
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|ClinicalTrials.gov Identifier: NCT02417285|
Recruitment Status : Active, not recruiting
First Posted : April 15, 2015
Last Update Posted : April 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin||Drug: Obinutuzumab Drug: CC-122||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Open-label Study to Evaluate the Safety and Efficacy of CC-122 in Combination With Obinutuzumab (GA101) in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Indolent Non-Hodgkin's Lymphoma|
|Actual Study Start Date :||May 22, 2015|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: CC-122 in combination with Obinutuzumab
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.
1000 mg administered IV on Days 2, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 though 8.
Other Name: GA-101
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).
- Adverse Events (AEs) [ Time Frame: Approximately 6 years ]Number of participants with adverse events
- Tumor Response [ Time Frame: Approximately 6 years ]Percentage of subjects with complete response (CR) or partial response (PR) Tumor response will be determined by the Investigator, based on modification of the modified International Working Group (IWG) Response Criteria for Malignant Lymphoma (Cheson,2007) criteria, and summarized using frequency tabulation by dose cohort and tumor type.
- Response Duration [ Time Frame: Approximately 6 years ]Duration from the time when criteria for response (CR or PR) are met to disease relapse/progression using modified IWG evaluation criteria.
- Progression-free Survival (PFS) [ Time Frame: Approximately 6 years ]Number of participants who survive without disease progression/relapse (using modified IWG evaluation criteria) or death as a result of any cause and time from the first dose date to disease progression/relapse or death, whichever occurs first
- Pharmacokinetics - Cmax [ Time Frame: up to 8 months ]Maximum Observed Concentration in plasma
- Pharmacokinetics AUC [ Time Frame: Up to 8 months ]Area under the Concentration-time Curve
- Pharmacokinetics Tmax [ Time Frame: Up to 8 months ]Time to Maximum Concentration
- Pharmacokinetics T1/2 [ Time Frame: Up to 8 months ]Terminal half-life (t1/2)
- Pharmacokinetics - CL/F [ Time Frame: Up to 8 months ]Apparent total body clearance
- Pharmacokinetics ‐ Vz/f [ Time Frame: Up to 8 months ]Apparent volume of distribution
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02417285
|Borddeaux Cedex, France, 33076|
|Institut Paoli Calmettes|
|Marseille cedex, France, 13273|
|Centre hospitalier Lyon Sud Hematologie|
|Pierre-Bénite cedex, France, 69495|
|Institut Gustave Roussy|
|Villejuif Cedex, France, 94805|
|Institute of Hematology and Medical Oncology L. and A. Seragnoli|
|Bologna, Italy, 40138|
|Azienda Ospedaliera Citta della Salute e della Scienza di Torino|
|Torino, Italy, 10126|
|Academisch Medisch Centrum|
|Amsterdam, Netherlands, 1105|
|Erasmus Medical Center-Daniel den Hoed|
|Rotterdam, Netherlands, 3075 EA|
|Study Director:||Zariana Nikolova, MD, PhD||Celgene Corporation|