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A Phase 1b Open-label Study to Evaluate the Safety and Efficacy of CC-122 With Obinutuzumab (GA101) in Relapsed/Refractory DLBCL and iNHL.

NCT02417285 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-10-23

No results posted yet for this study

Summary

CC-122-NHL-001 study is a multicenter, open-label, phase Ib study with dose escalation and expansion parts. It evaluates the safety, tolerability and clinical pharmacokinetics of CC-122 in combination with obinutuzumab (GA101). The study is also assessing the preliminary efficacy of the combination as well as pharmacodynamic and tumor biomarkers as exploratory objectives. In the dose escalation part, the safety and tolerability of increasing doses of CC-122 administered with a fixed dose of obinutuzumab will be administered to identify the maximum tolerated dose. In the dose expansion part, more patients will be enrolled at a CC-122 dose selected from the escalation part of the study in combination with fixed dose obinutuzumab to further study safety and efficacy.

Conditions

  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin

Interventions

DRUG

Obinutuzumab

1000 mg administered IV on Days 2, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 though 8.

DRUG

CC-122

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).

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-22
Primary Completion
2019-05-27
Completion
2023-09-28

Countries

  • France
  • Italy
  • Netherlands

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02417285 on ClinicalTrials.gov