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NCT01084252 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies
A Phase 1 study of Hematological Malignancy, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 351
- Enrollment target
- 20
- Study locations
NCT01084252: Completed Phase 1 study of Hematological Malignancy, sponsored by Sanofi.
NCT01084252 is a Phase 1 study of Hematological Malignancy that has completed, run by Sanofi. The registered enrollment target is 351 participants, above the 83-participant average among 9 other Hematological Malignancy trials with a reported enrollment target (323% higher). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01084252, a Phase 1 study of Hematological Malignancy, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 351 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objective: Phase 1: To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984 (Isatuximab). Phase 2 (stage 1): To evaluate the activity of single-agent Isatuximab at different doses/schedules and to select dose and regimen to further evaluate the overall response rate (ORR) of Isatuximab as single agent or in combination with dexamethasone. Phase 2 (stage 2): To evaluate the activity in terms of overall response rate (ORR) of Isatuximab at the selected dose/schedule from stage1, as single agent (ISA arm) and in combination with dexamethasone (ISAdex arm). Secondary Objectives: Phase 1: * To characterize the global safety profile including cumulative toxicities. * To evaluate the pharmacokinetic (PK) profile of Isatuximab in the proposed dosing schedule(s). * To assess the pharmacodynamics (PD), immune response, and preliminary disease response. Phase 2 (stage 1): to evaluate the following objectives for Isatuximab as single agent: * Safety * Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival. Phase 2 (stage 2): to evaluate the following objectives in each arm (ISA and ISAdex): * Safety * Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival. * Participant-reported changes in health-related quality of life, symptoms of multiple myeloma and generic health status. * Pharmacokinetic profile of Isatuximab. * Immunogenicity of Isatuximab. * Investigate the relationship between CD38 receptor density and CD38 receptor occupancy (Stage 1 only) on multiple myeloma cells and parameters of clinical response.
Primary Outcome
DLTs were assessed using the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03. DLTs were defined as any Grade 3 or higher non-hematological toxicity (with the exception of allergic reaction/hypersensitivity), Grade 4 neutropenia and/or Grade 4 thrombocytopenia lasting longer than 5 days, attributed to isatuximab. Any other toxicity that the Investigator and the Sponsor deemed to be dose-limiting, regardless of the grade, was also considered as DLT
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Isatuximab SAR650984
Study Locations (20)
Buenos Aires
- Investigational Site Number : 032003 - Capital Federal
- Investigational Site Number : 032002 - Ciudad Autonoma de Buenos Aires
- Investigational Site Number : 032001 - Ciudad de Buenos Aires
Michigan
- The University Of Michigan Site Number : 840022 - Ann Arbor
- Karmanos Cancer Center Site Number : 840027 - Detroit
Arizona
- Mayo Clinic Site Number : 840003 - Scottsdale
California
- UCSF MS Center Site Number : 840005 - San Francisco
Georgia
- Emory University Site Number : 840009 - Atlanta
Illinois
- University of Chicago Site Number : 840010 - Chicago
Minnesota
- Mayo Clinic of Rochester Site Number : 840018 - Rochester
Missouri
- Washington University School of Medicine Site Number : 840013 - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 351 participants |
| Start Date | 2010-05-11 |
| Est. Completion | 2023-07-13 |
| Phase | Phase 1 |
What the finished NCT01084252 record still lists
NCT01084252 is an interventional study that assigns participants to a tested intervention. The registered 351 participants enrollment target is mid-sized for trials with a published cap, above the 83-participant average among 9 other Hematological Malignancy trials with a reported enrollment target (323% higher).
The record links to 1 condition, with Hematological Malignancy appearing as the primary indexed condition, and to 2 interventions - of which Dexamethasone is the first listed.
NCT01084252 names 20 study sites across 17 states, led by Buenos Aires, Michigan, Arizona.
Frequently Asked Questions
What is clinical trial NCT01084252 about?
NCT01084252 is a clinical study titled "Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies". Primary Objective: Phase 1: To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984 (Isatuximab). Phase 2 (stage 1): To evaluate the activity of single-agent Isatuximab at different doses/schedules and to select dose and regimen to further evaluate the overall ...
What is the current status of trial NCT01084252?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 351 participants. The study started on 2010-05-11. Estimated completion is 2023-07-13.
What conditions does trial NCT01084252 study?
This clinical trial studies the following conditions: Hematological Malignancy.
What interventions are being tested in trial NCT01084252?
The interventions under investigation include: Dexamethasone (DRUG), Isatuximab SAR650984 (DRUG).
Who is sponsoring clinical trial NCT01084252?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01084252 being conducted?
This trial has 20 study locations across Arizona, California, Georgia, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01084252's enrollment target sits among peer trials
351 2nd of 9 the highest of 9 other Hematological Malignancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hematological Malignancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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