Dose Escalation Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies
This study is currently recruiting participants.
Verified April 2013 by Sanofi
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01084252
First received: March 9, 2010
Last updated: May 7, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Primary Objective:
- To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984
Secondary Objectives:
- To characterize the global safety profile including cumulative toxicities
- To evaluate the pharmacokinetic (PK) profile of SAR650984 in the proposed dosing schedule(s)
- To assess the pharmacodynamics, immune response, and preliminary disease response
| Condition | Intervention | Phase |
|---|---|---|
|
Hematological Malignancy |
Drug: SAR650984 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Dose Escalation Safety and Pharmacokinetic Study of Multiple Intravenous Administrations of a Humanized Monoclonal Antibody (SAR650984) Against CD38 In Patients With Selected CD38+ Hematological Malignancies |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Dose Limiting Toxicities (DLTs) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Safety as assessed from Adverse events reporting, laboratory tests, vital signs according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) version 4.0 grade scaling [ Time Frame: end of treatment + 30days, up to a maximum study duration of 36 months ] [ Designated as safety issue: Yes ]
- Main PK parameters : Partial area under the serum concentration time curve (AUC), maximum observed concentration (Cmax) [ Time Frame: end of treatment + 60 days - PK will be assessed at cycle 1, cycle 2 and at the end of treatment during the accelarated phase and cycle 1,2,3,4 and at the end of treatment during the basic phase ] [ Designated as safety issue: No ]
- Main PD Biomarker : CD38 receptor occupancy [ Time Frame: every 4 weeks up to a maximum duration study duration of 36 months ] [ Designated as safety issue: No ]
- Immune response : levels of human anti-human antibodies [ Time Frame: end of treatment + 60 days ] [ Designated as safety issue: Yes ]
- Preliminary activity assessment with criteria depending on type of hematological malignancies [ Time Frame: every 4 weeks, up to end of treatment + 30days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SAR650984
Accelerated dose escalation phase (1 patient/cohort), two administrations every two weeks (Q2W) per dose cohort. Followed by basic dose escalation phase evaluating SAR650984 administration weekly (QW and Q2W) with 3-6 patients/cohort treated until disease progression or unsatisfactory safety. In each cohort, at least 7 days must pass after dosing the first patient before dosing the second patient. Cohort 1-10 will enroll patients with CD38+ hematological malignancies and cohort 11 onwards will enroll patients with multiple myeloma only.
|
Drug: SAR650984
Pharmaceutical form: solution for infusion Route of administration: intravenous |
Detailed Description:
The study duration for an individual patient will include a period for inclusion of up to 2 weeks, up to 4 weeks of SAR650984 administration (QW, every week or Q2W, every 2 weeks) unless discontinued earlier due to safety or disease progression, followed by a minimum of 30 days following the last use of study drug or more than 30 days in case of unresolved toxicity, or up to initiation of another anticancer treatment.
Patients with Stable Disease (SD), or objective response (complete or partial response : CR, PR) and no Dose Limiting toxicity (DLT) at the end of 4 weeks of SAR650984 dosing may continue treatment (upon investigator's decision) as long as clinical benefit is possible, or until progression (PD) or for other reasons . Patients will be followed by a minimum of 30 days following the last use of study drug or more than 30 days in case of unresolved toxicity, or up to initiation of another anticancer treatment.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Patients with confirmed selected CD38+ hematological malignancies as specified below who have progressed on after standard therapy or for whom there is no effective standard therapy (refractory/relapsed patients).
- B-cell Non-Hodgkin-lymphoma/leukemia (NHL) patients having at least 1 measurable lesion
- Multiple myeloma (MM) patients with measurable M-protein serum and/or 24-hour urine
- Acute myeloid leukemia (AML) patients, all types except M3 based on French-American-British (FAB) classification
- Acute Lymphoblastic Leukemia (B-cell ALL) patient
- Chronic lymphocytic leukemia (CLL) patients
Exclusion criteria:
- Karnofsky performance status <60
- Poor bone marrow reserve
- Poor organ function
- Known intolerance/hypersensitivity to infused protein products
- Any serious active disease (including clinically significant infection that is chronic, recurrent, or active) or co-morbid condition, which, in the opinion of the investigator, could interfere with the safety, the compliance with the study or with the interpretation of the results
- Any severe underlying medical conditions including presence of laboratory abnormalities, which could impair the ability to participate in the study or the interpretation of its results
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084252
Contacts
| Contact: For site information, send an email with site number to | Contact-Us@sanofi.com |
Locations
| United States, Arizona | |
| Investigational Site Number 840003 | Recruiting |
| Scottsdale, Arizona, United States, 85259-5499 | |
| United States, California | |
| Investigational Site Number 840005 | Recruiting |
| San Francisco, California, United States, 94117 | |
| United States, Ohio | |
| Investigational Site Number 840004 | Recruiting |
| Cincinnati, Ohio, United States, 45267-0542 | |
| United States, Tennessee | |
| Investigational Site Number 840001 | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| United States, Utah | |
| Investigational Site Number 840002 | Recruiting |
| Salt Lake City, Utah, United States, 84132-0001 | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01084252 History of Changes |
| Other Study ID Numbers: | TED10893, U1111-1116-5472 |
| Study First Received: | March 9, 2010 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Hematologic Neoplasms Neoplasms by Site Hematologic Diseases |
Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013