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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Hematological Malignancy

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose Limiting Toxicities (DLTs)

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

TED10893

NCT ID:

NCT01084252

Start Date:

June 2010

Completion Date:

March 2014

Related Keywords:

  • Hematological Malignancy
  • Neoplasms
  • Hematologic Neoplasms

Name

Location

Investigational Site Number 840001Nashville, Tennessee  37232
Investigational Site Number 840003Scottsdale, Arizona  85259-5499
Investigational Site Number 840005San Francisco, California  94117
Investigational Site Number 840004Cincinnati, Ohio  45267-0542
Investigational Site Number 840002Salt Lake City, Utah  84132-0001