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Safety and Pharmacokinetics of SAR240550 (BSI-201) Twice Weekly in Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01213381
First Posted: October 4, 2010
Last Update Posted: May 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
  Purpose

Primary Objective:

- To determine a dose of SAR240550 to be further studied in combination with chemotherapy regimens

Secondary Objectives:

  • To determine the dose limiting toxicity (DLT) of SAR240550 and SAR240550 in combination with chemotherapy regimen (gemcitabine and carboplatin
  • To assess safety profiles: significant laboratory changes and adverse events (AEs)
  • To make a preliminary assessment of antitumor effect in study subjects per Response Evaluation Criteria in Solid Tumors (RECIST) with measurable disease
  • To characterize SAR240550 and metabolites, 4-iodo-3-amino benzamide (IABM) and 4-iodo-3-amino-benzoic acid (IABA), pharmacokinetics
  • To collect blood samples for glutathione S-transferase (GST) genotypes at baseline)

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.


Condition Intervention Phase
Advance Solid Tumors Drug: Iniparib (SAR240550 - BSI-201) Drug: Gemcitabine Drug: Carboplatin Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study Evaluating the Safety and Pharmacokinetics of SAR240550 Administered Twice Weekly in Patients With Advanced Solid Tumors.

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Dose Limiting Toxicity in cycle 1 [ Time Frame: 3 Weeks ]

Secondary Outcome Measures:
  • Efficacy assessment as tumor response defined by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 30 days after the last injection ]
  • Safety based on clinical and laboratory tests and Adverse Events (AEs) [ Time Frame: 30 days after the last injection ]
  • Pharmacokinetics of SAR240550 [ Time Frame: Cycle 1 and Cycle 2 ]
  • Pharmacodynamics of SAR240550 [ Time Frame: Cycle1, Cycle 2 and 30 days after the last injection ]
  • Pharmacogenomic analysis of glutathione S-transferase (GST) genotypes [ Time Frame: Cycle 1 ]

Enrollment: 18
Study Start Date: September 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAR240550
  • single cohort: SAR240550
  • combination cohort: SAR240550 in combination with Gemcitabine and Carboplatin
Drug: Iniparib (SAR240550 - BSI-201)

Pharmaceutical form:sterile aqueous solution

Route of administration: intravenous

Drug: Gemcitabine

Pharmaceutical form:sterile aqueous solution

Route of administration: intravenous

Drug: Carboplatin

Pharmaceutical form:sterile aqueous solution

Route of administration: intravenous


Detailed Description:
The duration of the study for each patient will include an up to 4-week screening phase, 21-day study cycle(s), followed by a 30 day follow-up.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

- Histologically or cytologically documented advanced solid tumor that was refractory to standard therapy or for which no standard therapy is available

Exclusion criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of ≥2
  • Known hematological malignancies
  • Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids
  • Myocardial infarction within 6 months of study Day 1, unstable angina, congestive heart failure with New York Heart Association >class II, uncontrolled hypertension
  • Active human immunodeficiency virus infection, hepatitis C virus, or chronic hepatitis B infection
  • Major surgery within 28 days of study Day 1
  • Not recovered from all previous therapies (i.e. radiation, surgery, and medications)
  • Adverse events related to previous therapies must be Common Terminology Criteria for Adverse Events (CTCAE) grade ≤ 1 (except alopecia) at screening or returned to the subject's baseline prior to their most recent previous therapy
  • Inadequate organ and bone marrow function Radiation therapy within 14 days of study Day 1
  • Chemotherapy or antibody therapy for treatment of underlying malignancy within 21 days of study Day 1
  • Concurrent or prior (within 7 days of study Day 1) anticoagulation therapy
  • Currently enrolled or was enrolled within 30 days of completing other investigational drug study, or receiving other investigational agent not approved for any indications
  • Subject who had been previously enrolled in this study . Not available for follow-up assessment
  • Any kind of disorder that compromised the ability of the subject to give written informed consent and/or comply with the study procedures
  • Patient who is judged by the investigator as not suitable for participation in the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Information from the National Library of Medicine

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): NCT01213381


Locations
Japan
Sanofi-Aventis Investigational Site Number 392001
Kobe-Shi, Japan
Sanofi-Aventis Investigational Site Number 392002
Matsuyama-Shi, Japan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01213381     History of Changes
Other Study ID Numbers: TED11451
U1111-1117-3152 ( Other Identifier: UTN )
First Submitted: September 30, 2010
First Posted: October 4, 2010
Last Update Posted: May 24, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Gemcitabine
Iniparib
Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Poly(ADP-ribose) Polymerase Inhibitors