A Study Evaluating BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00422682
First received: January 12, 2007
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

The purpose of the study is to assess the safety and establish the maximum tolerated dose (MTD) of the combination of BSI-201 with chemotherapeutic regimens in adult subjects with histologically or cytologically documented advanced solid tumors.

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
Tumors
Drug: bsi-201 + topotecan
Drug: bsi-201 + temozolomide
Drug: bsi-201 + gemcitabine
Drug: bsi-201 + carboplatin/paclitaxel
Phase 1

Access to an investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1B, Open-Label, Dose Escalation Study Evaluating the Safety of BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • safety and efficacy [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
  • Response rate (CR + PR) [ Time Frame: every 2 cycles ] [ Designated as safety issue: No ]

Enrollment: 136
Study Start Date: January 2007
Study Completion Date: September 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
BSI-201 + topotecan
Drug: bsi-201 + topotecan
21 day cycle
Experimental: 2
BSI-201 + temozolomide
Drug: bsi-201 + temozolomide
28 day cycle
Experimental: 3
bsi-201 + gemcitabine
Drug: bsi-201 + gemcitabine
28 day cycle
Experimental: 4
bsi-201 + carboplatin/paclitaxel
Drug: bsi-201 + carboplatin/paclitaxel
21 day cycle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 years old with a histologically or cytologically documented, advanced solid tumor
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (without granulocyte colony-stimulating factor [G-CSF] support within 2 weeks of study day 1); platelet count ≥ 100.0 x 10^9/L (without transfusion within 2 weeks of study day 1); and hemoglobin ≥ 9.0 g/dL (erythropoietic agents allowed)
  • At least a 14-day period from end of last dose of chemotherapy received
  • Any prior toxicity from prior chemotherapeutic treatment recovered to ≤ grade 1

Exclusion Criteria:

  • Subject enrolled in another investigational device or drug trial, or is receiving other investigational agents
  • Hematological malignancies
  • Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids.
  • History of seizure disorder
  • Myocardial infarction (MI) within 6 months of study day 1, unstable angina, congestive heart failure (CHF) with New York Heart Association (NYHA) > class II, or uncontrolled hypertension
  • Concurrent or prior (within 7 days of study day 1) anticoagulation therapy (low dose for port maintenance allowed)
  • Specified concomitant medications
  • Serum creatinine > 1.5 x upper limit of normal (ULN)
  • Elevated liver enzymes (AST/ALT) > 2.5 x ULN, or > 5.0 x ULN if secondary to liver metastases; alkaline phosphatase > 2.5 x ULN or > 5.0 x ULN if secondary to liver or bone metastases; total bilirubin > 1.5 x ULN
  • Radiation therapy within 14 days of study day 1
  • Antibody therapy for the treatment of an underlying malignancy within 14 days of study day 1
  • Concurrent radiation therapy is not permitted throughout the course of the study
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422682

Locations
United States, Connecticut
Research Site
New Haven, Connecticut, United States
United States, Michigan
Research Site
Detroit, Michigan, United States
United States, New York
Research Site
New York City, New York, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, Texas
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Sponsors and Collaborators
Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00422682     History of Changes
Other Study ID Numbers: TCD11484, 20060102
Study First Received: January 12, 2007
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Solid tumors

Additional relevant MeSH terms:
Neoplasms
Carboplatin
Gemcitabine
Paclitaxel
Temozolomide
Topotecan
Alkylating Agents
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on October 29, 2014