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Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid Tumors

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: March 1, 2006
Last updated: August 1, 2012
Last verified: August 2012

The purpose of this study is to assess the safety, establish the maximum tolerated dose (MTD) and generate pharmacokinetic profiles of BSI-201 after IV administration in adult subjects with histologically documented advanced solid tumors that are refractory to standard therapy or for which no standard therapy is available. Additionally, the safety and tolerability and clinical response of BSI-201 + irinotecan will be investigated in patients with metastatic breast cancer in the phase 1b portion of the study.

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
Drug: BSI-201 (iniparib)
Drug: irinotecan
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 Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid Tumors

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: After one cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical Response [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: March 2006
Study Completion Date: May 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iniparib Drug: BSI-201 (iniparib)
BSI-201 administered intravenously (IV), 2x weekly
Other Name: SAR240550
Experimental: Iniparib/irinotecan Drug: BSI-201 (iniparib)
BSI-201 administered intravenously (IV), 2x weekly
Other Name: SAR240550
Drug: irinotecan
Irinotecan administered weekly, IV.


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

Inclusion Criteria:

  • Pathologically documented, advanced solid tumor that is refractory to standard therapy or for which no standard therapy is available.
  • ECOG performance status of 0, 1, or 2
  • Adequate hematological status
  • Any prior toxicity from prior chemotherapeutic treatment recovered to grade 1 or grade 0
  • 18 years of age or older
  • Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved informed consent form
  • For phase 1b portion only: metastatic breast cancer

Exclusion Criteria:

  • Hematologic 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 NYHA > class II, uncontrolled hypertension
  • Known positive test for HIV or hepatitis C virus, or chronic active hepatitis
  • Major surgery within 1 month of study day 1
  • History of second neoplasm, except for curatively treated non-melanoma skin cancer, carcinoma in situ of the cervix and other primary cancer with no known active disease present and no curative treatment administered for the last 3 years
  • History of seizure disorder or currently on anti-seizure medication
  • Systemic chemotherapy or radiation therapy within 28 days of study day 1
  • Antibody therapy for treatment of underlying malignancy within 1 month of study day 1
  • Evidence of liver disease shown by elevated enzymes
  • Evidence of renal disease shown by serum creatinine > 1.5 x upper limit of normal
  • Currently receiving platelet of GCF support for any medical condition
  • Concurrent use of herbal medications taken with the intent to treat cancer
  • Enrolled in or not yet completed at least 30 days since ending other investigational device or drug 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 identifier: NCT00298675

United States, Connecticut
Research Site
New Haven, Connecticut, United States
United States, Texas
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi Identifier: NCT00298675     History of Changes
Other Study ID Numbers: TED11483, 20060101
Study First Received: March 1, 2006
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors processed this record on February 26, 2015