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.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00298675
First received: March 1, 2006
Last updated: August 1, 2012
Last verified: August 2012

March 1, 2006
August 1, 2012
March 2006
July 2010   (final data collection date for primary outcome measure)
Maximum tolerated dose [ Time Frame: After one cycle ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00298675 on ClinicalTrials.gov Archive Site
Clinical Response [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid Tumors
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Tumors
  • Drug: BSI-201 (iniparib)
    BSI-201 administered intravenously (IV), 2x weekly
    Other Name: SAR240550
  • Drug: irinotecan
    Irinotecan administered weekly, IV.
  • Experimental: Iniparib
    Intervention: Drug: BSI-201 (iniparib)
  • Experimental: Iniparib/irinotecan
    Interventions:
    • Drug: BSI-201 (iniparib)
    • Drug: irinotecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
May 2011
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00298675
TED11483, 20060101
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP