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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Sanofi
Study ID
NCT00298675
Phase
PHASE1
Status
Completed

Conditions

  • Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BSI-201 (iniparib) — DRUG
    BSI-201 administered intravenously (IV), 2x weekly
  • irinotecan — DRUG
    Irinotecan administered weekly, IV.

Study Details

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.

Key Dates

Start date
Mar 31, 2006
Status verified
Aug 2012
Primary completion
Jul 31, 2010
Completion
May 31, 2011

Study Design

Enrollment
59 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Iniparib
  • Experimental: Iniparib/irinotecan

Primary Outcome Measure

Maximum tolerated dose [ Time Frame: After one cycle ]

Locations (3)

FacilityCityStateZIPSite coordinators
Research SiteNew HavenConnecticut--
Research SiteHoustonTexas--
Research SiteSan AntonioTexas--

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