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A Phase 1/1b Dose Escalation Study Evaluating Iniparib (BSI201/SAR240550) as a Single Agent and in Combination With Chemotherapeutic Regimens in Patients With Solid Tumors

Study identifier: NCT01455532
Full study details on clinicaltrials.gov

Name of investigational agent used in study:

Iniparib (Sanofi)


Advanced and/or metastatic cancer that does not respond to standard therapy or for which no standard therapy exists

Type of study:

Phase I study


Participants are assigned to one of 4 groups:

  1. A 21-day cycle with Iniparib intravenously on days 1, 8, and 15, followed by a 21-day cycle with Iniparib intravenously on days 1, 4, 8, 15, and 18.
  2. 21-day cycles with gemcitabine/carboplatin on days 1 and 8, and iniparib intravenously on days 1 and 8 OR days 1, 4, 8, and 11
  3. 28-day cycles with Paclitaxel on days 1, 8, and 15 and iniparib intravenously on days 1, 8, and 15 OR days 1, 4, 8, 11, 15 and 18.
  4. 28-day cycles with Doxil and carboplatin on day 1 and iniparib intravenously on days 1 and 8 OR days 1, 4, 8, and 11

Study sites:

Contact: For information on any study site, send an email with site number to Contact-Us@sanofi.com

Investigational Site Number 840002

Los Angeles
Investigational Site Number 840004

Investigational Site Number 840010

St. Louis
Investigational Site Number 840007

Investigational Site Number 840001

San Antonio
Investigational Site Number 840006

Page updated 06/13/13

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