Trials / Completed
CompletedNCT00687687
Evaluation of Paclitaxel (Taxol, NSC #673089), Carboplatin (Paraplatin, NSC #241240), and BSI-201 (NSC #746045, IND #71,677) in the Treatment of Advanced, Persistent, or Recurrent Uterine Carcinosarcoma
A Phase II Evaluation of Paclitaxel (Taxol, NSC #673089), Carboplatin (Paraplatin, NSC #241240), and BSI-201 (NSC #746045, IND #71,677) in the Treatment of Advanced, Persistent, or Recurrent Uterine Carcinosarcoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To estimate the antitumor activity of paclitaxel, carboplatin, plus BSI-201 in patients with recurrent or advanced uterine carcinosarcomas. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | paclitaxel | Paclitaxel will be administered IV over 3 hours on Day 1 every 21 days. |
| DRUG | carboplatin | Carboplatin will be administered intravenously (IV) over 30 minutes on day 1 after pacitaxel administration, every 21 days. |
| DRUG | BSI-201 (Iniparib) | BSI-201 will be administered IV over one hour twice weekly beginning on day 1 (doses of BSI-201 must be separated by at least 2 days). |
Timeline
- Start date
- 2008-05-01
- Primary completion
- 2010-03-01
- Completion
- 2011-12-01
- First posted
- 2008-06-02
- Last updated
- 2012-08-07
Locations
40 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00687687. Inclusion in this directory is not an endorsement.