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NCT01455532 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation Study of Iniparib as a Single Agent and in Combination in Solid Tumors
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
NCT01455532 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 59 participants.
The verdict
NCT01455532, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
Study Summary
Primary Objective: * To assess the safety and the maximum tolerated dose(MTD) of iniparib as a single agent and in combination with chemotherapeutic regimens in patients with advanced solid tumors that are refractory to standard therapy. Secondary Objectives: * To assess the antitumor effect of iniparib (per Response Evaluation Criteria in Solid Tumors \[RECIST\]) Version 1.1 in patients with measurable disease. * To characterize iniparib (and its metabolites, if possible) pharmacokinetics. Based on data generated by 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.
Interventions
- DRUG Carboplatin
- DRUG Gemcitabine
- DRUG Pegylated liposomal doxorubicin
- DRUG Iniparib (SAR240550-BSI-201)
- DRUG Placlitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2011-11 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01455532
The ClinicalTrials.gov registry entry for NCT01455532 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT01455532 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01455532 about?
NCT01455532 is a clinical study titled "A Dose Escalation Study of Iniparib as a Single Agent and in Combination in Solid Tumors". Primary Objective: * To assess the safety and the maximum tolerated dose(MTD) of iniparib as a single agent and in combination with chemotherapeutic regimens in patients with advanced solid tumors that are refractory to standard therapy. Secondary Objectives: * To assess the antitumor effect of i...
What is the current status of trial NCT01455532?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2011-11. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01455532?
The interventions under investigation include: Carboplatin (DRUG), Gemcitabine (DRUG), Pegylated liposomal doxorubicin (DRUG), Iniparib (SAR240550-BSI-201) (DRUG), Placlitaxel (DRUG).
Who is sponsoring clinical trial NCT01455532?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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