A Phase I Study Evaluating the Safety and Pharmacokinetics of SAR240550 Administered Twice Weekly in Patients With Advanced Solid Tumors.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Dose Limiting Toxicity in cycle 1
Study Overview
Brief Summary
Primary Objective:
- To determine a dose of SAR240550 to be further studied in combination with chemotherapy regimens
Secondary Objectives:
- To determine the dose limiting toxicity (DLT) of SAR240550 and SAR240550 in combination with chemotherapy regimen (gemcitabine and carboplatin
- To assess safety profiles: significant laboratory changes and adverse events (AEs)
- To make a preliminary assessment of antitumor effect in study subjects per Response Evaluation Criteria in Solid Tumors (RECIST) with measurable disease
- To characterize SAR240550 and metabolites, 4-iodo-3-amino benzamide (IABM) and 4-iodo-3-amino-benzoic acid (IABA), pharmacokinetics
- To collect blood samples for glutathione S-transferase (GST) genotypes at baseline)
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.
Detailed Description
The duration of the study for each patient will include an up to 4-week screening phase, 21-day study cycle(s), followed by a 30 day follow-up.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
SAR240550
- single cohort: SAR240550
- combination cohort: SAR240550 in combination with Gemcitabine and Carboplatin
Intervention: Iniparib (SAR240550 - BSI-201) (Drug)
SAR240550
- single cohort: SAR240550
- combination cohort: SAR240550 in combination with Gemcitabine and Carboplatin
Intervention: Gemcitabine (Drug)
SAR240550
- single cohort: SAR240550
- combination cohort: SAR240550 in combination with Gemcitabine and Carboplatin
Intervention: Carboplatin (Drug)
Outcomes
Primary Outcomes
Dose Limiting Toxicity in cycle 1
Time Frame: 3 Weeks
Secondary Outcomes
- Efficacy assessment as tumor response defined by Response Evaluation Criteria in Solid Tumors (RECIST)(30 days after the last injection)
- Safety based on clinical and laboratory tests and Adverse Events (AEs)(30 days after the last injection)
- Pharmacokinetics of SAR240550(Cycle 1 and Cycle 2)
- Pharmacodynamics of SAR240550(Cycle1, Cycle 2 and 30 days after the last injection)
- Pharmacogenomic analysis of glutathione S-transferase (GST) genotypes(Cycle 1)