International, Multi-Center, Open-label, Treatment Extension Study of Iniparib as Monotherapy or in Combination Chemotherapeutic Regimens in Cancer Patients Who Have Derived Clinical Benefit From Iniparib Following Completion of a Phase 1, 2 or 3 Parental Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 37
- Locations
- 32
- Primary Endpoint
- Number of participants with incidence of adverse events by NCI-CTCAE version 4.03
Study Overview
Brief Summary
The purpose of this study is to assess the safety and tolerability of iniparib administered as monotherapy or in combination regimens in patients previously treated with iniparib in a clinical study and who have derived clinical benefit after completion of the parental study's objectives.
Detailed Description
The Treatment Extension protocol consists of three time points/periods: the Screening Period (during which assessments are performed to determine whether the patient meets the criteria to participate in the study), the Treatment Period (during which the patient receives treatment with the study drug(s)), and the Post-Treatment Period (during which patients complete an evaluation approximately 30 days after the last dose of study drug). Patients may continue to participate on the Treatment Extension study as long as they meet criteria to continue to receive therapy, tolerate the treatment regimen, do not develop progressive disease (PD), do not discontinue from iniparib, do not withdraw consent, or until iniparib becomes commercially available.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
Patients receiving iniparib alone or in combination with other anti-cancer agents as defined by the parental study. Interventions:
- Drug: Iniparib monotherapy
- Drug: Iniparib + gemcitabine + carboplatin
- Drug: Iniparib + topotecan
- Drug: Iniparib + irinotecan
- Drug: Iniparib + paclitaxel
- Drug: Iniparib + liposomal doxorubicin + carboplatin
Intervention: Iniparib (SAR240550/BSI-201) (Drug)
1
Patients receiving iniparib alone or in combination with other anti-cancer agents as defined by the parental study. Interventions:
- Drug: Iniparib monotherapy
- Drug: Iniparib + gemcitabine + carboplatin
- Drug: Iniparib + topotecan
- Drug: Iniparib + irinotecan
- Drug: Iniparib + paclitaxel
- Drug: Iniparib + liposomal doxorubicin + carboplatin
Intervention: Carboplatin (Drug)
1
Patients receiving iniparib alone or in combination with other anti-cancer agents as defined by the parental study. Interventions:
- Drug: Iniparib monotherapy
- Drug: Iniparib + gemcitabine + carboplatin
- Drug: Iniparib + topotecan
- Drug: Iniparib + irinotecan
- Drug: Iniparib + paclitaxel
- Drug: Iniparib + liposomal doxorubicin + carboplatin
Intervention: Doxorubicin HCL liposome injection (Drug)
1
Patients receiving iniparib alone or in combination with other anti-cancer agents as defined by the parental study. Interventions:
- Drug: Iniparib monotherapy
- Drug: Iniparib + gemcitabine + carboplatin
- Drug: Iniparib + topotecan
- Drug: Iniparib + irinotecan
- Drug: Iniparib + paclitaxel
- Drug: Iniparib + liposomal doxorubicin + carboplatin
Intervention: Gemcitabine (Drug)
1
Patients receiving iniparib alone or in combination with other anti-cancer agents as defined by the parental study. Interventions:
- Drug: Iniparib monotherapy
- Drug: Iniparib + gemcitabine + carboplatin
- Drug: Iniparib + topotecan
- Drug: Iniparib + irinotecan
- Drug: Iniparib + paclitaxel
- Drug: Iniparib + liposomal doxorubicin + carboplatin
Intervention: Irinotecan (Drug)
1
Patients receiving iniparib alone or in combination with other anti-cancer agents as defined by the parental study. Interventions:
- Drug: Iniparib monotherapy
- Drug: Iniparib + gemcitabine + carboplatin
- Drug: Iniparib + topotecan
- Drug: Iniparib + irinotecan
- Drug: Iniparib + paclitaxel
- Drug: Iniparib + liposomal doxorubicin + carboplatin
Intervention: Paclitaxel (Drug)
1
Patients receiving iniparib alone or in combination with other anti-cancer agents as defined by the parental study. Interventions:
- Drug: Iniparib monotherapy
- Drug: Iniparib + gemcitabine + carboplatin
- Drug: Iniparib + topotecan
- Drug: Iniparib + irinotecan
- Drug: Iniparib + paclitaxel
- Drug: Iniparib + liposomal doxorubicin + carboplatin
Intervention: Topotecan (Drug)
Outcomes
Primary Outcomes
Number of participants with incidence of adverse events by NCI-CTCAE version 4.03
Time Frame: Up to 30 days after last treatment dose
Secondary Outcomes
No secondary outcomes reported