Treatment Extension Study for Patients Who Have Previously Participated and Have Benefited From Iniparib in a Clinical Trial
- Conditions
- Solid Tumors
- Interventions
- Registration Number
- NCT01593228
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Carboplatin 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 1 Iniparib (SAR240550/BSI-201) 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 1 Doxorubicin HCL liposome injection 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 1 Gemcitabine 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 1 Irinotecan 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 1 Paclitaxel 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 1 Topotecan 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
- Primary Outcome Measures
Name Time Method Number of participants with incidence of adverse events by NCI-CTCAE version 4.03 Up to 30 days after last treatment dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
Investigational Site Number 840013
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 840033
🇺🇸Santa Maria, California, United States
Investigational Site Number 840046
🇺🇸Vallejo, California, United States
Investigational Site Number 840008
🇺🇸Denver, Colorado, United States
Investigational Site Number 840027
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 840063
🇺🇸Augusta, Georgia, United States
Investigational Site Number 840055
🇺🇸Tucker, Georgia, United States
Investigational Site Number 840039
🇺🇸Maywood, Illinois, United States
Investigational Site Number 840012
🇺🇸Indianapolis, Indiana, United States
Investigational Site Number 840025
🇺🇸Sioux City, Iowa, United States
Scroll for more (22 remaining)Investigational Site Number 840013🇺🇸Birmingham, Alabama, United States