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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 37
- 试验地点
- 32
- 主要终点
- Number of participants with incidence of adverse events by NCI-CTCAE version 4.03
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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
干预措施: 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
干预措施: 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
干预措施: 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
干预措施: 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
干预措施: 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
干预措施: 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
干预措施: Topotecan (Drug)
结局指标
主要结局
Number of participants with incidence of adverse events by NCI-CTCAE version 4.03
时间窗: Up to 30 days after last treatment dose
次要结局
未报告次要终点