Treatment Extension Study for Patients Who Have Previously Participated and Have Benefited From Iniparib in a Clinical Trial

Conditions

• Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Iniparib (SAR240550/BSI-201) — DRUG
  Pharmaceutical form:Solution Route of administration: Intravenous
• Carboplatin — DRUG
  Pharmaceutical form:Solution Route of administration: Intravenous
• Doxorubicin HCL liposome injection — DRUG
  Pharmaceutical form:Solution Route of administration: Intravenous
• Gemcitabine — DRUG
  Pharmaceutical form:Solution Route of administration: Intravenous
• Irinotecan — DRUG
  Pharmaceutical form:Solution Route of administration: Intravenous
• Paclitaxel — DRUG
  Pharmaceutical form:Solution Route of administration: Intravenous
• Topotecan — DRUG
  Pharmaceutical form:Solution Route of administration: Intravenous

Study Details

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.

Key Dates

Start date

May 31, 2012

Status verified

Sep 2017

Primary completion

Sep 30, 2016

Completion

Sep 30, 2016

Study Design

Enrollment

37 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: 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

Primary Outcome Measure

Number of participants with incidence of adverse events by NCI-CTCAE version 4.03 [ Time Frame: Up to 30 days after last treatment dose ]

Locations (29)

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