An Open-label Study Investigating the Disposition and QT/QTc Interval Effects of 400 mg [14C]-Iniparib(3.7 MBq, 100 µCi)

Sanofi

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: Iniparib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01161836

BEX11505

20100109 (Other Identifier)

Details and patient eligibility

About

This is a Phase 1, multi-center, open-label study.

During Segment 1, patients are administered a single IV administration of [14C]-iniparib.

During Segment 2, patients are administered iniparib with or without additional chemotherapy. Acceptable chemotherapy regimens is limited to those for which previous experience with iniparib exists.

Enrollment: 7 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Male or female patients with advanced solid tumors that are refractory to standard treatment or for which no standard treatment exists; patients must be at least 18 years old.

Additional criteria are also required and should be evaluated by the research staff.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

iniparib

Experimental group

Description:

Segment 1: 400 mg \[14C\]-iniparib single administration Segment 2: Iniparib, 5.6mg/kg, extension treatment with or without additional chemotherapy

Treatment:

Drug: Iniparib