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A Dose Escalation Study of Iniparib as a Single Agent and in Combination in Solid Tumors

NCT01455532 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2014-10-22

No results posted yet for this study

Summary

Primary Objective:

* To assess the safety and the maximum tolerated dose(MTD) of iniparib as a single agent and in combination with chemotherapeutic regimens in patients with advanced solid tumors that are refractory to standard therapy.

Secondary Objectives:

* To assess the antitumor effect of iniparib (per Response Evaluation Criteria in Solid Tumors \[RECIST\]) Version 1.1 in patients with measurable disease.
* To characterize iniparib (and its metabolites, if possible) pharmacokinetics.

Based on data generated by Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

Conditions

  • Neoplasm Malignant

Interventions

DRUG

Iniparib (SAR240550-BSI-201)

Pharmaceutical form:Solution for infusion Route of administration: Intravenous

DRUG

Gemcitabine

Pharmaceutical form:Solution for infusion Route of administration: Intravenous

DRUG

Carboplatin

Pharmaceutical form:Solution for infusion Route of administration: Intravenous

DRUG

Placlitaxel

Pharmaceutical form:Solution for infusion Route of administration: Intravenous

DRUG

Pegylated liposomal doxorubicin

Pharmaceutical form:Solution for infusion Route of administration: Intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-05-31
Completion
2014-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01455532 on ClinicalTrials.gov