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Dose-Escalation, Safety, Pharmacokinetics Study of Cabazitaxel With Gemcitabine In Patients With Solid Tumor

2014-07-23 21:12:18 | BioPortfolio

Summary

Primary Objectives:

- Part 1: To determine the Maximum Tolerated Dose (MTD) and the Dose Limiting Toxicities (DLTs) of cabazitaxel administered as a 1-hour infusion in combination with gemcitabine, every 3 weeks in patients with advanced solid malignancies.

- Part 2: To determine the antitumor activity of cabazitaxel in combination with gemcitabine, in an additional extended cohort of 15 patients with advanced solid malignancies treated with the defined MTD, as assessed by objective response rate (ORR) according to the revised guideline for Response Evaluation Criteria in Solid Tumours (RECIST 1.1 criteria).

Secondary Objectives:

- To assess the safety profile of the combination regimen of cabazitaxel with gemcitabine.

- To assess the pharmacokinetics (PK) of cabazitaxel, gemcitabine and its metabolite, and 2,2 difluoridine when given in combination.

- To determine Time to Progression (TTP), Objective Response Rate (ORR), and Duration of Response (DR), in the extended cohort of patients treated at the MTD in Part 2 of the study and the patients who received the MTD in Part 1 component.

- To assess the potential inhibitory effect of cabazitaxel on CYP3A4 using midazolam, a CYP3A4 probe since cabazitaxel inhibits CYP3A4 in vitro.

Description

The study consists of a screening phase (maximum length of 21-day), a treatment phase with 21-day study treatment cycles. Cycle lengths may be extended up to maximum of 2 additional weeks in case of unresolved toxicity. Patients will be treated until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision.There will be a 30-day follow-up visit after the last dose of study medication. Patients who discontinue study treatment prior to disease progression will continue to have tumor assessments every 6 weeks until disease progression or start of an other anticancer therapy.

The cut off date for the study is defined as follows: all patients will be followed up until disease progression, unacceptable toxicity, consent withdrawal or when the last patient had completed 26 weeks or 6 cycles on study treatment, whichever comes first. Patients may continue to be treated on study as long as they are benefiting from study treatment and have not met study withdrawal criteria. After withdrawal from study treatment, further treatment, if any, is at the discretion of the Investigator.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Neoplasms, Malignant

Intervention

cabazitaxel (XRP6258), gemcitabine, midazolam

Location

Sanofi-Aventis Investigational Site Number 840002
Detroit
Michigan
United States
48201

Status

Recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:12:18-0400

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