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ABT-888 and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors

2014-08-27 03:12:31 | BioPortfolio

Summary

RATIONALE: ABT-888 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ABT-888 together with gemcitabine hydrochloride may kill more tumor cells

PURPOSE: This phase I trial is studying the side effects and best dose of giving ABT-888 together with gemcitabine hydrochloride in treating patients with advanced solid tumors.

Description

OBJECTIVES:

Primary

- Establish the maximum-tolerated dose and dose-limiting toxicities of the combination of ABT-888 and gemcitabine hydrochloride in patients with advanced solid tumors.

Secondary

- Establish the safety and tolerability of this regimen in these patients.

- Determine the effects of ABT-888 treatment on the level of PARP inhibition in peripheral blood mononuclear cells (PBMCs).

- Determine the pharmacokinetics of this regimen in these patients.

- Determine the generation of gemcitabine triphosphate in PBMCs.

- Document any evidence of anti-tumor response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study.

Patients receive oral ABT-888 twice daily on days 1-21 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Plasma and peripheral blood mononuclear cells are collected periodically for pharmacokinetic and other laboratory studies.

After completion of study therapy, patients are followed for at least 4 weeks.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

brca1 Mutation Carrier

Intervention

gemcitabine hydrochloride, veliparib, laboratory biomarker analysis, pharmacological study, mutation carrier screening

Location

UPMC Cancer Centers
Pittsburgh
Pennsylvania
United States
15232

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:31-0400

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Medical and Biotech [MESH] Definitions

Laboratory processes prior to specimen analysis. These processes include study design, compliance of the subjects investigated, compliance in adherence to protocols, choice of specimens utilized and sample collection.

Techniques which study entities using their topological, geometric, or geographic properties and include the dimension of time in the analysis.

A type of analysis in which subjects in a study group and a comparison group are made comparable with respect to extraneous factors by individually pairing study subjects with the comparison group subjects (e.g., age-matched controls).

Absolute, comparative, or differential costs pertaining to services, institutions, resources, etc., or the analysis and study of these costs.

A set of techniques used when variation in several variables has to be studied simultaneously. In statistics, multivariate analysis is interpreted as any analytic method that allows simultaneous study of two or more dependent variables.

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