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ABT-888, Cisplatin, and Vinorelbine Ditartrate in Treating Patients With Recurrent and/or Metastatic Breast Cancer

2014-08-27 03:14:34 | BioPortfolio

Summary

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

PURPOSE: This phase I trial is studying the side effects and best dose of ABT-888 when given together with cisplatin and vinorelbine ditartrate in treating patients with recurrent and/or metastatic breast cancer.

Description

PRIMARY OBJECTIVES:

I. The primary objective of the study is to determine the MTD of ABT-888 when administered daily for 14 days out of a 21 day cycle in combination with cisplatin and vinorelbine in subjects with metastatic TNBC and BRCA mutation associated breast cancer.

SECONDARY OBJECTIVES:

I. Assess the pharmacokinetic profile of ABT-888 when combined with cisplatin and vinorelbine and the safety/tolerability profile of the combination.

II. Evaluate the level of PARP inhibition at each dose level to determine whether maximal PARP inhibition is achieved.

III. Identify the subgroup of triple negative breast cancer patients who will potentially derive the most benefits from PARP inhibition combined with platinum-based chemotherapy.

OUTLINE:

This is a dose-escalation study of ABT-888.

Patients receive oral ABT-888 twice daily on days 1-14 (days 0-13 of course 1 only). Patients also receive cisplatin IV over 1 hour on day 1 and vinorelbine ditartrate IV over 5-10 minutes on days 1 and 8. Treatment repeats every 21 days for 6- 10 courses in the absence of disease progression or unacceptable toxicity. Treatment with ABT-888 alone may continue in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for up to 30 days.

Study Design

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

Conditions

Estrogen Receptor-negative Breast Cancer

Intervention

immunohistochemistry staining method, gene expression analysis, ABT-888, cisplatin, vinorelbine ditartrate, pharmacological study, laboratory biomarker analysis

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle
Washington
United States
19024-1024

Status

Not yet recruiting

Source

Fred Hutchinson Cancer Research Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:34-0400

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