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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.
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.
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.
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Estrogen Receptor-negative Breast Cancer
immunohistochemistry staining method, gene expression analysis, ABT-888, cisplatin, vinorelbine ditartrate, pharmacological study, laboratory biomarker analysis
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Not yet recruiting
Fred Hutchinson Cancer Research Center
Published on BioPortfolio: 2014-08-27T03:14:34-0400
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MOLECULAR BIOLOGY techniques used in the diagnosis of disease. Included are such techniques as IN SITU HYBRIDIZATION of chromosomes for CYTOGENETIC ANALYSIS; OLIGONUCLEOTIDE ARRAY SEQUENCE ANALYSIS of gene expression patterns in disease states; identification of pathogenic organisms by analysis of species specific DNA sequences; and detection of mutations with POLYMERASE CHAIN REACTION.
The expression of a gene in an abnormal place, or at an abnormal time in an organism. Ectopic Gene Expression is often induced artificially by genetic techniques.
A form of gene interaction whereby the expression of one gene interferes with or masks the expression of a different gene or genes. Genes whose expression interferes with or masks the effects of other genes are said to be epistatic to the effected genes. Genes whose expression is affected (blocked or masked) are hypostatic to the interfering genes.
A method of chemical analysis based on the detection of characteristic radionuclides following a nuclear bombardment. It is also known as radioactivity analysis. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)
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In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...