NCT01233505

Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors

A Phase I Study of ABT-888 in Combination With Oxaliplatin and Capecitabine in Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial is studying the side effects and the best dose of veliparib when given together with capecitabine and oxaliplatin in treating patients with advanced solid tumors. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving veliparib together with capecitabine and oxaliplatin may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To determine the dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD) of ABT-888 (veliparib) in combination with oxaliplatin and capecitabine in advanced solid tumors. SECONDARY OBJECTIVES: I. To evaluate the pharmacokinetics of ABT-888, oxaliplatin, and capecitabine when administered concomitantly. II. To evaluate the safety and tolerability of the ABT-888 in combination with capecitabine and oxaliplatin. III. To assess for evidence of anti-tumor activity with this combination, per tumor measurements using RECIST criteria, in these patients. TERTIARY OBJECTIVES: I. To assess the inhibition of poly(ADP-ribose) polymerase (PARP) in peripheral blood mononuclear cells secondary to treatment with ABT-888. II. To determine the pharmacokinetics of ABT-888 in combination with oxaliplatin and capecitabine and the relation to treatment side effects. OUTLINE: This is a dose-escalation study of veliparib. Patients receive veliparib orally (PO) twice daily and capecitabine PO twice daily on 1-7 and 15-21, and oxaliplatin intravenously (IV) over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood and urine sample collection at baseline and periodically during study for pharmacokinetic and poly (ADP-ribose) polymerase (PARP) inhibition studies. After completion of study therapy, patients are followed up for 30 days.

Conditions

• Adenocarcinoma of the Pancreas
• Adenocarcinoma of the Stomach
• BRCA1 Mutation Carrier
• BRCA2 Mutation Carrier
• Ovarian Mucinous Cystadenocarcinoma
• Recurrent Breast Cancer
• Recurrent Colon Cancer
• Recurrent Gastric Cancer
• Recurrent Ovarian Epithelial Cancer
• Recurrent Ovarian Germ Cell Tumor
• Recurrent Pancreatic Cancer
• Recurrent Rectal Cancer
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer
• Stage IV Breast Cancer
• Stage IV Colon Cancer
• Stage IV Gastric Cancer
• Stage IV Ovarian Epithelial Cancer
• Stage IV Ovarian Germ Cell Tumor
• Stage IV Pancreatic Cancer
• Stage IV Rectal Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	veliparib	Given PO
DRUG	capecitabine	Given PO
DRUG	oxaliplatin	Given IV
OTHER	pharmacological study	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-10-01
• First posted: 2010-11-03
• Last updated: 2014-04-02

Locations

1 site across 1 country: United States