Merkel Cell Carcinoma Clinical Trial
Official title:
A Phase 1 Study of Veliparib (ABT-888) in Combination With Capecitabine and Temozolomide in Advanced Well-Differentiated Neuroendocrine Tumors
This phase I trial studies the side effects and best dose of veliparib when given together with capecitabine and temozolomide in treating patients with neuroendocrine tumor that has spread to other places in the body and usually cannot be cured or controlled with treatment, has returned after a period of improvement, and cannot be removed by surgery. 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 temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of veliparib (ABT-888) in combination with
capecitabine and temozolomide in patients with advanced well-differentiated neuroendocrine
tumors.
SECONDARY OBJECTIVES:
2. To determine the safety profile of the combination of capecitabine, temozolomide and
veliparib in patients with advanced well-differentiated neuroendocrine tumors (NET).
3. To evaluate the antitumor activity of the combination of capecitabine, temozolomide and
veliparib in advanced well-differentiated NET patients
4. To determine progression-free survival (PFS) of the combination of capecitabine,
temozolomide, and veliparib in advanced well-differentiated NET patients IV. To evaluate the
association between pharmacodynamic biomarkers and response in patients with advanced
well-differentiated NET patients.
OUTLINE: This is a dose-escalation study of veliparib.
Patients receive capecitabine orally (PO) twice daily (BID) on days 1-14, temozolomide PO BID
on days 10-14 and veliparib PO BID on days 10-14. Courses repeat every 28 days for up to 12
courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
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