NCT02831179

Veliparib, Capecitabine, and Temozolomide in Patients With Advanced, Metastatic, and Recurrent Neuroendocrine Tumor

A Phase 1 Study of Veliparib (ABT-888) in Combination With Capecitabine and Temozolomide in Advanced Well-Differentiated Neuroendocrine Tumors

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Functional Pancreatic Neuroendocrine Tumor
• Malignant Somatostatinoma
• Merkel Cell Carcinoma
• Metastatic Adrenal Gland Pheochromocytoma
• Metastatic Carcinoid Tumor
• Multiple Endocrine Neoplasia Type 1
• Multiple Endocrine Neoplasia Type 2A
• Multiple Endocrine Neoplasia Type 2B
• Neuroendocrine Neoplasm
• Non-Functional Pancreatic Neuroendocrine Tumor
• Pancreatic Glucagonoma
• Pancreatic Insulinoma
• Recurrent Adrenal Cortex Carcinoma
• Recurrent Adrenal Gland Pheochromocytoma
• Recurrent Merkel Cell Carcinoma
• Somatostatin-Producing Neuroendocrine Tumor
• Stage III Adrenal Cortex Carcinoma
• Stage III Thyroid Gland Medullary Carcinoma
• Stage IIIA Merkel Cell Carcinoma
• Stage IIIB Merkel Cell Carcinoma
• Stage IV Adrenal Cortex Carcinoma
• Stage IV Merkel Cell Carcinoma
• Stage IVA Thyroid Gland Medullary Carcinoma
• Stage IVB Thyroid Gland Medullary Carcinoma
• Stage IVC Thyroid Gland Medullary Carcinoma
• Thymic Carcinoid Tumor
• VIP-Producing Neuroendocrine Tumor
• Well Differentiated Adrenal Cortex Carcinoma
• Zollinger Ellison Syndrome

Interventions

Type	Name	Description
DRUG	Capecitabine	Given PO
DRUG	Temozolomide	Given PI
DRUG	Veliparib	given PO
OTHER	Pharmacological Study	Correlative studies
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2017-12-01
• Primary completion: 2019-02-01
• Completion: 2020-02-01
• First posted: 2016-07-13
• Last updated: 2017-09-28

Regulatory

• FDA-regulated drug study