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Capecitabine PO BID on days 1-14, temozolomide PO BID on days 10-14 and veliparib PO BID on days 10-14.

Pharmacological Study

Laboratory Biomarker Analysis

Jordan Berlin, M.D.

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.

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

National Cancer Institute (NCI)

Vanderbilt-Ingram Cancer Center

Professor of Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Veliparib, Capecitabine, and Temozolomide in Patients With Advanced, Metastatic, and Recurrent Neuroendocrine Tumor	NCT02831179	Functional Panc... Malignant Somat... Merkel Cell Car... Metastatic Adre... Metastatic Carc... Multiple Endocr... Multiple Endocr... Multiple Endocr... Neuroendocrine ... Non-Functional ... Pancreatic Gluc... Pancreatic Insu... Recurrent Adren... Recurrent Adren... Recurrent Merke... Somatostatin-Pr... Stage III Adren... Stage III Thyro... Stage IIIA Merk... Stage IIIB Merk... Stage IV Adrena... Stage IV Merkel... Stage IVA Thyro... Stage IVB Thyro... Stage IVC Thyro... Thymic Carcinoi... VIP-Producing N... Well Differenti... Zollinger Ellis...	Capecitabine Temozolomide Veliparib Pharmacological... Laboratory Biom...	18 Years -	Vanderbilt-Ingram Cancer Center
Veliparib, Capecitabine, and Temozolomide in Patients With Advanced, Metastatic, and Recurrent Neuroendocrine Tumor	NCT02831179	Functional Panc... Malignant Somat... Merkel Cell Car... Metastatic Adre... Metastatic Carc... Multiple Endocr... Multiple Endocr... Multiple Endocr... Neuroendocrine ... Non-Functional ... Pancreatic Gluc... Pancreatic Insu... Recurrent Adren... Recurrent Adren... Recurrent Merke... Somatostatin-Pr... Stage III Adren... Stage III Thyro... Stage IIIA Merk... Stage IIIB Merk... Stage IV Adrena... Stage IV Merkel... Stage IVA Thyro... Stage IVB Thyro... Stage IVC Thyro... Thymic Carcinoi... VIP-Producing N... Well Differenti... Zollinger Ellis...	Capecitabine Temozolomide Veliparib Pharmacological... Laboratory Biom...	18 Years -	Vanderbilt-Ingram Cancer Center

Spots Global Cancer Trial Database for stage iiia merkel cell carcinoma