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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Adrenocortical Carcinoma
  • Carcinoid Tumor
  • Carcinoma
  • Carcinoma, Merkel Cell
  • Carcinoma, Neuroendocrine
  • Endocrine Gland Neoplasms
  • Functional Pancreatic Neuroendocrine Tumor
  • Gastrinoma
  • Glucagonoma
  • Insulinoma
  • Malignant Somatostatinoma
  • Merkel Cell Carcinoma
  • Metastatic Adrenal Gland Pheochromocytoma
  • Metastatic Carcinoid Tumor
  • Multiple Endocrine Neoplasia
  • Multiple Endocrine Neoplasia Type 1
  • Multiple Endocrine Neoplasia Type 2A
  • Multiple Endocrine Neoplasia Type 2B
  • Neoplasms
  • Neuroendocrine Neoplasm
  • Neuroendocrine Tumors
  • Non-Functional Pancreatic Neuroendocrine Tumor
  • Pancreatic Glucagonoma
  • Pancreatic Insulinoma
  • Pancreatic Neoplasms
  • Pheochromocytoma
  • Recurrent Adrenal Cortex Carcinoma
  • Recurrent Adrenal Gland Pheochromocytoma
  • Recurrent Merkel Cell Carcinoma
  • Somatostatin-Producing Neuroendocrine Tumor
  • Somatostatinoma
  • 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
  • Thyroid Diseases
  • Thyroid Neoplasms
  • VIP-Producing Neuroendocrine Tumor
  • Vipoma
  • Well Differentiated Adrenal Cortex Carcinoma
  • Zollinger Ellison Syndrome
  • Zollinger-Ellison Syndrome

NCT number NCT02831179
Study type Interventional
Source Vanderbilt-Ingram Cancer Center
Contact
Status Withdrawn
Phase Phase 1
Start date December 2017
Completion date February 2020

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