Veliparib, Capecitabine, and Temozolomide in Patients With Advanced, Metastatic, and Recurrent Neuroendocrine Tumor
|ClinicalTrials.gov Identifier: NCT02831179|
Recruitment Status : Withdrawn (Loss of funding support)
First Posted : July 13, 2016
Last Update Posted : September 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Capecitabine Drug: Temozolomide Drug: Veliparib Other: Pharmacological Study Other: Laboratory Biomarker Analysis||Phase 1|
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Veliparib (ABT-888) in Combination With Capecitabine and Temozolomide in Advanced Well-Differentiated Neuroendocrine Tumors|
|Estimated Study Start Date :||December 2017|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2020|
Experimental: Treatment (capecitabine, temozolomide, veliparib)
Capecitabine PO BID on days 1-14, temozolomide PO BID on days 10-14 and veliparib PO BID on days 10-14.
Other: Pharmacological Study
Other: Laboratory Biomarker Analysis
- Maximum tolerated dose determined by dose limiting toxicities defined as any toxicity in the first course evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 28 days ]
- Response rate measured as complete response, partial response or stable disease according to RECIST 1.1 criteria [ Time Frame: 56 days (2 courses) ]
- Response duration [ Time Frame: Up to 4 weeks ]
- Progression Free Survival [ Time Frame: From start of treatment to time of progression or death, assessed up to 4 weeks ]
- Overall Survival [ Time Frame: Up to 4 weeks ]
- Poly-adenosine diphosphate (ADP)-ribosylated (PAR) level [ Time Frame: Baseline to day 15 of course 1 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831179
|Principal Investigator:||Jordan Berlin, M.D.||Vanderbilt-Ingram Cancer Center|