Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
Phase I Study of Veliparib (ABT-888) in Combination With Cisplatin Plus Gemcitabine in Advanced Biliary, Pancreatic, Urothelial, and Non-small Cell Lung Cancer
This phase I clinical trial is studying the side effects and best dose of veliparib and gemcitabine hydrochloride when given with cisplatin in treating patients with advanced biliary, pancreatic, urothelial, or non-small cell lung cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Veliparib may help cisplatin and gemcitabine hydrochloride work better by making tumor cells more sensitive to the drugs.
PRIMARY OBJECTIVES:
I. Determine the maximum-tolerated dose of veliparib (ABT-888) (days 1-12 of a 21-day
schedule) in combination with cisplatin (day 3) and gemcitabine (days 3, 10) in patients
with advanced, previously untreated carcinoma of the bile ducts, gallbladder or pancreas,
non-small cell lung cancer, or transitional cell carcinoma of the bladder/urothelial tract.
SECONDARY OBJECTIVES:
I. Describe the dose-limiting toxicity (DLT) and other toxicities associated with veliparib
in combination with cisplatin plus gemcitabine as assessed by CTCAE v4.0.
II. Determine the recommended phase 2 dose of veliparib (ABT-888) (RP2D) in combination with
cisplatin plus gemcitabine.
III. Document anti-tumor activity of veliparib (ABT-888), cisplatin, and gemcitabine as
assessed by RECIST 1.1.
IV. Determine the plasma pharmacokinetics of veliparib (ABT-888), cisplatin, and
gemcitabine.
V. Determine the abundance of gemcitabine triphosphate in PBMCs following gemcitabine
administration.
VI. Measure the abundance of DNA-platinum adducts in tumor tissue following cisplatin
administration.
VII. Measure PARP enzymatic activity in PBMC and tumor tissue following study treatment.
VIII. Perform an exploratory correlation between abundance of BRCA and other proteins
assessed by tumor immunohistochemistry and clinical response.
OUTLINE: This is a multicenter, dose-escalation study of veliparib and gemcitabine
hydrochloride. Patients are stratified according to presence of suspected or known BRCA
mutations (no vs yes).
Patients receive veliparib orally every 12 hours on days 1-12, gemcitabine hydrochloride IV
over 30 minutes on days 3 and 10, and cisplatin IV over 60-120 minutes on day 3. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients with suspected or known germline BRCA mutations may continue to receive
single-agent veliparib continuously in the absence of disease progression or unacceptable
toxicity. Patients may undergo blood, tumor tissue, and hair follicle sample collection
periodically for pharmacokinetic and correlative studies.
After completion of study treatment, patients are followed up for 4 weeks.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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