Adult Solid Neoplasm Clinical Trial
Official title:
Phase I Study of ABT-888 in Combination With Gemcitabine in Patients With Advanced Malignancies
This phase I trial is studying the side effects and best dose of giving ABT-888 together with gemcitabine hydrochloride in treating patients with advanced solid tumors. ABT-888 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as 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 ABT-888 together with gemcitabine hydrochloride may kill more tumor cells.
PRIMARY OBJECTIVES:
I. Establish the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLTs) of the
combination of ABT-888 and gemcitabine (gemcitabine hydrochloride) in patients with advanced
solid tumors.
SECONDARY OBJECTIVES:
I. Establish the safety and tolerability of the combination of ABT-888 and gemcitabine in
patients with solid tumors.
II. Determine the effects of ABT-888 and gemcitabine treatment on DNA damage response by
analysis of markers such as Ataxia telangiectasia mutated (ATM) in peripheral blood
mononuclear cells (PBMCs).
III. Determine the pharmacokinetics of ABT-888 and gemcitabine when administered in
combination.
IV. Determine the generation of gemcitabine triphosphate in PBMCs. V. Document any evidence
of antitumor response.
OUTLINE: This is a dose-escalation study.
Patients receive oral ABT-888 twice daily on days 1-14 and gemcitabine hydrochloride IV over
30 minutes on days 1, 8, and 15. Courses repeat every 21* days in the absence of disease
progression or unacceptable toxicity.
After completion of study therapy, patients are followed up for at least 4 weeks.
NOTE: *Patients previously enrolled on a 4-week schedule (ABT-888 twice daily on days 1-21
with gemcitabine IV over 30 minutes once weekly on days 1, 8, and 15, and courses repeating
every 28 days) will continue on the 4-week schedule.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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