Status:
COMPLETED
ABT-888 and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Solid Neoplasm
BRCA1 Mutation Carrier
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
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 advanc...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed solid tumors meeting 1 of the following criteria:
- Progressive disease following standard therapy
- Disease for which acceptable standard treatment options do not exist
- May have received 0-2 prior chemotherapeutic regimens (single-agent or combination chemotherapies)
- Willing to undergo BRCA mutation analysis
- Known BRCA mutations allowed
- All patients, at any dose level, without a known BRCA mutation undergo screening with the BRCAPRO program to assess the likelihood of having a BRCA mutation
- Patients with a BRCAPRO likelihood of gene mutation of ≥ 20% must undergo BRCA gene testing by the Myriad Genetic Laboratories in order to participate in the study
- Patients are eligible whether they have a known deleterious BRCA 1 or 2 mutation or a mutation of uncertain significance
- No CNS disease (e.g., brain metastases or glioma)
- No active seizure or history of seizure disorder
- ECOG performance status 0-2 (Karnofsky 60-100%)
- Life expectancy \> 3 months
- ANC ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Bilirubin \< 2.0 mg/dL
- AST and ALT \< 3 times upper limit of normal
- Creatinine normal OR creatinine clearance \> 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to swallow pills
- HIV-positive patients allowed provided that CD4 counts are \< 500 and not on protease inhibitors
- No uncontrolled diarrhea
- No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situations that would limit compliance with study requirements
- No other concurrent anticancer therapies or agents
- More than 4 weeks since prior major surgery, radiotherapy, or chemotherapy (6 weeks for mitomycin C or nitrosoureas) and recovered
- Prior gemcitabine hydrochloride or PARP inhibition therapy, including ABT-888, allowed
- No prior combination of gemcitabine hydrochloride and any PARP inhibitor
- Concurrent bisphosphonate IV allowed provided treatment was initiated before study therapy (for patients with bone metastases or hypercalcemia)
- Patients with prostate cancer must continue luteinizing-hormone releasing-hormone agonist therapy and discontinue antiandrogens (≥ 6 weeks since bicalutamide and ≥ 4 weeks since flutamide)
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01154426
Start Date
May 1 2010
End Date
October 1 2013
Last Update
July 2 2015
Active Locations (4)
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1
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
2
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
3
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
4
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232