Protocol
09-154
Full Title
A Phase I Study of ABT-888 in Combination with Carboplatin and Gemcitabine in Subjects with Advanced Solid Tumors
Purpose
The purpose of this study is to evaluate the safety and effectiveness of various doses of an investigational drug called ABT-888 when given with carboplatin and gemcitabine in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, especially those experiencing their first recurrence.
ABT-888 kills cancer cells by blocking a protein called PARP, thereby preventing the repair of DNA or genetic damage in cancer cells and possibly making them more susceptible to anticancer drugs. It can also work well in cancer cells that do not have functional BRCA, a protein which helps to fix DNA damage. About 10 percent of ovarian cancer patients have an inherited defect in BRCA.
Carboplatin and gemcitabine are used routinely to treat these cancers. ABT-888 may make the carboplatin/gemcitabine treatment work more effectively.
Investigator
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer that has recurred for the first time and is either BRCA-deficient or sensitive to platinum-containing drugs.
- At least 4 weeks must have passed since completion of prior therapy and entry into the study (6 months since platinum-containing therapy).
- Patients must not be confined to a bed or chair for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Katherine M. Bell-McGuinn at 646-888-4221.
Disease(s)
Ovarian Cancer
Locations
ClinicalTrials.gov
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