An Early Phase 1 Study of ABT-888 in Combination with Carboplatin and Paclitaxel in Patients with Hepatic or Renal Dysfunction and Solid Tumors
Johns Hopkins Kimmel Cancer Center in Baltimore
To help us best learn how to use new drugs that may be effective treatments for cancer in patients with varying degrees of renal or hepatic dysfunction. Find the highest tolerable dose of ABT888 in combination with Carboplatin and paclitaxel; provide dosing recommendations; test the safety of treating subjects with advanced solid malignancies in patients with varying degrees of renal or hepatic dysfunction; determine the dose limiting toxicity. Study how the combination of ABT888 and Carboplatin and paclitaxel is absorbed and handled by the body.
Age 18+ with confirmed malignancy that is metastatic, and for which no standard chemo or surgical treatment is available who also have some degree of liver or kidney dysfunction (but cannot have both). Good performance status, adequate blood counts. Prior chemotherapy and radiation greater than 4 weeks ago. Stable brain lesion(s) allowed if stable for greater than 4weeks. No HIV-positive patients on combination antiretroviral therapy, pregnant women or patients with other illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Patients who have received and progressed on ABT888, carboplatin and or paclitaxel are excluded as well.
ABT-888 will be administered orally without regards to meals. A single dose of 80 mg of ABT-888 will be given on D-5 or D -6, depending on group assignment. Thereafter, ABT-888 will be given twice a day for the first 7 days in treatment cycles 1 and beyond. Missed doses should not be made up. Carboplatin and paclitaxel will be given intravenously on day 3 with doses dependent on degree or kidney or liver dysfunction. Treatment cycles for all groups will be repeated every 3 weeks. In the absence of treatment delays due to side effects, treatment may continue for up to 6 cycles or until disease progression, unacceptable toxicity, patient withdraws or judgment of the investigator is that patient would not tolerate further trial therapy.
06/27/2016 05:03 AM