A Study to Assess the Potential Effects of Ketoconazole on the Pharmacokinetics of Trabectedin in Patients With Advanced Malignancies
Neoplasm Metastases
About this trial
This is an interventional treatment trial for Neoplasm Metastases focused on measuring Trabectedin (YONDELIS), Ketoconazole, Antineoplastic Agents, Solid tumors, Locally advanced or metastatic disease, Chemotherapy, Pharmacokinetics
Eligibility Criteria
Inclusion Criteria:
- Patients with locally advanced or metastatic disease, any solid tumor except hepatocellular carcinoma (cancer of the liver), who have been relapsed or had progressive disease following standard of care treatment with chemotherapy prior to enrollment, or intolerant to prior standard of care treatment with chemotherapy
Exclusion Criteria:
- Patients with previous exposure to trabectedin
- Patients with cancer that has metastasized (spread) to the central nervous system
- Patients with known liver disease
- Patients who had a myocardial infarct (heart attack) within 6 months before enrollment or who have any other clinically significant or unstable medical condition as assessed by the Investigator
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Part 1
Part 2
Patients will receive trabectedin+ketoconazole followed by trabectedin alone. Each cycle will be will be separated by 21 days. Patients will receive 6 total consecutive doses of ketoconazole. Dexamethasone or equivalent steroid will be administered before trabectedin in each cycle.
Patients will receive 1 of 2 treatment sequences; Sequence 1: trabectedin+ketoconazole followed by trabectedin alone or Sequence 2: trabectedin alone followed by trabectedin+ketoconazole. Each cycle will be separated by 21 days. Patients will receive 15 total consecutive doses of ketoconazole. Dexamethasone or equivalent steroid will be administered before trabectedin in each cycle.