A Phase 1/2 interventional study of Trabectedin and Ketoconazole in Neoplasm Metastases, sponsored by Janssen Research & Development, LLC. Completed at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-14.
Sponsored by Janssen Research & Development, LLC · Phase 1/2, Interventional, and Treatment
The purpose of this study is to evaluate the potential effects of ketoconazole on blood levels of trabectedin after administration to patients with advanced malignancies.
This is an open-label study (patients will know the names of the study drugs they receive), randomized (patients will be assigned 1 of 2 treatment sequences by chance) that is designed to examine the pharmacokinetics (blood levels) of trabectedin when coadministered with ketoconazole in patients with advanced malignancies. Study drugs include trabectedin and ketoconazole. Trabectedin is a drug being developed to treat patients with cancer that will be administered intravenously (IV) through a catheter (tube) into a central vein over a period of 3 hours once every 21 days with and without ketoconazole. Ketoconazole is an antifungal agent taken as tablets orally (by mouth), that may interfere with the metabolism of trabectedin. In addition, dexamethasone or equivalent steroid, a drug used to prevent nausea and vomiting in chemotherapy patients that may have protective effects on the liver, will be administered to patients before the administration of trabectedin in each treatment cycle. This study will consist of 2 parts, Part A and B. In Part A, trabectedin+ketoconazole followed by trabectedin alone will be administered with ketoconazole to 4 patients to evaluate safety. If the safety and PK data collected in Part A is deemed acceptable, enrollment in Part B of the study will begin and patients will receive 1 of 2 treatment sequences of trabectedin and ketoconazole. Patients in Part A and Part B who complete the treatment phase of the study or who are discontinued due to ketoconazole toxicity, and who in the opinion of the investigator would derive an overall clinical benefit from further treatment with trabectedin will have the opportunity to continue treatment with trabectedin in the optional extension phase. The dose and schedule of trabectedin may be modified by the treating physician in the optional extension phase to be more appropriate for the type of malignancy being treated. Patients will receive 20 mg of IV dexamethasone or equivalent steroid prior to trabectedin administration in all cycles. Part A consists of ketoconazole 200mg 2x daily+trabectedin 0.2mg/m2 i.v. followed 21 days later by trabectedin 1.3mg/m2 i.v. Part B consists of Sequence 1 (ketoconazole 200mg 2x daily+trabectedin 0.2mg/m2 i.v.followed 21 days later by trabectedin 1.3mg/m2 i.v.) and Sequence 2 (trabectedin 1.3mg/m2 i.v followed 21 days later by ketoconazole 200mg 2x daily+trabectedin 0.2mg/m2 i.v). Dexamethasone 20mg i.v. or equivalent, will be given 30 minutes before trabectedin in each cycle.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 884 are open to participants now.
This study's enrollment of 12 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
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Exclusion Criteria:
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.
Drug: Trabectedin · Drug: Ketoconazole · Drug: Dexamethasone or equivalent steroid
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.
Drug: Trabectedin · Drug: Ketoconazole · Drug: Dexamethasone or equivalent steroid
Patients will receive trabectedin 1.3 mg/m2 when given alone and 0.2mg/m2 when given with ketoconazole, intravenously (into a vein) for 3-hour.
Patients will receive ketoconazole 1 X 200 mg tablet, two times a day, orally (by mouth)
Patients will receive dexamethasone 20 mg or equivalent steroid intravenously, 30 minutes before trabectedin in each cycle.
Pharmacokinetics of trabectedin
Time frame: At protocol-specified time points for up to 8 days during each 21-day cycle in Sequence 1 and Sequence 2
Pharmacokinetics of ketoconazole
This will be measured when ketoconazole will be administered.
Time frame: 1 day during Sequence 1 or Sequence 2 after ketoconazole is coadministered with trabectedin
Number of patients with adverse events
Time frame: Time from 1st dose of trabectedin up to 30 days after the last dose of trabectedin
Findings from clinical laboratory evaluations
Time frame: Time from 1st dose of trabectedin up to 30 days after the last dose of trabectedin
Findings from vital signs measurements
Time frame: Time from 1st dose of trabectedin up to 30 days after the last dose of trabectedin
Findings from physical examinations
Time frame: Time from 1st dose of trabectedin up to 30 days after the last dose of trabectedin
Evaluation of Survival data
Time frame: At a time point to be determined by the sponsor at a later date
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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