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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 March 2013 |
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Main ID: |
NCT01267084 |
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Date of registration:
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23/12/2010 |
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Primary sponsor: |
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Public title:
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A Study to Assess the Potential Effects of Ketoconazole on the Pharmacokinetics of Trabectedin in Patients With Advanced Malignancies
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Scientific title:
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An Open-Label, Multicenter Study to Assess the Potential Effects of Ketoconazole on the Pharmacokinetics of Trabectedin in Subjects With Advanced Malignancies |
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Date of first enrolment:
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February 2011 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01267084 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Janssen Research & Development, LLC C. Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen Research & Development, LLC |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neoplasm Metastases
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Intervention(s)
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Drug: Part A
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Drug: Part B, Sequence 1
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Drug: Part B, Sequence 2
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Primary Outcome(s)
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Pharmacokinetics of ketoconazole
[Time Frame: 1 day during Sequence 1 and Sequence 2 after ketoconazole is coadministered with trabectedin]
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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]
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Secondary Outcome(s)
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Evaluation of Survival data
[Time Frame: At a time point to be determined by the sponsor at a later date]
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Findings from clinical laboratory evaluations
[Time Frame: Time from 1st dose of trabectedin up to 30 days after the last dose of trabectedin]
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Findings from physical examinations
[Time Frame: Time from 1st dose of trabectedin up to 30 days after the last dose of trabectedin]
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Findings from vital signs measurements
[Time Frame: Time from 1st dose of trabectedin up to 30 days after the last dose of trabectedin]
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Number of patients with adverse events
[Time Frame: Time from 1st dose of trabectedin up to 30 days after the last dose of trabectedin]
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Secondary ID(s)
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CR017539
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ET7430VC1003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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