A Pharmacokinetic Study of Trabectedin in Patients With Advanced Malignancies and Hepatic Dysfunction

• Register: ClinicalTrials.gov
• Last refreshed on: 23 February 2016
• Main ID: NCT01273493
• Date of registration: 23/12/2010
• Prospective Registration: No
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Pharmacokinetic Study of Trabectedin in Patients With Advanced Malignancies and Hepatic Dysfunction
• Scientific title: An Open-Label, Multicenter, Pharmacokinetic Study of Trabectedin in Subjects With Advanced Malignancies and Hepatic Dysfunction
• Date of first enrolment: December 2010
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01273493
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Belgium, Canada, Spain, United States

Contacts

• Name: Janssen Research & Development, LLC C. Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with locally advanced or metastatic disease, any solid tumor except
hepatocellular carcinoma, who have been previously treated with systemic chemotherapy
(chemotherapy administered through the blood) and who have had 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

- Patients with Eastern Cooperative Oncology Group (ECOG) score of <=2 at the time of
screening

- Patients enrolled with hepatic dysfunction must have laboratory test results for
total bilirubin of >1.5x to <=3x the upper limit of normal (ULN) and liver function
tests (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) of <8x
the ULN

- Patients enrolled without hepatic dysfunction must have laboratory test results for
total bilirubin of less than the ULN, alkaline phosphatase (ALP) <=1.5x the ULN, and
AST and ALT of <=the ULN.

Exclusion Criteria:

- Patients with previous exposure to trabectedin

- Patients with known liver disease

- Patients diagnosed with hepatocellular carcinoma, or who have a history of biliary
sepsis within the past 2 years

- Patients unwilling to have a central catheter

- In hepatic dysfunction group, patients with hepatic dysfunction who have Gilbert's
syndrome. Patients signs of encephalopathy (altered brain function).



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Neoplasm Metastases

Hepatic Insufficiency

Intervention(s)

Drug: Dexamethasone

Drug: Trabectedin

Primary Outcome(s)

Pharmacokinetics of trabectedin [Time Frame: At protocol-specified time points for up to 8 days]

Secondary Outcome(s)

Findings from clinical laboratory evaluations [Time Frame: Up to 30 days after the administration of trabectedin]

Findings from physical examinations [Time Frame: Up to 30 days after the administration of trabectedin]

Number of patients with adverse events [Time Frame: Up to 30 days after the administration of trabectedin]

Findings from vital signs measurements [Time Frame: Up to 30 days after the administration of trabectedin]

Evaluate survival data [Time Frame: at a time point to be determined by the sponsor at a later date.]

Secondary ID(s)

ET7430OVC1004

CR017542

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PharmaMar