A Pharmacokinetic Study of Trabectedin in Patients With Advanced Malignancies and Hepatic Dysfunction
An Open-Label, Multicenter, Pharmacokinetic Study of Trabectedin in Subjects With Advanced Malignancies and Hepatic Dysfunction
2 other identifiers
interventional
15
4 countries
11
Brief Summary
The purpose of this study is to characterize the pharmacokinetics (blood levels) of trabectedin after administration to patients with advanced malignancies and hepatic (liver) dysfunction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2010
Typical duration for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 23, 2010
CompletedFirst Posted
Study publicly available on registry
January 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedFebruary 15, 2016
February 1, 2016
3.3 years
December 23, 2010
February 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics of trabectedin
At protocol-specified time points for up to 8 days
Secondary Outcomes (5)
Number of patients with adverse events
Up to 30 days after the administration of trabectedin
Findings from clinical laboratory evaluations
Up to 30 days after the administration of trabectedin
Findings from vital signs measurements
Up to 30 days after the administration of trabectedin
Findings from physical examinations
Up to 30 days after the administration of trabectedin
Evaluate survival data
at a time point to be determined by the sponsor at a later date.
Study Arms (2)
Trabectedin 1.3 mg/m^2 plus Dexamethasone
EXPERIMENTALControl group Trabectedin 1.3 mg/m\^2 i.v.will be administered on Day 1. Dexamethasone will be administered 30 minutes prior to trabectedin.
Trabectedin 0.58 mg/m^2 plus Dexamethasone
EXPERIMENTALHepatic dysfunction group Trabectedin 0.58 mg/m\^2 (or adjusted dose) i.v. will be administered on Day 1. Dexamethasone will be administered 30 minutes prior to trabectedin.
Interventions
Trabectedin 0.58 or 1.3 mg/m\^2 (or adjusted dose) i.v. will be administered on Day 1.
Dexamethasone will be administered as 20 mg/m\^2, 30 minutes prior to trabectedin.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Research & Development, LLClead
- PharmaMarcollaborator
Study Sites (11)
Unknown Facility
Scottsdale, Arizona, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Tacoma, Washington, United States
Unknown Facility
Edegem, Belgium
Unknown Facility
Wilrijk, Belgium
Unknown Facility
Edmonton, Alberta, Canada
Unknown Facility
Barcelona, Spain
Unknown Facility
Madrid, Spain
Related Publications (1)
Calvo E, Azaro A, Rodon J, Dirix L, Huizing M, Senecal FM, LoRusso P, Yee L, Poggesi I, de Jong J, Triantos S, Park YC, Knoblauch RE, Parekh TV, Demetri GD, von Mehren M. Hepatic safety analysis of trabectedin: results of a pharmacokinetic study with trabectedin in patients with hepatic impairment and experience from a phase 3 clinical trial. Invest New Drugs. 2018 Jun;36(3):476-486. doi: 10.1007/s10637-017-0546-9. Epub 2017 Nov 27.
PMID: 29177975DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC C. Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2010
First Posted
January 10, 2011
Study Start
December 1, 2010
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
February 15, 2016
Record last verified: 2016-02