Trial record 1 of 1 for:    NCT01273493
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A Pharmacokinetic Study of Trabectedin in Patients With Advanced Malignancies and Hepatic Dysfunction

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Janssen Research & Development, LLC
Sponsor:
Collaborator:
PharmaMar
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01273493
First received: December 23, 2010
Last updated: September 5, 2014
Last verified: September 2014

December 23, 2010
September 5, 2014
December 2010
March 2015   (final data collection date for primary outcome measure)
Pharmacokinetics of trabectedin [ Time Frame: At protocol-specified time points for up to 8 days ] [ Designated as safety issue: No ]
Pharmacokinetics of trabectedin [ Time Frame: At protocol-specified time points for 8 days during one 21-day treatment cycle ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01273493 on ClinicalTrials.gov Archive Site
  • Number of patients with adverse events [ Time Frame: Up to 30 days after the administration of trabectedin ] [ Designated as safety issue: No ]
  • Findings from clinical laboratory evaluations [ Time Frame: Up to 30 days after the administration of trabectedin ] [ Designated as safety issue: No ]
  • Findings from vital signs measurements [ Time Frame: Up to 30 days after the administration of trabectedin ] [ Designated as safety issue: No ]
  • Findings from physical examinations [ Time Frame: Up to 30 days after the administration of trabectedin ] [ Designated as safety issue: No ]
  • Evaluate survival data [ Time Frame: at a time point to be determined by the sponsor at a later date. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

This is an open-label (patients will know the names of study drugs they receive), single-dose, study that will examine the pharmacokinetics (blood levels) and assess survival and safety of trabectedin in patients with advanced malignancies who either have hepatic (liver) dysfunction or do not have hepatic dsyfunction (patients enrolled without hepatic dysfunction will be referred to as the control group). Trabectedin is a drug being developed to treat patients with cancer that will be administered intravenously (i.v.) through a catheter (tube) into a central vein. In addition, dexamethasone, 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. Patients who complete the treatment phase of the study 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. A single dose of trabectedin (1.3 mg/m2 in patients in the control group and 0.58 mg/m2 in patients with hepatic dysfunction) will be administered by i.v.infusion over a 3-hour period. The dose of trabectedin may be adjusted if necessary for patients with hepatic dysfunction subsequently enrolled in the study. All patients will be administered dexamethasone 20 mg i.v. (or equivalent) approximately 30 minutes before the administration of trabectedin.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Neoplasm Metastases
  • Hepatic Insufficiency
  • Drug: Hepatic dysfunction group
    Trabectedin 0.58 mg/m2 (or adjusted dose) i.v. will be administered on Day 1. Dexamethasone will be administered 30 minutes prior to trabectedin.
  • Drug: Control group
    Trabectedin 1.3 mg/m2 i.v.will be administered on Day 1. Dexamethasone will be administered 30 minutes prior to trabectedin.
  • Experimental: 001
    Control group Trabectedin 1.3 mg/m2 i.v.will be administered on Day 1. Dexamethasone will be administered 30 minutes prior to trabectedin.
    Intervention: Drug: Control group
  • Experimental: 002
    Hepatic dysfunction group Trabectedin 0.58 mg/m2 (or adjusted dose) i.v. will be administered on Day 1. Dexamethasone will be administered 30 minutes prior to trabectedin.
    Intervention: Drug: Hepatic dysfunction group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
22
March 2015
March 2015   (final data collection date for primary outcome measure)

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).
Both
18 Years to 70 Years
No
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com
United States,   Belgium,   Canada,   Spain
 
NCT01273493
CR017542, ET7430OVC1004
Yes
Janssen Research & Development, LLC
Janssen Research & Development, LLC
PharmaMar
Study Director: Janssen Research & Development, LLC C. Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP