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
  Purpose

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.


Condition Intervention Phase
Neoplasm Metastases
Hepatic Insufficiency
Drug: Hepatic dysfunction group
Drug: Control group
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Pharmacokinetic Study of Trabectedin in Subjects With Advanced Malignancies and Hepatic Dysfunction

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Pharmacokinetics of trabectedin [ Time Frame: At protocol-specified time points for up to 8 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 22
Study Start Date: December 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: 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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273493

Contacts
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

Locations
United States, Arizona
Completed
Scottsdale, Arizona, United States
United States, Michigan
Completed
Detroit, Michigan, United States
United States, New York
Completed
New York, New York, United States
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States
United States, Utah
Recruiting
Salt Lake City, Utah, United States
United States, Washington
Active, not recruiting
Tacoma, Washington, United States
Belgium
Recruiting
Edegem, Belgium
Recruiting
Wilrijk, Belgium
Canada, Alberta
Recruiting
Edmonton, Alberta, Canada
Spain
Recruiting
Barcelona, Spain
Recruiting
Sanchinarro, Spain
Sponsors and Collaborators
Janssen Research & Development, LLC
PharmaMar
Investigators
Study Director: Janssen Research & Development, LLC C. Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01273493     History of Changes
Other Study ID Numbers: CR017542, ET7430OVC1004
Study First Received: December 23, 2010
Last Updated: September 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Trabectedin, YONDELIS
Antineoplastic Agents
Solid tumors
Locally advanced or metastatic disease
Chemotherapy
Pharmacokinetics
Hepatic Dysfunction

Additional relevant MeSH terms:
Neoplasm Metastasis
Hepatic Insufficiency
Liver Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Diseases
Dexamethasone
Trabectedin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014