Hepatic Insufficiency Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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). |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen Research & Development, LLC | PharmaMar |
United States, Belgium, Canada, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetics of trabectedin | At protocol-specified time points for up to 8 days | No | |
Secondary | Number of patients with adverse events | Up to 30 days after the administration of trabectedin | No | |
Secondary | Findings from clinical laboratory evaluations | Up to 30 days after the administration of trabectedin | No | |
Secondary | Findings from vital signs measurements | Up to 30 days after the administration of trabectedin | No | |
Secondary | Findings from physical examinations | Up to 30 days after the administration of trabectedin | No | |
Secondary | Evaluate survival data | at a time point to be determined by the sponsor at a later date. | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04097704 -
Pharmacogenetics Sampling of the CC-90007-CP-003 Study Cohort
|
||
Completed |
NCT02161224 -
A Study to Investigate the Exposure and Safety and Tolerability of a Single Dose of FG-4592 in Subjects With Moderately Diminished Liver Function Compared to Those With Normal Liver Function
|
Phase 1 | |
Completed |
NCT00929032 -
Liver Transplantation and Reticuloendothelial Clearance Capacity
|
N/A | |
Completed |
NCT00509210 -
Study of Telaprevir in Subjects With Hepatic Impairment
|
Phase 1 | |
Completed |
NCT02894385 -
Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201)
|
Phase 1 | |
Completed |
NCT03306667 -
Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)
|
Phase 1 | |
Completed |
NCT04867941 -
A Study to Evaluate the Effect of Hepatic Insufficiency on the Pharmacokinetics (PK) of ACP-196
|
Phase 1 | |
Terminated |
NCT02457702 -
Mitochondrial Function in Patients With Severe Liver Disease
|
N/A | |
Completed |
NCT02090621 -
Extracorporeal Photopheresis After Liver Transplant
|
Phase 2 | |
Completed |
NCT02249442 -
Study to Determine the Pharmacokinetics on TPV/r in Subjects With Mild and Moderate Hepatic Insufficiency
|
Phase 1 | |
Completed |
NCT03341884 -
A Study of Ipatasertib in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Participants
|
Phase 1 | |
Completed |
NCT01475136 -
A Study of LY2140023 in Hepatically-Impaired Participants
|
Phase 1 | |
Completed |
NCT00968591 -
Pharmacokinetics of Everolimus in Subjects With Hepatic Insufficiency
|
Phase 1 | |
Completed |
NCT00969813 -
A Safety and Tolerability Study of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function
|
Phase 1 | |
Completed |
NCT00931060 -
Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects
|
N/A | |
Completed |
NCT00416702 -
Safety and Pharmacokinetics of Indacaterol in Healthy Subjects and Those With Impaired Liver Function
|
Phase 1 | |
Completed |
NCT03968848 -
Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite
|
Phase 1 | |
Completed |
NCT00692341 -
Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics
|
Phase 1 | |
Completed |
NCT00314054 -
Study Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy Adults
|
Phase 1 | |
Completed |
NCT05731895 -
A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Liver Problems
|
Phase 1 |