Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Liver Failure

Hepatic Insufficiency

Neoplastic Processes

Liver Diseases

Gastrointestinal Diseases

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Dexamethasone acetate

Trabectedin

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antineoplastic Agents, Alkylating

Alkylating Agents

Control group Trabectedin 1.3 mg/m\^2 i.v.will be administered on Day 1. Dexamethasone will be administered 30 minutes prior to trabectedin.

Hepatic 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.

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.

Janssen Research & Development, LLC C. Clinical Trial

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 dysfunction (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.

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

PharmaMar

Janssen Research & Development, LLC

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Renal Insufficiency

Rubitecan

Topoisomerase I Inhibitors

Enzyme Inhibitors

Cancer patients with liver or renal dysfunction will be treated with rubitecan capsules to define the maximum tolerated dose and the dose-limiting toxicity in this patient population, and to perform pharmacokinetic studies of rubitecan in this patient population.

Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction

Phase I Study of Rubitecan (RFS 2000) in the Treatment of Cancer Patients With Organ Dysfunction

Astex Pharmaceuticals, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Pharmacokinetic Study of Trabectedin in Patients With Advanced Malignancies and Hepatic Dysfunction	NCT01273493	Neoplasm Metast... Hepatic Insuffi...	Trabectedin Dexamethasone	18 Years - 70 Years	Janssen Research & Development, LLC
Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction	NCT00113113	Tumors	Rubitecan	18 Years -	Astex Pharmaceuticals, Inc.
Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction	NCT00113113	Tumors	Rubitecan	18 Years -	Astex Pharmaceuticals, Inc.

Spots Global Cancer Trial Database for hepatic dysfunction