A Study of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function

Completed · Phase 1

Conditions studied: Advanced Malignancies, Tumors

In brief

This phase I study will determine the pharmacokinetic profile of patupilone in patients with mild or moderately impaired hepatic function within 2 cycles of treatment. The study population for this trial consists of patients with a documented advanced solid tumor. Patients will be stratified into 3 groups: those with normal liver function, and those with mild or moderate liver dysfunction.

Key facts

Study ID

NCT00420524

Run by

Novartis Pharmaceuticals

People needed

36

Starts

2006-01-01

Last updated by the study team

2020-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• World Health Organization (WHO) Performance Status score of: 0 - you are fully active and more or less as you were before your illness; 1 - you cannot carry out heavy physical work, but can do anything else; or 2 - you are up and about more than half the day, you can look after yourself, but are not well enough to work.
• Life expectancy of 3 months or more
• Patients with measurable or evaluable disease who have histologically documented advanced solid tumor and who have progressed after systemic therapy or for whom standard systemic therapy does not exist

You may not qualify if…

• Severe and/or uncontrolled medical disease
• Known diagnosis of human immunodeficiency virus (HIV) infection
• Presence of any other active or suspected acute or chronic uncontrolled infection
• Severe cardiac insufficiency, with uncontrolled and/or unstable cardiac or coronary artery disease
• History of another malignancy within 5 years prior to study entry, except for curatively treated non-melanotic skin cancer or cervical cancer in situ
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• University of California San Diego/Moores Cancer Center — La Jolla, California, United States
• Cancer Research and Treatment Center — Albuquerque, New Mexico, United States
• Institute for Drug Development Cancer Therapy & Research Center/The University of Texas Health Science — San Antonio, Texas, United States
• South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.