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

Patients who participated in the core EPO2121 study and did not clinically progress may participate in this extension protocol to further evaluate the safety, tolerability, and efficacy of patupilone.

Key facts

Study ID

NCT00421044

Run by

Novartis Pharmaceuticals

People needed

14

Starts

2006-05-01

Last updated by the study team

2012-01-11

Who can join

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

You may qualify if…

• Completion of the core study is required for participation in the extension.
• 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
• Institute for Drug Development Cancer Therapy & Research Center/The University of Texas Health Science Center — San Antonio, Texas, United States
• South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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