Status:
COMPLETED
A Study of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced Malignancies
Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00421044
Start Date
May 1 2006
Last Update
January 11 2012
Active Locations (3)
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1
University of California San Diego/Moores Cancer Center
La Jolla, California, United States, 92093-0987
2
Institute for Drug Development Cancer Therapy & Research Center/The University of Texas Health Science Center
San Antonio, Texas, United States, 78229
3
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229