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
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 tr...
Eligibility Criteria
Inclusion
- 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 :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00420524
Start Date
January 1 2006
Last Update
December 9 2020
Active Locations (4)
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1
University of California San Diego/Moores Cancer Center
La Jolla, California, United States, 92093-0987
2
Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131-5636
3
Institute for Drug Development Cancer Therapy & Research Center/The University of Texas Health Science
San Antonio, Texas, United States, 78229
4
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229