A Study of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function
Phase 1
Completed
- Conditions
- Advanced MalignanciesTumors
- Interventions
- Drug: Patupilone/EPO906
- Registration Number
- NCT00421044
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A (Normal liver function) Patupilone/EPO906 - Arm B (Mild liver dysfunction) Patupilone/EPO906 - Arm C (Moderate liver dysfunction) Patupilone/EPO906 -
- Primary Outcome Measures
Name Time Method Safety and tolerability in patients with hepatic impairment will be assessed by adverse events (AEs), serious adverse events (SAEs) and out of range lab values at completion of the study To evaluate the preliminary anti-tumor activity which will be assessed by radiological scans every 6 weeks at completion of the study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
University of California San Diego/Moores Cancer Center
🇺🇸La Jolla, California, United States
South Texas Accelerated Research Therapeutics
🇺🇸San Antonio, Texas, United States
Institute for Drug Development Cancer Therapy & Research Center/The University of Texas Health Science Center
🇺🇸San Antonio, Texas, United States