NCT Number: NCT00421044
A Study of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
University of California San Diego/Moores Cancer Center, La Jolla, California, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
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
Time frame: at completion of the study
-
To evaluate the preliminary anti-tumor activity which will be assessed by radiological scans every 6 weeks
Time frame: at completion of the study
Sponsors and collaborators
Lead sponsor
Novartis Pharmaceuticals
Industry
Registry information
Official study title
An Open-label, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function
Important dates
- Study start
- 2006
- Primary completion
- 2008
- First posted
- Jan 11, 2007
- Registry last updated
- Jan 11, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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