A Study of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function

Tumors Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420524
• Other study ID #: CEPO906A2121
• Status: Completed
• Phase: Phase 1
• Start date: January 2006

Study information

• Verified date: December 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 trial consists of patients with a documented advanced solid tumor. Patients will be stratified into 3 groups: those with normal liver function, and those with mild or moderate liver dysfunction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Advanced Malignancies
• Neoplasms
• Tumors

Intervention

Drug:
• Patupilone/EPO906

Locations

Country	Name	City	State
United States	Cancer Research and Treatment Center	Albuquerque	New Mexico
United States	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	San Antonio	Texas
United States	South Texas Accelerated Research Therapeutics	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effect of hepatic impairment on the pharmacokinetics of patupilone and its metabolite		After completion of the study (approximately 6 weeks from treatment)
Primary	To determine the maximum tolerated dose of patupilone in patients with hepatic impairment		After completion of the study (approximately 6 weeks from treatment)
Secondary	To correlate the level of hepatic dysfunction to observed toxicity and pharmacokinetics		After completion of the study (approximately 6 weeks from treatment)
Secondary	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		After completion of the study (approximately 6 weeks from treatment)
Secondary	To evaluate the preliminary anti-tumor activity which will be assessed by radiological scans every 6 weeks		After completion of the study (approximately 6 weeks from treatment)

External Links

•   Results can be found for CEPO906A2121 on the Novartis Clinical Trials Results Website