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

Phase 1

Completed

• Conditions: Advanced Malignancies; Tumors
• Interventions: Drug: Patupilone/EPO906

• Registration Number: NCT00420524
• Lead Sponsor: Novartis Pharmaceuticals

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-01-09
• Study First Submitted QC: 2007-01-10
• Study First Posted: 2007-01-11
• Primary Completion: 2010-07
• Status Verified: 2011-12
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B (Mild liver dysfunction)	Patupilone/EPO906	-
Arm C (Moderate liver dysfunction)	Patupilone/EPO906	-
Arm A (Normal liver function)	Patupilone/EPO906	-

Primary Outcome Measures

Name	Time	Method
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)
To determine the maximum tolerated dose of patupilone in patients with hepatic impairment	After completion of the study (approximately 6 weeks from treatment)

Secondary Outcome Measures

Name	Time	Method
To correlate the level of hepatic dysfunction to observed toxicity and pharmacokinetics	After completion of the study (approximately 6 weeks from treatment)
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)
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)

Trial Locations

Locations (4)

Cancer Research and Treatment Center; 🇺🇸 Albuquerque, New Mexico, United States

Institute for Drug Development Cancer Therapy & Research Center/The University of Texas Health Science; 🇺🇸 San Antonio, Texas, United States

University of California San Diego/Moores Cancer Center; 🇺🇸 La Jolla, California, United States

South Texas Accelerated Research Therapeutics; 🇺🇸 San Antonio, Texas, United States