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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00420524

Collaborator

(none)

Enrollment

Locations

Arms

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Malignancies Tumors	Drug: Patupilone/EPO906	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A (Normal liver function)	Drug: Patupilone/EPO906
Experimental: Arm B (Mild liver dysfunction)	Drug: Patupilone/EPO906
Experimental: Arm C (Moderate liver dysfunction)	Drug: Patupilone/EPO906

Arm

Intervention/Treatment

Experimental: Arm A (Normal liver function)

Drug: Patupilone/EPO906

Experimental: Arm B (Mild liver dysfunction)

Drug: Patupilone/EPO906

Experimental: Arm C (Moderate liver dysfunction)

Drug: Patupilone/EPO906

Outcome Measures

Primary Outcome Measures

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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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