Clinical trial NCT00420524: A Study of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Malignancies
Tumors
Keywords: EPO
Patupilone
Solid Tumors
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To assess the effect of hepatic impairment on the pharmacokinetics of patupilone and its metabolite
timeFrame: After completion of the study (approximately 6 weeks from treatment)
measure: To determine the maximum tolerated dose of patupilone in patients with hepatic impairment
timeFrame: After completion of the study (approximately 6 weeks from treatment)
Secondary outcomes:
measure: To correlate the level of hepatic dysfunction to observed toxicity and pharmacokinetics
timeFrame: After completion of the study (approximately 6 weeks from treatment)
measure: 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
timeFrame: After completion of the study (approximately 6 weeks from treatment)
measure: To evaluate the preliminary anti-tumor activity which will be assessed by radiological scans every 6 weeks
timeFrame: After completion of the study (approximately 6 weeks from treatment)
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego/Moores Cancer Center
state: California
city: Albuquerque
country: United States
facility: Cancer Research and Treatment Center
state: New Mexico
city: San Antonio
country: United States
facility: Institute for Drug Development Cancer Therapy & Research Center/The University of Texas Health Science
state: Texas
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics
state: Texas
Study officials:
affiliation: Novartis Pharmeceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: