A Study of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function
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
1 other identifier
interventional
36
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 9, 2007
CompletedFirst Posted
Study publicly available on registry
January 11, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedDecember 9, 2020
December 1, 2011
4.5 years
January 9, 2007
December 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
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)
Study Arms (3)
Arm A (Normal liver function)
EXPERIMENTALArm B (Mild liver dysfunction)
EXPERIMENTALArm C (Moderate liver dysfunction)
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of California San Diego/Moores Cancer Center
La Jolla, California, 92093-0987, United States
Cancer Research and Treatment Center
Albuquerque, New Mexico, 87131-5636, United States
Institute for Drug Development Cancer Therapy & Research Center/The University of Texas Health Science
San Antonio, Texas, 78229, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229, United States
Related Links
MeSH Terms
Conditions
Interventions
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmeceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2007
First Posted
January 11, 2007
Study Start
January 1, 2006
Primary Completion
July 1, 2010
Last Updated
December 9, 2020
Record last verified: 2011-12