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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Malignancies; Tumors
• Intervention / Treatment: Drug: Patupilone/EPO906

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093-0987
      • University of California San Diego/Moores Cancer Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131-5636
      • Cancer Research and Treatment Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • South Texas Accelerated Research Therapeutics
    • San Antonio, Texas, United States, 78229
      • Institute for Drug Development Cancer Therapy & Research Center/The University of Texas Health Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: January 9, 2007
• First Submitted That Met QC Criteria: January 10, 2007
• First Posted (Estimate): January 11, 2007

Study Record Updates

• Last Update Posted (Actual): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 6, 2020
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Solid Tumors; EPO; Patupilone
• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Epothilone B
• Other Study ID Numbers: CEPO906A2121