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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00420524
First received: January 9, 2007
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Advanced Malignancies
Tumors
Drug: Patupilone/EPO906
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To assess the effect of hepatic impairment on the pharmacokinetics of patupilone and its metabolite [ Time Frame: After completion of the study (approximately 6 weeks from treatment) ] [ Designated as safety issue: Yes ]
  • To determine the maximum tolerated dose of patupilone in patients with hepatic impairment [ Time Frame: After completion of the study (approximately 6 weeks from treatment) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To correlate the level of hepatic dysfunction to observed toxicity and pharmacokinetics [ Time Frame: After completion of the study (approximately 6 weeks from treatment) ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: After completion of the study (approximately 6 weeks from treatment) ] [ Designated as safety issue: Yes ]
  • To evaluate the preliminary anti-tumor activity which will be assessed by radiological scans every 6 weeks [ Time Frame: After completion of the study (approximately 6 weeks from treatment) ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: January 2006
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420524

Locations
United States, California
University of California San Diego/Moores Cancer Center
La Jolla, California, United States, 92093-0987
United States, New Mexico
Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131-5636
United States, Texas
Institute for Drug Development Cancer Therapy & Research Center/The University of Texas Health Science
San Antonio, Texas, United States, 78229
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00420524     History of Changes
Other Study ID Numbers: CEPO906A2121
Study First Received: January 9, 2007
Last Updated: December 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
EPO
Patupilone
Solid Tumors

Additional relevant MeSH terms:
Neoplasms
Epothilone B
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014