Skip to main content
OpenTrials
Completed

NCT Number: NCT00420524

A Study 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Malignancies Neoplasms Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California San Diego/Moores Cancer Center, La Jolla, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patupilone/EPO906

Drug

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. To correlate the level of hepatic dysfunction to observed toxicity and pharmacokinetics

    Time frame: After completion of the study (approximately 6 weeks from treatment)

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2010
First posted
Jan 11, 2007
Registry last updated
Dec 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.