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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00421044
Recruitment Status : Completed
First Posted : January 11, 2007
Last Update Posted : January 11, 2012
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
Patients who participated in the core EPO2121 study and did not clinically progress may participate in this extension protocol to further evaluate the safety, tolerability, and efficacy of patupilone.

Condition or disease Intervention/treatment Phase
Advanced Malignancies Tumors Drug: Patupilone/EPO906 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2006
Actual Primary Completion Date : February 2008

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

Primary Outcome Measures :
  1. 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: at completion of the study ]
  2. To evaluate the preliminary anti-tumor activity which will be assessed by radiological scans every 6 weeks [ Time Frame: at completion of the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Completion of the core study is required for participation in the extension.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00421044

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

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00421044     History of Changes
Obsolete Identifiers: NCT00478920
Other Study ID Numbers: CEPO906A2121E1
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: January 11, 2012
Last Verified: January 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Solid Tumors

Additional relevant MeSH terms:
Epothilone B
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action