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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:
NCT00421044
First received: January 9, 2007
Last updated: January 9, 2012
Last verified: January 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy 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:
  • 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 ] [ Designated as safety issue: Yes ]
  • To evaluate the preliminary anti-tumor activity which will be assessed by radiological scans every 6 weeks [ Time Frame: at completion of the study ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: May 2006
Primary Completion Date: February 2008 (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:

  • 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.

  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: NCT00421044

Locations
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
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00421044     History of Changes
Obsolete Identifiers: NCT00478920
Other Study ID Numbers: CEPO906A2121E1
Study First Received: January 9, 2007
Last Updated: January 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
EPO
Patupilone
Solid Tumors

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

ClinicalTrials.gov processed this record on November 20, 2014