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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

January 9, 2007
January 9, 2012
May 2006
February 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • Safety and tolerability in patients with hepatic impairment will be assessed by AEs, SAEs and out of range lab values.
  • Radiological scans will also be completed approximately every 6 weeks to asses anti-tumor activity.
Complete list of historical versions of study NCT00421044 on ClinicalTrials.gov Archive Site
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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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Advanced Malignancies
  • Tumors
Drug: Patupilone/EPO906
  • Experimental: Arm A (Normal liver function)
    Intervention: Drug: Patupilone/EPO906
  • Experimental: Arm B (Mild liver dysfunction)
    Intervention: Drug: Patupilone/EPO906
  • Experimental: Arm C (Moderate liver dysfunction)
    Intervention: Drug: Patupilone/EPO906
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
Not Provided
February 2008   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00421044
CEPO906A2121E1
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
Novartis
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP