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Pharmacokinetics of Patupilone After a Single Intravenous Administration in Patients With Advance Solid Tumor Malignancies.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00426140
First Posted: January 24, 2007
Last Update Posted: April 23, 2010
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.
Information provided by:
Novartis
  Purpose
The main purpose of this study is to characterize the distribution, metabolism, and elimination (ADME) of Patupilone after a single intravenous administration in patients with advanced solid tumor malignancies

Condition Intervention Phase
Advanced Malignancies Solid Tumors Drug: Patupilone Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Single Center Study to Characterize the Absorption, Distribution, Metabolism, and Elimination (ADME) of Patupilone (EPO906) After a Single Intravenous Administration of 10 mg/m2 [14C] Patupilone in Patients With Advanced Solid Tumor Malignancies.

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To characterize the pharmacokinetic profile of patupilone including any potential metabolite(s) in blood/plasma as well as the total radioactivity in blood and plasma. [ Time Frame: one week ]

Secondary Outcome Measures:
  • Safety and tolerability will be assessed by AEs, SAEs and out of range lab values. [ Time Frame: every 6 weeks ]
  • Radiological scans will also be completed at approximately 6 weeks to asses anti-tumor activity. [ Time Frame: every 6 weeks ]

Enrollment: 5
Study Start Date: August 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EPO906 Drug: Patupilone

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. 18 years or older
  2. 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.
  3. Adequate hematological laboratory parameters
  4. No major impairment of renal or hepatic function
  5. Female patients must have a negative serum pregnancy test at screening.

Exclusion Criteria:

  1. Severe and/or uncontrolled medical disease;
  2. Severe cardiac insufficiency with uncontrolled and/or unstable cardiac or coronary artery disease;
  3. Known diagnosis of human immunodeficiency virus (HIV) infection;
  4. Presence of any other active or suspected acute or chronic uncontrolled infection;
  5. Symptomatic brain metastases or leptomeningeal disease.

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00426140


Locations
United States, Texas
Cancer Therapy and Research Center, Institution for Drug Development
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00426140     History of Changes
Other Study ID Numbers: CEPO906A2122
First Submitted: January 23, 2007
First Posted: January 24, 2007
Last Update Posted: April 23, 2010
Last Verified: April 2010

Keywords provided by Novartis:
EPO
Patupilone
Solid Tumors

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