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

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ClinicalTrials.gov Identifier: NCT00426140
Recruitment Status : Completed
First Posted : January 24, 2007
Last Update Posted : December 8, 2020
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Malignancies Solid Tumors Drug: Patupilone Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
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.
Study Start Date : August 2006
Actual Primary Completion Date : November 2006

Arm Intervention/treatment
Experimental: EPO906 Drug: Patupilone

Primary Outcome Measures :
  1. 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 :
  1. Safety and tolerability will be assessed by AEs, SAEs and out of range lab values. [ Time Frame: every 6 weeks ]
  2. Radiological scans will also be completed at approximately 6 weeks to asses anti-tumor activity. [ Time Frame: every 6 weeks ]

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:

  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.

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

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United States, Texas
Cancer Therapy and Research Center, Institution for Drug Development
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
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Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00426140    
Other Study ID Numbers: CEPO906A2122
First Posted: January 24, 2007    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: April 2010
Keywords provided by Novartis:
Solid Tumors
Additional relevant MeSH terms:
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Epothilone B
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action