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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00426140
First received: January 23, 2007
Last updated: April 22, 2010
Last verified: April 2010
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability will be assessed by AEs, SAEs and out of range lab values. [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
  • Radiological scans will also be completed at approximately 6 weeks to asses anti-tumor activity. [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00426140     History of Changes
Other Study ID Numbers: CEPO906A2122
Study First Received: January 23, 2007
Last Updated: April 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
EPO
Patupilone
Solid Tumors

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

ClinicalTrials.gov processed this record on July 22, 2014