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

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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:

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

Exclusion Criteria:

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

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

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

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 May 16, 2013