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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00426140

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Aug 1, 2006

Actual Primary Completion Date :

Nov 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EPO906	Drug: Patupilone

Arm

Intervention/Treatment

Experimental: EPO906

Drug: Patupilone

Outcome Measures

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. [one week]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.