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

Solid Tumors Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426140
• Other study ID #: CEPO906A2122
• Status: Completed
• Phase: Phase 1
• Start date: August 2006

Study information

• Verified date: April 2010
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Malignancies
• Neoplasms
• Solid Tumors

Intervention

Drug:
• Patupilone

Locations

Country	Name	City	State
United States	Cancer Therapy and Research Center, Institution for Drug Development	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety and tolerability will be assessed by AEs, SAEs and out of range lab values.		every 6 weeks
Secondary	Radiological scans will also be completed at approximately 6 weeks to asses anti-tumor activity.		every 6 weeks

External Links

•   Results can be found for CEPO906A2122 on the Novartis Clinical Trial Results Website