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

Phase 1

Completed

• Conditions: Solid Tumors; Advanced Malignancies
• Interventions: Drug: Patupilone

• Registration Number: NCT00426140
• Lead Sponsor: Novartis Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2006-11
• Study First Submitted: 2007-01-23
• Study First Submitted QC: 2007-01-23
• Study First Posted: 2007-01-24
• Status Verified: 2010-04
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EPO906	Patupilone	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Cancer Therapy and Research Center, Institution for Drug Development; 🇺🇸 San Antonio, Texas, United States