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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Epothilone B; Epothilones

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.