Status:
COMPLETED
Pharmacokinetics of Patupilone After a Single Intravenous Administration in Patients With Advance Solid Tumor Malignancies.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced Malignancies
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 mal...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00426140
Start Date
August 1 2006
Last Update
December 8 2020
Active Locations (1)
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1
Cancer Therapy and Research Center, Institution for Drug Development
San Antonio, Texas, United States, 78229