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

Completed · Phase 1

Conditions studied: Advanced Malignancies, Solid Tumors

In brief

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

Key facts

Study ID

NCT00426140

Run by

Novartis Pharmaceuticals

People needed

5

Starts

2006-08-01

Last updated by the study team

2020-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cancer Therapy and Research Center, Institution for Drug Development — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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