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

Novartis

Status and phase: Completed; Phase 1

Conditions: Advanced Malignancies; Solid Tumors

Treatments: Drug: Patupilone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00426140

CEPO906A2122

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

EPO906

Experimental group

Treatment:

Drug: Patupilone