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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Brief Summary

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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

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Detailed Description

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Conditions

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Advanced Malignancies Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EPO906

Group Type EXPERIMENTAL

Patupilone

Intervention Type DRUG

Interventions

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Patupilone

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No