- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00426140
Pharmacokinetics of Patupilone After a Single Intravenous Administration in Patients With Advance Solid Tumor Malignancies.
December 6, 2020 updated by: Novartis Pharmaceuticals
An Open-label Single Center Study to Characterize the Absorption, Distribution, Metabolism, and Elimination (ADME) of Patupilone (EPO906) After a Single Intravenous Administration of 10 mg/m2 [14C] Patupilone in Patients With Advanced Solid Tumor Malignancies.
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78229
- Cancer Therapy and Research Center, Institution for Drug Development
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EPO906
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To characterize the pharmacokinetic profile of patupilone including any potential metabolite(s) in blood/plasma as well as the total radioactivity in blood and plasma.
Time Frame: one week
|
one week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability will be assessed by AEs, SAEs and out of range lab values.
Time Frame: every 6 weeks
|
every 6 weeks
|
Radiological scans will also be completed at approximately 6 weeks to asses anti-tumor activity.
Time Frame: every 6 weeks
|
every 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
November 1, 2006
Study Registration Dates
First Submitted
January 23, 2007
First Submitted That Met QC Criteria
January 23, 2007
First Posted (Estimate)
January 24, 2007
Study Record Updates
Last Update Posted (Actual)
December 8, 2020
Last Update Submitted That Met QC Criteria
December 6, 2020
Last Verified
April 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEPO906A2122
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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