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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.


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Malignancies, Solid Tumors

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Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

one week

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CEPO906A2122

NCT ID:

NCT00426140

Start Date:

August 2006

Completion Date:

Related Keywords:

  • Advanced Malignancies
  • Solid Tumors
  • EPO
  • Patupilone
  • Solid Tumors
  • Neoplasms

Name

Location

Cancer Therapy and Research Center, Institution for Drug DevelopmentSan Antonio, Texas  78229