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OpenTrials
Completed

NCT Number: NCT00426140

Pharmacokinetics of Patupilone After a Single Intravenous Administration in Patients With Advance 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cancer Therapy and Research Center, Institution for Drug Development

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patupilone

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. Safety and tolerability will be assessed by AEs, SAEs and out of range lab values.

    Time frame: every 6 weeks

  2. Radiological scans will also be completed at approximately 6 weeks to asses anti-tumor activity.

    Time frame: every 6 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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.

Important dates

Study start
2006
Primary completion
2006
First posted
Jan 24, 2007
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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