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Investigation Into How the Body Takes up the Test Drug and Distributes it Into Various Body Organs and Tissues, How it Processes the Drug and How it Ultimately Removes it

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00432302
First received: February 6, 2007
Last updated: July 3, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of this study is to: a) Determine how the body takes up the test drug and distributes it into various body organs and tissues, how it processes the drug and how it ultimately removes it; and b) Examine how well the test drug works against cancer, and whether it is safe and tolerable to take


Condition Intervention Phase
Tumors
 Drug: SH Y03757A (ZK 219477)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigation of Mass Balance and Major Metabolites After Administration of 28 mg Radiolabeled ZK 219477 in Patients With Solid Tumor in an Open-label, Non Randomized Design

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Blood, urine and fecal samples will be collected over a period of 336 hours (14 days) to measure 14C, ZK 219477 and its major metabolites following the intravenous administration of 14C-ZK 219477. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determination of safety, tolerability, efficacy [ Designated as safety issue: Yes ]

Enrollment: 7
Study Start Date: January 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: SH Y03757A (ZK 219477)
n/a

Detailed Description:

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Solid tumor
  • Adequate function of major organs
  • Failed previous cancer treatment
  • Peripheral venous access

Exclusion Criteria:

  • Concurrent severe and/or uncontrolled disease
  • Brain tumors
  • Marked constipation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00432302

Locations
Belgium
Liege, Belgium, 4000
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00432302     History of Changes
Other Study ID Numbers: 91490, 2006-000188-26, 310301
Study First Received: February 6, 2007
Last Updated: July 3, 2012
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines
Belgium: Agence Fédérale de Contrôle Nucléaire

Keywords provided by Bayer:
Cancer
Tumor
Malignancy
Mass Balance
Chemotherapy
 Drug
Cancer Treatment
Intravenous Infusion
Epothilone
Solid Tumor

ClinicalTrials.gov processed this record on May 19, 2013