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.
Information provided by:
Bayer Identifier:
First received: February 6, 2007
Last updated: June 19, 2013
Last verified: June 2013
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
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

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)

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00432302

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

Additional Information:
No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer Healthcare AG Identifier: NCT00432302     History of Changes
Other Study ID Numbers: 91490, 2006-000188-26, 310301
Study First Received: February 6, 2007
Last Updated: June 19, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Belgium: Agence Fédérale de Contrôle Nucléaire

Keywords provided by Bayer:
Mass Balance
Cancer Treatment
Intravenous Infusion
Solid Tumor processed this record on November 25, 2015