Investigation of Mass Balance of the Test Drug and Major Metabolites

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: February 6, 2007
Last updated: December 10, 2015
Last verified: December 2015
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: Sagopilone (BAY 86-5302, ZK 219477)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics 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 ]
  • Cmax [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Maximum plasma concentration for [14C]-ZK 219477, ZK 219477

  • tmax [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Time to Cmax for [14C]-ZK 219477, ZK 219477

  • AUC [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Area under the concentration time curve for [14C]-ZK 219477, ZK 219477

  • AUC(0-tlast) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    AUC from administration until the last time point with measurable concentration for [14C]-ZK 219477, ZK 219477

  • AUC(0-24) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    AUC from time zero to 24 hours for [14C]-ZK 219477, ZK 219477

  • MRT [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Mean residence time for [14C]-ZK 219477, ZK 219477

  • t1/2 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Terminal half-life for [14C]-ZK 219477, ZK 219477

  • λz [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Apparent terminal rate constant for [14C]-ZK 219477, ZK 219477

  • CL [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Total clearance for ZK 219477

  • Vss [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Apparent volume of distribution at steady state for ZK 219477

  • Vz [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Apparent volume of distribution during terminal phase for ZK 219477

Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Approximately 12 weeks to 30 weeks ] [ Designated as safety issue: Yes ]
  • Overall response [ Time Frame: Approximately 10 to 32 weeks ] [ Designated as safety issue: No ]
    Determination of complete response (CR), partial response (PR), unknown, stable disease, progressive disease (PD) by the modified Response Evaluation Criteria in Solid Tumors

  • Best overall response [ Time Frame: Approximately 10 to 32 weeks ] [ Designated as safety issue: No ]
    Overall response as obtained at all time points available for an individual subject combined to the 'best overall response'

  • Responders [ Time Frame: Approximately 10 to 32 weeks ] [ Designated as safety issue: No ]
    'Response' was considered to be established if 'Best overall response' of PR or CR was confirmed at any time after the start of study treatment. If response was established, a subject was referred to as a 'responder'

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: Sagopilone
Subjects received 28 mg ZK 219477, containing 14 kBq/7.8 µg [14C]-ZK 219477 in the first infusion (Treatment course 1) followed by subsequent infusions (Treatment courses 2 to n [till disease progression]) of 16 mg/m2 ZK 219477 without radioactive label. Interval between the treatments was at least 21 days.
Drug: Sagopilone (BAY 86-5302, ZK 219477)
First infusion only: 28 mg, containing 14 kBq/7.8 mcg [14C]-ZK 219477. Subsequent infusions: 16 mg/m2 ZK 219477 without radioactive label. IV infusion was given over a period of 30 min.

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:

  • Male ≥ 18 years; female ≥ 50 years without childbearing potential (confirmed by either: age ≥ 60; or history of hysterectomy; or hormone analysis in serum: Estradiol ≤ 20 pg/mL and follicle stimulating hormone ≥ 40 IU/L)
  • 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
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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:
Responsible Party: Bayer Identifier: NCT00432302     History of Changes
Other Study ID Numbers: 91490  2006-000188-26  310301 
Study First Received: February 6, 2007
Last Updated: December 10, 2015
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 May 24, 2016