Investigation of Mass Balance of the Test Drug and Major Metabolites

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00432302
First received: February 6, 2007
Last updated: December 10, 2015
Last verified: December 2015
  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
Neoplasms
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.
  Eligibility

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

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
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 ClinicalTrials.gov identifier: NCT00432302

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov 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:
Cancer
Tumor
Malignancy
Mass Balance
Chemotherapy
Drug
Cancer Treatment
Intravenous Infusion
Epothilone
Solid Tumor

ClinicalTrials.gov processed this record on February 04, 2016