Investigation of Mass Balance of the Test Drug and Major Metabolites

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00432302
Recruitment Status : Completed
First Posted : February 7, 2007
Last Update Posted : December 14, 2015
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Neoplasms Drug: Sagopilone (BAY 86-5302, ZK 219477) Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]
  2. Cmax [ Time Frame: 14 days ]
    Maximum plasma concentration for [14C]-ZK 219477, ZK 219477

  3. tmax [ Time Frame: 14 days ]
    Time to Cmax for [14C]-ZK 219477, ZK 219477

  4. AUC [ Time Frame: 14 days ]
    Area under the concentration time curve for [14C]-ZK 219477, ZK 219477

  5. AUC(0-tlast) [ Time Frame: 14 days ]
    AUC from administration until the last time point with measurable concentration for [14C]-ZK 219477, ZK 219477

  6. AUC(0-24) [ Time Frame: 14 days ]
    AUC from time zero to 24 hours for [14C]-ZK 219477, ZK 219477

  7. MRT [ Time Frame: 14 days ]
    Mean residence time for [14C]-ZK 219477, ZK 219477

  8. t1/2 [ Time Frame: 14 days ]
    Terminal half-life for [14C]-ZK 219477, ZK 219477

  9. λz [ Time Frame: 14 days ]
    Apparent terminal rate constant for [14C]-ZK 219477, ZK 219477

  10. CL [ Time Frame: 14 days ]
    Total clearance for ZK 219477

  11. Vss [ Time Frame: 14 days ]
    Apparent volume of distribution at steady state for ZK 219477

  12. Vz [ Time Frame: 14 days ]
    Apparent volume of distribution during terminal phase for ZK 219477

Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Approximately 12 weeks to 30 weeks ]
  2. Overall response [ Time Frame: Approximately 10 to 32 weeks ]
    Determination of complete response (CR), partial response (PR), unknown, stable disease, progressive disease (PD) by the modified Response Evaluation Criteria in Solid Tumors

  3. Best overall response [ Time Frame: Approximately 10 to 32 weeks ]
    Overall response as obtained at all time points available for an individual subject combined to the 'best overall response'

  4. Responders [ Time Frame: Approximately 10 to 32 weeks ]
    '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'

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00432302

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

Additional Information:
Responsible Party: Bayer Identifier: NCT00432302     History of Changes
Other Study ID Numbers: 91490
2006-000188-26 ( EudraCT Number )
310301 ( Other Identifier: Company Internal )
First Posted: February 7, 2007    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015

Keywords provided by Bayer:
Mass Balance
Cancer Treatment
Intravenous Infusion
Solid Tumor

Additional relevant MeSH terms:
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents