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Completed

NCT Number: NCT00432302

Investigation of Mass Balance of the Test Drug and Major Metabolites

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

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Liège, 4000, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sagopilone (BAY 86-5302, ZK 219477)

Drug

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 outcomes

  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 outcomes

  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'

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Feb 7, 2007
Registry last updated
Dec 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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