check_circleStudy Completed

Neoplasms

Bayer Identifier:

91490

ClinicalTrials.gov Identifier:

NCT00432302

EudraCT Number:

2006-000188-26

EU CT Number:

Not Available
investigation of mass balance of the test drug and major metabolites

Trial 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

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - Concurrent severe and/or uncontrolled disease
    - Brain tumors
    - Marked constipation

Trial summary

Enrollment Goal
7
Trial Dates
January 2007 - November 2007
Phase
Phase 1
Could I Receive a placebo
No
Products
Sagopilone (BAY86-5302)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
CHC Clinique Saint-JosephLIEGE, 4000, Belgium

Primary Outcome

  • 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.
    date_rangeTime Frame:
    14 days
    enhanced_encryption
    Safety Issue:
    no
  • Cmax
    Maximum plasma concentration for [14C]-ZK 219477, ZK 219477
    date_rangeTime Frame:
    14 days
    enhanced_encryption
    Safety Issue:
    No
  • tmax
    Time to Cmax for [14C]-ZK 219477, ZK 219477
    date_rangeTime Frame:
    14 days
    enhanced_encryption
    Safety Issue:
    No
  • AUC
    Area under the concentration time curve for [14C]-ZK 219477, ZK 219477
    date_rangeTime Frame:
    14 days
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tlast)
    AUC from administration until the last time point with measurable concentration for [14C]-ZK 219477, ZK 219477
    date_rangeTime Frame:
    14 days
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-24)
    AUC from time zero to 24 hours for [14C]-ZK 219477, ZK 219477
    date_rangeTime Frame:
    14 days
    enhanced_encryption
    Safety Issue:
    No
  • MRT
    Mean residence time for [14C]-ZK 219477, ZK 219477
    date_rangeTime Frame:
    14 days
    enhanced_encryption
    Safety Issue:
    No
  • t1/2
    Terminal half-life for [14C]-ZK 219477, ZK 219477
    date_rangeTime Frame:
    14 days
    enhanced_encryption
    Safety Issue:
    No
  • λz
    Apparent terminal rate constant for [14C]-ZK 219477, ZK 219477
    date_rangeTime Frame:
    14 days
    enhanced_encryption
    Safety Issue:
    No
  • CL
    Total clearance for ZK 219477
    date_rangeTime Frame:
    14 days
    enhanced_encryption
    Safety Issue:
    No
  • Vss
    Apparent volume of distribution at steady state for ZK 219477
    date_rangeTime Frame:
    14 days
    enhanced_encryption
    Safety Issue:
    No
  • Vz
    Apparent volume of distribution during terminal phase for ZK 219477
    date_rangeTime Frame:
    14 days
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of participants with adverse events
    date_rangeTime Frame:
    Approximately 12 weeks to 30 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Overall response
    Determination of complete response (CR), partial response (PR), unknown, stable disease, progressive disease (PD) by the modified Response Evaluation Criteria in Solid Tumors
    date_rangeTime Frame:
    Approximately 10 to 32 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Best overall response
    Overall response as obtained at all time points available for an individual subject combined to the ‘best overall response’
    date_rangeTime Frame:
    Approximately 10 to 32 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Responders
    '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'
    date_rangeTime Frame:
    Approximately 10 to 32 weeks
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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