Trial Condition(s):
Neoplasms
investigation of mass balance of the test drug and major metabolites
Bayer Identifier:
91490
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations CHC Clinique Saint-Joseph LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
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.Timeframe: 14 days
- CmaxMaximum plasma concentration for [14C]-ZK 219477, ZK 219477Timeframe: 14 days
- tmaxTime to Cmax for [14C]-ZK 219477, ZK 219477Timeframe: 14 days
- AUCArea under the concentration time curve for [14C]-ZK 219477, ZK 219477Timeframe: 14 days
- AUC(0-tlast)AUC from administration until the last time point with measurable concentration for [14C]-ZK 219477, ZK 219477Timeframe: 14 days
- AUC(0-24)AUC from time zero to 24 hours for [14C]-ZK 219477, ZK 219477Timeframe: 14 days
- MRTMean residence time for [14C]-ZK 219477, ZK 219477Timeframe: 14 days
- t1/2Terminal half-life for [14C]-ZK 219477, ZK 219477Timeframe: 14 days
- λzApparent terminal rate constant for [14C]-ZK 219477, ZK 219477Timeframe: 14 days
- CLTotal clearance for ZK 219477Timeframe: 14 days
- VssApparent volume of distribution at steady state for ZK 219477Timeframe: 14 days
- VzApparent volume of distribution during terminal phase for ZK 219477Timeframe: 14 days
Secondary Outcome
- Number of participants with adverse eventsTimeframe: Approximately 12 weeks to 30 weeks
- Overall responseDetermination of complete response (CR), partial response (PR), unknown, stable disease, progressive disease (PD) by the modified Response Evaluation Criteria in Solid TumorsTimeframe: Approximately 10 to 32 weeks
- Best overall responseOverall response as obtained at all time points available for an individual subject combined to the ‘best overall response’Timeframe: Approximately 10 to 32 weeks
- 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'Timeframe: Approximately 10 to 32 weeks
Additional Information
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