Investigation of Mass Balance of the Test Drug and Major Metabolites

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432302
• Other study ID #: 91490
• Secondary ID: 2006-000188-2631
• Status: Completed
• Phase: Phase 1
• First received: February 6, 2007
• Last updated: December 10, 2015
• Start date: January 2007
• Est. completion date: November 2007

Study information

• Verified date: December 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPBelgium: Agence Fédérale de Contrôle Nucléaire
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		14 days	No
Primary	Cmax	Maximum plasma concentration for [14C]-ZK 219477, ZK 219477	14 days	No
Primary	tmax	Time to Cmax for [14C]-ZK 219477, ZK 219477	14 days	No
Primary	AUC	Area under the concentration time curve for [14C]-ZK 219477, ZK 219477	14 days	No
Primary	AUC(0-tlast)	AUC from administration until the last time point with measurable concentration for [14C]-ZK 219477, ZK 219477	14 days	No
Primary	AUC(0-24)	AUC from time zero to 24 hours for [14C]-ZK 219477, ZK 219477	14 days	No
Primary	MRT	Mean residence time for [14C]-ZK 219477, ZK 219477	14 days	No
Primary	t1/2	Terminal half-life for [14C]-ZK 219477, ZK 219477	14 days	No
Primary	?z	Apparent terminal rate constant for [14C]-ZK 219477, ZK 219477	14 days	No
Primary	CL	Total clearance for ZK 219477	14 days	No
Primary	Vss	Apparent volume of distribution at steady state for ZK 219477	14 days	No
Primary	Vz	Apparent volume of distribution during terminal phase for ZK 219477	14 days	No
Secondary	Number of participants with adverse events		Approximately 12 weeks to 30 weeks	Yes
Secondary	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	Approximately 10 to 32 weeks	No
Secondary	Best overall response	Overall response as obtained at all time points available for an individual subject combined to the 'best overall response'	Approximately 10 to 32 weeks	No
Secondary	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'	Approximately 10 to 32 weeks	No

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