Investigation of Mass Balance of the Test Drug and Major Metabolites

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

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

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Drug: Sagopilone (BAY 86-5302, ZK 219477)

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
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Liege, Belgium, 4000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Cmax	Maximum plasma concentration for [14C]-ZK 219477, ZK 219477	14 days
tmax	Time to Cmax for [14C]-ZK 219477, ZK 219477	14 days
AUC	Area under the concentration time curve for [14C]-ZK 219477, ZK 219477	14 days
AUC(0-tlast)	AUC from administration until the last time point with measurable concentration for [14C]-ZK 219477, ZK 219477	14 days
AUC(0-24)	AUC from time zero to 24 hours for [14C]-ZK 219477, ZK 219477	14 days
MRT	Mean residence time for [14C]-ZK 219477, ZK 219477	14 days
t1/2	Terminal half-life for [14C]-ZK 219477, ZK 219477	14 days
λz	Apparent terminal rate constant for [14C]-ZK 219477, ZK 219477	14 days
CL	Total clearance for ZK 219477	14 days
Vss	Apparent volume of distribution at steady state for ZK 219477	14 days
Vz	Apparent volume of distribution during terminal phase for ZK 219477	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events		Approximately 12 weeks to 30 weeks
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
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
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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: February 6, 2007
• First Submitted That Met QC Criteria: February 6, 2007
• First Posted (Estimate): February 7, 2007

Study Record Updates

• Last Update Posted (Estimate): December 14, 2015
• Last Update Submitted That Met QC Criteria: December 10, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Cancer; Chemotherapy; Solid Tumor; Malignancy; Tumor; Drug; Mass Balance; Intravenous Infusion; Cancer Treatment; Epothilone
• Additional Relevant MeSH Terms: Antineoplastic Agents; Sagopilone
• Other Study ID Numbers: 91490; 2006-000188-26 (EudraCT Number); 310301 (Other Identifier: Company Internal)