Safety and Efficacy Study of a New Chemotherapy Agent to Treat Metastatic Breast Cancer

Prospective, Multicenter, Randomized, Independent-group, Open-label Phase II Study to Investigate the Efficacy, Safety and Tolerability of 4 Regimen With 3 Doses of ZK 219477 (16 and 12 mg/m2 Body Surface Area as 3-hour Infusion or 22 mg/m2 Body Surface Area as 30-minute or 3-hour Infusion) in Patients With Metastatic Breast Cancer

The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with metastatic breast cancer

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms; Breast Cancer, Metastatic
• Intervention / Treatment: Drug: Sagopilone (BAY86-5302, ZK 219477); Drug: Sagopilone (BAY86-5302, ZK 219477); Drug: Sagopilone (BAY86-5302, ZK 219477); Drug: Sagopilone (BAY86-5302, 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.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, 1100
  • Wien, Austria, 1090
• Belgium
  • Brasschaat, Belgium, 2930
• Bulgaria
  • Plovdiv, Bulgaria, 4001
  • Sofia, Bulgaria, 01784
  • Varna, Bulgaria, 9000
• France
  • Angers, France, 49033
  • Bordeaux, France, 33076
  • Clermont Ferrand, France, 63011
  • Saint Herblain Cedex, France, 44805
  • Vandoeuvre les Nancy, France, 54500
• Germany
  • Berlin, Germany, 10117
• Italy
  • FC
    • Forlì, FC, Italy, 47100
  • MI
    • Milano, MI, Italy, 20162
  • RE
    • Reggio Emilia, RE, Italy, 42100
• Poland
  • Olsztyn, Poland, 10-228
  • Warszawa, Poland, 02-781
• Slovenia
  • Ljubljana, Slovenia, 1000
• Spain
  • Madrid, Spain, 28040
  • Málaga, Spain, 29010
• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M20 4BX

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Metastatic breast cancer
• No previous treatment with taxanes, and vinca alkaloids
• Use of highly effective birth control methods in females of child-bearing potential

Exclusion Criteria:

• More than 2 previous chemotherapies
• Previous participation in another trial within the last 4 weeks
• Breast feeding
• Active infections

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 2; Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4)	Drug: Sagopilone (BAY86-5302, ZK 219477); 16 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.; Drug: Sagopilone (BAY86-5302, ZK 219477); 12 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.; Drug: Sagopilone (BAY86-5302, ZK 219477); 22 mg/m2, 30-minute i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.; Drug: Sagopilone (BAY86-5302, ZK 219477); 22 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
Experimental: Arm 3; Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4)	Drug: Sagopilone (BAY86-5302, ZK 219477); 16 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.; Drug: Sagopilone (BAY86-5302, ZK 219477); 12 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.; Drug: Sagopilone (BAY86-5302, ZK 219477); 22 mg/m2, 30-minute i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.; Drug: Sagopilone (BAY86-5302, ZK 219477); 22 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
Experimental: Arm 4; Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4)	Drug: Sagopilone (BAY86-5302, ZK 219477); 16 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.; Drug: Sagopilone (BAY86-5302, ZK 219477); 12 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.; Drug: Sagopilone (BAY86-5302, ZK 219477); 22 mg/m2, 30-minute i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.; Drug: Sagopilone (BAY86-5302, ZK 219477); 22 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
Experimental: Arm 1; Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4)	Drug: Sagopilone (BAY86-5302, ZK 219477); 16 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.; Drug: Sagopilone (BAY86-5302, ZK 219477); 12 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.; Drug: Sagopilone (BAY86-5302, ZK 219477); 22 mg/m2, 30-minute i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.; Drug: Sagopilone (BAY86-5302, ZK 219477); 22 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor response rate (complete or partial response according to RECIST)	The proportion of subjects with either complete or partial response according to the modified RECIST criteria was calculated as best overall response after 6 courses of therapy (i.e., before Course 7).	Every 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of complete or partial tumor response	Defined as the time between the first date that confirmed complete or partial response was established as "overall response" and the first date that recurrence or overall response of progressive disease was documented	Every 6 weeks
Time to tumor progression	Defined as the time from the start of study treatment to the first objective evidence of tumor progression, symptomatic deterioration, or death from cancer	Every 6 weeks

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: February 6, 2006
• First Submitted That Met QC Criteria: February 6, 2006
• First Posted (Estimate): February 7, 2006

Study Record Updates

• Last Update Posted (Estimate): December 2, 2014
• Last Update Submitted That Met QC Criteria: November 27, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Breast Cancer; Breast Neoplasms
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Epothilones; Sagopilone
• Other Study ID Numbers: 91464; 2005-003216-30 (EudraCT Number); 309544 (Other Identifier: Company Internal)