NCT00160069

Brief Summary

Phase 2 study to investigate the efficacy and tolerability of epothilone ZK 219477 in patients with stage IIIb or stage IV non-small-cell lung cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2005

Typical duration for phase_2

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

2.7 years

First QC Date

September 8, 2005

Last Update Submit

December 2, 2014

Conditions

Carcinoma, Non Small Cell Lung

Keywords

Stage IIIB or stage IV non-small-cell lung cancer.

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy variable is defined as Proportion of patients with either CR or PR as 'best overall response'. Tumor assessment is performed according to RECIST criteria.

    Tumor evaluation (MRI or scan) every 2 cycles until disease progression.

Secondary Outcomes (1)

  • Secondary objectives : investigate the safety and tolerability of ZK 219477

    Continuously

Study Arms (3)

Arm 1

EXPERIMENTAL
Drug: Sagopilone (BAY86-5302, ZK 219477)

Arm 2

EXPERIMENTAL
Drug: Sagopilone (BAY86-5302, ZK 219477)

Arm 3

EXPERIMENTAL
Drug: Sagopilone (BAY86-5302, ZK 219477)

Interventions

Sagopilone (BAY86-5302, ZK 219477)DRUG

16 mg/m2, 3-hour infusion, every 3 weeks

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-small-cell lung cancer
  • Only one previous chemotherapy with a platinum-containing drug
  • Use of highly effective birth control methods in females of child-bearing potential

You may not qualify if:

  • No more than 1 previous chemotherapy for advanced disease
  • Previous participation in another trial within the last 4 weeks
  • Breast feeding
  • Active infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

Löwenstein, Baden-Wurttemberg, 74245, Germany

Location

Unknown Facility

Augsburg, Bavaria, 86156, Germany

Location

Unknown Facility

Gauting, Bavaria, 82131, Germany

Location

Unknown Facility

Nuremberg, Bavaria, 90419, Germany

Location

Unknown Facility

Hamburg, Hamburg, 21075, Germany

Location

Unknown Facility

Frankfurt am Main, Hesse, 60590, Germany

Location

Unknown Facility

Frankfurt am Main, Hesse, 65929, Germany

Location

Unknown Facility

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Unknown Facility

Stralsund, Mecklenburg-Vorpommern, 17475, Germany

Location

Unknown Facility

Leipzig, Saxony, 04103, Germany

Location

Unknown Facility

Halle, Saxony-Anhalt, 06120, Germany

Location

Unknown Facility

Magdeburg, Saxony-Anhalt, 39130, Germany

Location

Unknown Facility

Großhansdorf, Schleswig-Holstein, 22927, Germany

Location

Unknown Facility

Berlin, State of Berlin, 12200, Germany

Location

Unknown Facility

Berlin, State of Berlin, 14165, Germany

Location

Unknown Facility

Bremen, 29325, Germany

Location

Unknown Facility

Ebensfeld, 96250, Germany

Location

Related Publications (1)

  • Heigener DF, von Pawel J, Eschbach C, Brune A, Schmittel A, Schmelter T, Reck M, Fischer JR. Prospective, multicenter, randomized, independent-group, open-label phase II study to investigate the efficacy and safety of three regimens with two doses of sagopilone as second-line therapy in patients with stage IIIB or IV non-small-cell lung cancer. Lung Cancer. 2013 Jun;80(3):319-25. doi: 10.1016/j.lungcan.2013.02.007. Epub 2013 Mar 20.

    PMID: 23522488RESULT

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sagopilone

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

August 1, 2005

Primary Completion

April 1, 2008

Study Completion

April 1, 2009

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

DE(17)