Safety and Efficacy Study of a New Chemotherapy Agent to Treat Small Cell Lung Cancer

December 30, 2015 updated by: Bayer

Phase II Study to Investigate the Efficacy and Safety of ZK 219477 as First Line Therapy in Chemotherapy Naive Patients With Extensive Disease (ED) Stage Small Cell Lung Cancer (SCLC)

The purpose of this study is to determine whether the study drug is effective and safe in the first line treatment of patients with small cell lung cancer

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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)

10

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Histologically or cytologically proven Small-cell lung cancer (SCLC)
  • Stage of extensive disease defined by the presence of distant metastases
  • At least 1 unidimensionally measureable lesion
  • WHO performance status 0 to 1
  • No previous SCLC-related chemotherapy
  • No previous SCLC-related surgery
  • No previous radiotherapy (excepting for brain metastasis)

  • Adequate function of major organs and systems

    • Nervous system

      • No Grade 2 or greater peripheral neuropathy

    • Cardiovascular:

      • No symptomatic congestive heart failure
      • No unstable angina pectoris
      • No arrythmia needing continuous treatment
      • No other uncontrolled concurrent illness

Exclusion Criteria:

  • Superior vena cava syndrome or obstruction of any vital structure
  • Untreated malignant hypercalcemia
  • Pleural effusion as the only manifestation of disease
  • Extensive disease amenable to radiation therapy
  • Symptomatic brain metastases requiring whole brain irradiation
  • Any concomitant malignancy excepting non-melanoma skin cancer or carcinoma in situ of the cervix

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sagopilone
Drug: Sagopilone (BAY86-5302, ZK 219477)
Sagopilone; 16 mg/m2 (maximum 32 mg) as 3 hour i.v. infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response to treatment according to the modRECIST (complete response or partial response)
Time Frame: Every 2 cycles until tumor progression i.e. approximately every 6 weeks
Every 2 cycles until tumor progression i.e. approximately every 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of complete or partial tumor response
Time Frame: Every 2 cycles until tumor progression i.e. approximately every 6 weeks
Every 2 cycles until tumor progression i.e. approximately every 6 weeks
Time to tumor progression
Time Frame: Every 2 cycles until tumor progression i.e. approximately every 6 weeks
Every 2 cycles until tumor progression i.e. approximately every 6 weeks
Number of participants with adverse events
Time Frame: Approximately 30 weeks
Approximately 30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

March 3, 2006

First Submitted That Met QC Criteria

March 3, 2006

First Posted (Estimate)

March 6, 2006

Study Record Updates

Last Update Posted (Estimate)

December 31, 2015

Last Update Submitted That Met QC Criteria

December 30, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91375
  • 2005-000597-53 (EudraCT Number)
  • 307972

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Small Cell Lung Carcinoma

Clinical Trials on Sagopilone (BAY86-5302, ZK 219477)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe