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

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ClinicalTrials.gov Identifier: NCT00299390
Recruitment Status : Terminated (Since only 1 of the first 10 subjects responded to the study treatment, it was decided to stop the trial due to lack of efficacy .)
First Posted : March 6, 2006
Last Update Posted : December 31, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Small Cell Lung Carcinoma Drug: Sagopilone (BAY86-5302, ZK 219477) Phase 2

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  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : April 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00299390


Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00299390     History of Changes
Other Study ID Numbers: 91375
2005-000597-53 ( EudraCT Number )
307972
First Posted: March 6, 2006    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: December 2015

Keywords provided by Bayer:
Sagopilone
Epothilone
SCLC
Small Cell Lung Cancer
Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Epothilones
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents