Safety and Efficacy Study of a New Chemotherapy Agent to Treat Small Cell Lung Cancer
NCT ID: NCT00299390
Last Updated: 2015-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
10 participants
INTERVENTIONAL
2006-04-30
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sagopilone
Sagopilone (BAY86-5302, ZK 219477)
Sagopilone; 16 mg/m2 (maximum 32 mg) as 3 hour i.v. infusion
Interventions
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Sagopilone (BAY86-5302, ZK 219477)
Sagopilone; 16 mg/m2 (maximum 32 mg) as 3 hour i.v. infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Countries
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Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Other Identifiers
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2005-000597-53
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
307972
Identifier Type: -
Identifier Source: secondary_id
91375
Identifier Type: -
Identifier Source: org_study_id