Study Stopped
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 .
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Small Cell Lung Cancer
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)
3 other identifiers
interventional
10
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2006
Shorter than P25 for phase_2
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
First Submitted
Initial submission to the registry
March 3, 2006
CompletedFirst Posted
Study publicly available on registry
March 6, 2006
CompletedStudy Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedDecember 31, 2015
December 1, 2015
1 year
March 3, 2006
December 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response to treatment according to the modRECIST (complete response or partial response)
Every 2 cycles until tumor progression i.e. approximately every 6 weeks
Secondary Outcomes (3)
Duration of complete or partial tumor response
Every 2 cycles until tumor progression i.e. approximately every 6 weeks
Time to tumor progression
Every 2 cycles until tumor progression i.e. approximately every 6 weeks
Number of participants with adverse events
Approximately 30 weeks
Study Arms (1)
Sagopilone
EXPERIMENTALInterventions
Sagopilone; 16 mg/m2 (maximum 32 mg) as 3 hour i.v. infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2006
First Posted
March 6, 2006
Study Start
April 1, 2006
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
December 31, 2015
Record last verified: 2015-12