Trial Condition(s):
Small Cell Lung Carcinoma
Safety and efficacy study of a new chemotherapy agent to treat small cell lung cancer
Bayer Identifier:
91375
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Großhansdorf, Germany, 22927 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 21075 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Löwenstein, Germany, 74245 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Halle, Germany, 06120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Response to treatment according to the modRECIST (complete response or partial response)Timeframe: Every 2 cycles until tumor progression i.e. approximately every 6 weeks
Secondary Outcome
- Duration of complete or partial tumor responseTimeframe: Every 2 cycles until tumor progression i.e. approximately every 6 weeks
- Time to tumor progressionTimeframe: Every 2 cycles until tumor progression i.e. approximately every 6 weeks
- Number of participants with adverse eventsTimeframe: Approximately 30 weeks
Additional Information
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