An open-label, randomised, phase II study in subjects with extensive disease, small cell lung cancer (ED-SCLC) after an initial response (complete response or partial response) to platinum-based therapy to determine the effect of EMD 273066 following low-dose cyclophosphamide on disease progression and survival versus best supportive care alone.
- Conditions
- Small cell lung cancer
- Registration Number
- EUCTR2006-004566-13-DE
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 110
- Signed written informed consent
- >18 years of age
- Histologically documented SCLC
- Radiologically demonstrated extensive-stage disease by thoracic and abdominal CT or MRI scan prior to induction chemotherapy.
- Received 4 cycles of platium-based, first-line chemotherapy (12-14) weeks) without thoracic irradiation.
- Experienced a response to platium-based first-line chemotherapy (CR or PR according to RECIST shown after second and fourth course of induction chemotherapy compared to findings prior to induction therapy.
- Confirmatory CT or MRI scan
- Negative CT of the head.
- Be enrolled and begin treatment 3-5 weeks after last infusion of platium-based, first-line chemotherapy.
- Life expectancy > 4 months
-ECOG performance status < 2 at study entry
etc
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Thoracic radiotherapy, surgery (excluding prior diagnostic biopsyI or any investigational drug in the 30 days before the start of treatment in this study.
- ECG with evidence of active clinically significant cardiac disease within 4 weeks prior to starting study treatment.
- Uncontrolled CHF New York Heart Association Grade 2-4 or echocardiogram with a left ventricular ejection fraction < 45%
- History or repeated and clinically relevant episodes of syncope or other paroxysmal, ventricular or other clinically significant arrhytmias.
- Uncontrolled hypertension
- Evidence of active brain metastases.
etc
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method