EUCTR2006-004566-13-IT
Active, not recruiting
Not Applicable
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.
Conditionsextensive disease, small cell lungcancer (ED-SCLC)MedDRA version: 14.1Level: PTClassification code 10041071Term: Small cell lung cancer stage unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsENDOXAN BAXTER
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- extensive disease, small cell lungcancer (ED-SCLC)
- Sponsor
- MERCK KGaA
- Enrollment
- 110
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •? 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 platinum\-based, first\-line
- •chemotherapy (12\-14 weeks) without thoracic
- •irradiation
- •? Experienced a response to platinum\-based,
Exclusion Criteria
- •? Thoracic radiotherapy, surgery (excluding prior
- •diagnostic biopsy) or any investigational drug
- •in the 30 days before the start of treatment in
- •? ECG with evidence of active clinically
- •significant cardiac disease within 4 weeks prior
- •to starting study treatment and/or a cardiac
- •stress test with abnormal results in subjects who
- •have a history of signficant coronary heart
- •disease (MI, angina pectoris, or high risk of
- •uncontrolled arrhythmia)
Outcomes
Primary Outcomes
Not specified
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