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Simvastatin with Irinotecan/Cisplatin in SCLC
NCT01441349Phase 2
Key facts
- Status
- Unknown
- Start
- Aug 2011
- Primary completion
- Oct 2022
- Countries
- 1
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Modality
- Small Molecules
- Drugs
- simvastatin
- Conditions
- small cell lung cancer (SCLC)
01
Overview
Phase 2, randomised, open-label trial of simvastatin in small cell lung cancer (SCLC) (2 arms), sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Primary endpoint: 1-year survival rate. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
IP Chemotherapy
Irinotecan + Cisplatin
IP + Simvastatin
Irinotecan + Cisplatin + Simvastatin
03
Who it enrols
Chemo-naive patients with Extensive Disease Small Cell Lung Cancer who are ever smokers (>100 cigarettes lifetime) and have adequate organ function. Patients taking simvastatin or with contraindications to it are excluded.
04
Endpoints
Primary
1-year survival rate
Secondary
Tumor Response rate
Progression free survival
Toxicity profile
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