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AcSé CRIZOTINIB: Crizotinib in Tumors With Specific Genomic Alterations
NCT02034981Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2013
- Primary completion
- Jun 2019
- Countries
- 1
- Sponsor
- Unicancer
- Modality
- Small Molecules
- Drugs
- crizotinib
- Conditions
- hematologic cancersolid tumormetastatic cancer
01
Overview
Phase 2, open-label, single-arm trial of crizotinib in hematologic cancer, solid tumor and metastatic cancer, sponsored by Unicancer. Primary endpoint: Efficacy of crizotinib at 8 weeks. Started Aug 2013; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
CRIZOTINIB
All eligible patients entering the study will receive oral crizotinib as monotherapy
03
Who it enrols
Patients >= 1 year old with unresectable locally advanced or metastatic malignant tumors harboring ALK, MET, RON, or ROS1 alterations, who have exhausted standard therapeutic options. Excludes NSCLC with ALK translocation and prior crizotinib treatment.
04
Endpoints
Primary
Efficacy of crizotinib
Secondary
Safety profile of crizotinib
Disease control rate
Response duration
Progression-free survival
Overall survival
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