Phase 2 Study Assessing Efficacy and Safety of Crizotinib in Patients Harboring an Alteration on ALK, MET or ROS1
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 470
Summary
- Conditions
- Hematologic Cancers
- Metastatic Cancer
- Solid Tumors
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 1 years and 125 years
- Gender
- Both males and females
Description
Twenty cohorts are identified, a cohort being defined as [one pathology, one target alteration] such as [gastric cancer with MET amplification (6%)]. One cohort will be dedicated to miscellaneous, very rare pediatric diseases identified through INCa platforms or pan-genome programs (e.g. MOSKIDO, IG...
Twenty cohorts are identified, a cohort being defined as [one pathology, one target alteration] such as [gastric cancer with MET amplification (6%)]. One cohort will be dedicated to miscellaneous, very rare pediatric diseases identified through INCa platforms or pan-genome programs (e.g. MOSKIDO, IGR) and will recruit up to 10 patients. Two cohorts will be dedicated to a couple of diseases harbouring at least one specific alteration in one crizotinib target, same or different from those listed above, e.g. in AXL gene, arising from pan-genome trials. ALCL, adults and children, ALK-translocated Colorectal cancer, adults, ALK-translocated Colorectal cancer, adults, MET amplified Colorectal cancer, adults, MET mutated NSCLC, adults, MET amplified NSCLC, adults, ROS1-translocated Breast cancer, adults, ALK-translocated Gastric cancer, adults, MET amplified Cholangiocarcinoma, adults, ROS1-translocated Ovarian cancer, adults, MET amplified Clear cell renal cell carcinoma, adults, ALK-translocated Clear cell renal cell carcinoma, adults, ALK-amplified Papillary renal cell carcinoma, adults, MET mutated (+ MET amplified) Hepatocarcinoma, adults, MET amplified Neuroblastoma, adults and children, ALK-amplified + ALK mutated IMT, adults and children, ALK-translocated Rhabdomyosarcoma (alveolar and embryonal), adults and children, ALK-amplified Glioblastoma, adults, MET amplified. This cohort will only be open after amendment Anaplastic thyroid cancer, adults, ALK mutated Thyroid cancer (follicular + medullary + papillary), adults, MET mutated Miscellaneous rare pediatric diseases associated to at least one specific alteration in one crizotinib target, same or different from those listed above One another pathology associated to at least one specific alteration in one crizotinib target, same or different from those listed above. One another pathology associated to at least one specific alteration in one crizotinib target, same or different from those listed above.
Tracking Information
- NCT #
- NCT02034981
- Collaborators
- National Cancer Institute, France
- Fondation ARC
- Pfizer
- Investigators
- Principal Investigator: Gilles VASSAL Gustave Roussy, Villejuif