NCT02034981

Phase 2 Study Assessing Efficacy and Safety of Crizotinib in Patients Harboring an Alteration on ALK, MET or ROS1

AcSé CRIZOTINIB : Secured Access to Crizotinib for Patients With Tumors Harboring a Genomic Alteration on One of the Biological Targets of the Drug.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

This is a biology driven, trans-tumoral, multicentric phase II trial assessing the efficacy and the safety of the targeted agent crizotinib as a monotherapy in 23 cohorts of patients with identified activating molecular alterations in the crizotinib target genes. A cohort is defined by a pathology and a crizotinib-target alteration (eg gastric cancer with MET amplification). For each cohort a two-stage design will be implemented. In the situation where expected accrual allows for a sufficient number of patients to be accrued, the alpha and beta errors will be fixed at 10%. However, in very rare diseases, such as inflammatory myofibroblastic tumor (IMT), neuroblastoma, glioblastoma, and rhabdomyosarcoma (RMS), it is anticipated that the target number may not be achievable in a reasonable timeframe; for these cohorts, the alpha and beta errors will be fixed at 15%. Consequently three different statistical designs will be a priori considered according to the expected response rate and incidence.

Detailed 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, 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. 1. ALCL, adults and children, ALK-translocated 2. Colorectal cancer, adults, ALK-translocated 3. Colorectal cancer, adults, MET amplified 4. Colorectal cancer, adults, MET mutated 5. NSCLC, adults, MET amplified 6. NSCLC, adults, ROS1-translocated 7. Breast cancer, adults, ALK-translocated 8. Gastric cancer, adults, MET amplified 9. Cholangiocarcinoma, adults, ROS1-translocated 10. Ovarian cancer, adults, MET amplified 11. Clear cell renal cell carcinoma, adults, ALK-translocated 12. Clear cell renal cell carcinoma, adults, ALK-amplified 13. Papillary renal cell carcinoma, adults, MET mutated (+ MET amplified) 14. Hepatocarcinoma, adults, MET amplified 15. Neuroblastoma, adults and children, ALK-amplified + ALK mutated 16. IMT, adults and children, ALK-translocated 17. Rhabdomyosarcoma (alveolar and embryonal), adults and children, ALK-amplified 18. Glioblastoma, adults, MET amplified. This cohort will only be open after amendment 19. Anaplastic thyroid cancer, adults, ALK mutated 20. Thyroid cancer (follicular + medullary + papillary), adults, MET mutated 21. Miscellaneous rare pediatric diseases associated to at least one specific alteration in one crizotinib target, same or different from those listed above 22. One another pathology associated to at least one specific alteration in one crizotinib target, same or different from those listed above. 23. One another pathology associated to at least one specific alteration in one crizotinib target, same or different from those listed above.

Conditions

• Hematologic Cancers
• Solid Tumors
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	Crizotinib	Patients will receive oral crizotinib, daily continuously, until progression or unacceptable toxicity develops. -250 mg twice daily for adults ≥ 18 years of age * 280 mg/m² twice daily for children and adolescents aged from 1 to 17 (except ALCL). * 165 mg/m² twice daily for ALCL patients aged from 1 to 17.

Timeline

• Start date: 2013-08-01
• Primary completion: 2019-06-01
• Completion: 2023-12-06
• First posted: 2014-01-14
• Last updated: 2024-02-28

Locations

1 site across 1 country: France