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|Profile Name||CDKN2A mutant|
|Gene Variant Detail|
|Relevant Treatment Approaches|
|Molecular Profile||Indication/Tumor Type||Response Type||Relevant Treatment Approaches||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|CDKN2A mutant||pancreatic cancer||no benefit||Palbociclib||Phase II||Actionable||In a Phase II trial (TAPUR), patients with pancreatic cancer harboring a CDKN2A mutation or loss of CDKN2A (n=10) did not demonstrate an objective response or stable disease at 16 weeks when treated with single therapy, Ibrance (palbociclib), demonstrating a median progression-free survival of 7.2 weeks and an overall survival of 12.4 weeks (JCO Precision Oncology, Aug 14, 2019; NCT02693535).||detail...|
|CDKN2A mutant||skin melanoma||not applicable||N/A||Guideline||Risk Factor||Germline CDKN2A mutations or polymorphisms are associated with increased risk of developing single or multiple primary cutaneous melanomas (NCCN.org).||detail...|
|CDKN2A mutant||biliary tract cancer||no benefit||Palbociclib||Phase II||Actionable||In a Phase II trial (TAPUR), patients with biliary cancer harboring a CDKN2A mutation or loss of CDKN2A (n=10) did not demonstrate an objective response or stable disease at 16 weeks when treated with single therapy, Ibrance (palbociclib), demonstrating a median progression-free survival of 7.3 weeks and an overall survival of 11.1 weeks (JCO Precision Oncology, Aug 14, 2019; NCT02693535).||detail...|
|CDKN2A mutant||pancreatic cancer||not applicable||N/A||Guideline||Risk Factor||Germline mutations in CDKN2A results in familial malignant melanoma syndrome, which is associated with increased risk of developing pancreatic cancer (NCCN.org).||detail...|
|CDKN2A mutant||lung non-small cell carcinoma||sensitive||Palbociclib||Phase II||Actionable||In a Phase II trial (TAPUR), Ibrance (palbociclib) treatment resulted in a disease control rate of 29% (7/28, 1 partial response, 6 stable disease at 16 weeks) in patients with non-small cell lung cancer harboring CDKN2A loss or mutations, with a median progression-free survival of 9.7 weeks and a median overall survival of 20.6 months (J Clin Oncol 37, 2019 (suppl; abstr 9041); NCT02693535).||detail...|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT02478320||Phase II||ABT-348||Phase II Study of Ilorasertib (ABT348) in Patients With CDKN2A Deficient Solid Tumors||Active, not recruiting|
|NCT02187783||Phase II||Ribociclib||LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)||Completed|
|NCT03994796||Phase II||Abemaciclib GDC-0084 Entrectinib||Genetic Testing in Guiding Treatment for Patients With Brain Metastases||Recruiting|
|NCT01744652||Phase I||Crizotinib + Dasatinib||Dasatinib and Crizotinib in Advanced Cancer||Completed|
|NCT02576444||Phase II||Adavosertib + Olaparib Olaparib Capivasertib + Olaparib AZD6738 + Olaparib||OLAParib COmbinations (OLAPCO)||Active, not recruiting|
|NCT02540876||Phase I||ABT-348||Ilorasertib in Treating Patients With CDKN2A-deficient Advanced or Metastatic Solid Cancers That Cannot Be Removed by Surgery||Completed|
|NCT02693535||Phase II||Cobimetinib + Vemurafenib Regorafenib Ipilimumab + Nivolumab Palbociclib Afatinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Crizotinib Abemaciclib Sunitinib Olaparib||TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer||Recruiting|
|NCT03297606||Phase II||Bosutinib Palbociclib Vismodegib Ipilimumab + Nivolumab Cobimetinib + Vemurafenib Temsirolimus Olaparib Erlotinib Crizotinib Sunitinib Afatinib Dasatinib Pertuzumab + Trastuzumab Axitinib||Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (CAPTUR)||Recruiting|