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Gene Symbol | PTEN | ||||||||||
Synonyms | 10q23del | BZS | CWS1 | DEC | GLM2 | MHAM | MMAC1 | PTEN1 | PTENbeta | PTENgama | TEP1 | ||||||||||
Gene Description | PTEN, phosphatidylinositol 3,4,5-trisphosphate 3-phosphatase and dual-specificity protein phosphatase PTEN, is a tumor suppressor (PMID: 30562755) with roles in the cell cycle, growth, DNA repair, cell survival and regulation of the Akt-mTOR pathway (PMID: 24656806, PMID: 30145641). PTEN germline mutations are common in Cowden syndrome (PMID: 30562755) and PTEN somatic alterations resulting in loss of function have been found in many types of cancer including, but not limited to endometrial (PMID: 30142194), melanoma (PMID: 30148988), and prostate (PMID: 18767981, PMID: 30153654). | ||||||||||
ACMG Incidental List v3.0: |
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Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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NCT01870726 | Phase Ib/II | Buparlisib + Capmatinib | Safety and Efficacy of INC280 and Buparlisib (BKM120) in Patients With Recurrent Gliobastoma | Terminated | USA | NLD | ESP | DEU | CHE | 0 |
NCT06239467 | Phase I | OKI-219 + Trastuzumab OKI-219 Fulvestrant + OKI-219 | First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer (PIKture-01) | Recruiting | USA | FRA | ESP | BEL | 1 |
NCT04493853 | Phase III | Abiraterone + Capivasertib Abiraterone | Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency (CAPItello-281) | Active, not recruiting | USA | TUR | SVK | POL | NLD | ISR | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BGR | BEL | AUT | AUS | ARG | 14 |
NCT04592237 | Phase II | Niraparib Cabazitaxel + Carboplatin + Cetrelimab Cetrelimab + Niraparib | Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer | Active, not recruiting | USA | 0 |
NCT05038839 | Phase I | Cabozantinib + Pamiparib | Cabozantinib and Pamiparib for the Treatment of Advanced of Refractory Solid Tumors | Active, not recruiting | USA | 0 |
NCT04317105 | Phase Ib/II | Copanlisib + Ipilimumab + Nivolumab Copanlisib + Nivolumab | Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Immunotherapy (Nivolumab With or Without Ipilimumab) in Patients With Advanced Solid Cancers That Have Changes in the Following Genes: PIK3CA and PTEN | Active, not recruiting | USA | CAN | 0 |
NCT05843253 | Phase II | Everolimus + Ribociclib | Study of Ribociclib and Everolimus in HGG and DIPG | Recruiting | USA | NLD | GBR | DEU | CAN | AUS | 0 |
NCT02920450 | Phase Ib/II | Carboplatin + Gedatolisib + Paclitaxel | Study of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002) | Terminated | USA | 0 |
NCT02761694 | Phase I | ARQ 751 + Paclitaxel ARQ 751 ARQ 751 + Fulvestrant | ARQ 751 as a Single Agent or in Combination With Other Anti-Cancer Agents, in Solid Tumors With PIK3CA / AKT / PTEN Mutations | Terminated | USA | 0 |
NCT03317119 | Phase I | Trametinib + Trifluridine-tipiracil hydrochloride | Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery | Completed | USA | 0 |
NCT04632992 | Phase II | Ipatasertib Atezolizumab + Capecitabine Entrectinib Atezolizumab + Docetaxel Ado-trastuzumab emtansine + Atezolizumab Capecitabine + Pertuzumab/trastuzumab/hyaluronidase-zzxf Paclitaxel + Pertuzumab/trastuzumab/hyaluronidase-zzxf Alectinib Inavolisib Pertuzumab/trastuzumab/hyaluronidase-zzxf Docetaxel + Pertuzumab/trastuzumab/hyaluronidase-zzxf Atezolizumab + Paclitaxel Ado-trastuzumab emtansine + Tucatinib | A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response (MyTACTIC) | Completed | USA | 0 |
NCT01884285 | Phase I | AZD8186 Abiraterone + AZD8186 AZD8186 + Vistusertib | AZD8186 First Time In Patient Ascending Dose Study | Completed | USA | GBR | ESP | CAN | 0 |
NCT02189174 | Phase Ib/II | CLR457 | Study of CLR457 Administered Orally in Adult Patients With Advanced Solid Malignancies | Terminated | USA | ESP | CAN | 2 |
NCT01097278 | Phase 0 | Cholecalciferol | S0812 High Dose Cholecalciferol in Premenopausal Women at High-Risk for Breast Cancer | Completed | USA | 0 |
NCT03218826 | Phase I | AZD8186 + Docetaxel | PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery | Active, not recruiting | USA | 0 |
NCT03209401 | Phase I | Carboplatin + Niraparib | Niraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies | Terminated | USA | 0 |
NCT04216472 | Phase II | Alpelisib + Nab-paclitaxel | Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations | Active, not recruiting | USA | 0 |
NCT04108858 | Phase Ib/II | Copanlisib + Pertuzumab + Trastuzumab Pertuzumab + Trastuzumab | Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer | Terminated | USA | 0 |
NCT05379972 | Phase II | Olaparib + Pembrolizumab | Study of SBRT/Olaparib Followed by Pembrolizumab/Olaparib in Gastric Cancers | Recruiting | USA | 0 |
NCT03842228 | Phase I | Copanlisib + Durvalumab + Olaparib | Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations | Active, not recruiting | USA | 0 |
NCT05082025 | Phase II | Copanlisib + Fulvestrant | Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations | Active, not recruiting | USA | 0 |
NCT04770246 | Phase II | TAS-117 | TAS-117 in Patients With Advanced Solid Tumors Harboring Germline PTEN Mutations | Terminated | USA | GBR | FRA | AUT | 0 |
NCT05010096 | Phase I | Copanlisib + Elimusertib | BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors | Withdrawn | 0 | |
NCT02401347 | Phase II | Talazoparib | Phase II Trial of Talazoparib in BRCA1/2 Wild-type HER2-negative Breast Cancer and Other Solid Tumors | Completed | USA | 0 |
NCT06029998 | Phase II | Bortezomib | Bortezomib in Patients With Metastatic Castration-Resistant Prostate Cancer With PTEN Deletion (BORXPTEN) | Recruiting | USA | 0 |
NCT06287463 | Phase Ib/II | DCC-3084 | Study of DCC-3084 in Participants With Advanced Malignancies Driven by the Mitogen-Activated Protein Kinase (MAPK) Pathway | Recruiting | USA | 0 |
NCT03207529 | Phase I | Alpelisib + Enzalutamide | Alpelisib and Enzalutamide in Treating Patients With Androgen Receptor and PTEN Positive Metastatic Breast Cancer | Completed | USA | 0 |
NCT03065062 | Phase I | Gedatolisib + Palbociclib | Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell Lung, Pancreatic, Head & Neck and Other Solid Tumors | Recruiting | USA | 0 |
NCT05691465 | Phase II | lutetium Lu 177 dotatate | Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells | Recruiting | USA | 0 |
NCT00770263 | Phase I | Erlotinib + Temsirolimus | Erlotinib and Temsirolimus for Solid Tumors | Completed | USA | 0 |
NCT04737109 | Phase Ib/II | Darolutamide + Ipatasertib | Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men With Localized, High Risk Prostate Cancer | Terminated | USA | 0 |
NCT05773326 | Phase I | Temsirolimus | Superselective Intra-arterial Cerebral Infusion of Temsirolimus in HGG | Recruiting | USA | 0 |
NCT03131908 | Phase Ib/II | GSK2636771 + Pembrolizumab | Study of the Selective PI3K-Beta Inhibitor GSK2636771 in Combination With Pembrolizumab in Patients With Metastatic Melanoma and PTEN Loss | Active, not recruiting | USA | 0 |
NCT01458067 | Phase I | GSK2636771 | A Phase I/IIa, First Time in Human, Study of GSK2636771 in Subjects With Advanced Solid Tumors With Phosphatase and Tensin Homolog (PTEN) Deficiency | Completed | USA | GBR | 1 |
NCT02576444 | Phase II | Adavosertib + Olaparib Olaparib Capivasertib + Olaparib Ceralasertib + Olaparib | OLAParib COmbinations (OLAPCO) | Terminated | USA | 0 |
NCT03673787 | Phase Ib/II | Atezolizumab + Ipatasertib | A Trial of Ipatasertib in Combination With Atezolizumab (IceCAP) | Unknown status | GBR | 0 |
NCT05810870 | Phase II | Eribulin + MEN1611 MEN1611 | PIK3CA/PTEN-altered Advanced Breast Cancer Treated With MEN1611 Monotherapy or in Combination With Eribulin (SABINA) | Recruiting | ESP | 0 |
NCT04586270 | Phase I | TAS0612 | A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer | Recruiting | USA | FRA | 0 |
NCT02987959 | Phase II | Sapanisertib | Study of TAK-228 (MLN0128) in Soft Tissue Sarcomas | Terminated | USA | 0 |
NCT03834740 | Phase I | Everolimus + Ribociclib | A Phase 0 /II Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection | Completed | USA | 0 |
NCT06218667 | Phase Ib/II | Copanlisib + Degarelix | A Study of Copanlisib in Combination With Degarelix in People With Prostate Cancer | Withdrawn | 0 | |
NCT04251533 | Phase III | Alpelisib + Nab-paclitaxel Nab-paclitaxel | Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss (EPIK-B3) | Active, not recruiting | USA | TUR | SVN | SVK | POL | NOR | ITA | ISR | HUN | HRV | GBR | FRA | ESP | DEU | CHE | BRA | BGR | AUT | AUS | ARG | 10 |
NCT02215096 | Phase I | Enzalutamide GSK2636771 | Dose-finding Study of GSK2636771 When Administered in Combination With Enzalutamide in Male Subjects With Metastatic Castration-Resistant Prostate Cancer | Completed | USA | GBR | 0 |
NCT03624543 | Phase II | CFI-400945 | CFI-400945 in Patients With Advanced/Metastatic Breast Cancer | Active, not recruiting | CAN | 0 |
NCT04388852 | Phase I | DS-3201b + Ipilimumab | DS3201 and Ipilimumab for the Treatment of Metastatic Prostate, Urothelial and Renal Cell Cancers | Recruiting | USA | 0 |
NCT04551521 | Phase II | Atezolizumab Atezolizumab + Ipatasertib Atezolizumab + Pertuzumab + Trastuzumab Atezolizumab + Cobimetinib Alectinib Atezolizumab + Cobimetinib + Vemurafenib | CRAFT: The NCT-PMO-1602 Phase II Trial | Recruiting | DEU | 0 |
NCT02961283 | Phase I | ASN003 | Study of ASN003 in Subjects With Advanced Solid Tumors | Terminated | USA | 0 |
NCT02549989 | Phase II | LY3023414 | Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer | Completed | USA | 0 |
NCT05300048 | Phase I | Serabelisib Nab-paclitaxel + Serabelisib | Combination of Serabelisib and Insulin Suppressing Diet With or Without Nab-paclitaxel in Subjects With Advanced Solid Tumors With PIK3CA Mutations | Active, not recruiting | USA | 0 |
NCT02523014 | Phase II | Abemaciclib GSK2256098 Vismodegib Capivasertib | Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas | Recruiting | USA | 0 |
NCT01396408 | Phase II | Temsirolimus Sunitinib | A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours | Active, not recruiting | CAN | 0 |
NCT04042831 | Phase II | Olaparib | Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations | Recruiting | USA | 0 |
NCT05933395 | Phase II | Abemaciclib + Fulvestrant Fulvestrant + Neratinib Alpelisib + Fulvestrant Everolimus + Fulvestrant | Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor (GERTRUDE) | Recruiting | USA | 0 |
NCT01306045 | Phase II | Erlotinib Lapatinib MK2206 Sunitinib Selumetinib | Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies | Completed | USA | 0 |
NCT01971515 | Phase I | M2698 | First-in-Human Dose Escalation Trial in Subjects With Advanced Malignancies | Completed | USA | 0 |
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 | CAN | 0 |
NCT02644122 | Phase II | SF1126 | SF1126 in Recurrent or Progressive SCCHN and Mutations in PIK3CA Gene and/or PI-3 Kinase Pathway Genes | Terminated | USA | 0 |
NCT02315625 | Phase II | Everolimus Sunitinib | Study of Mutation-Targeted Therapy With Sunitinib or Everolimus in People With Advanced Low- or Intermediate-Grade Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas With or Without Cytoreductive Surgery | Terminated | USA | 0 |
NCT01470209 | Phase I | Buparlisib + Everolimus | A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies | Completed | USA | 0 |
NCT04958226 | Phase I | Capivasertib + Midazolam | A Study to Assess the Effect of Capivasertib on Midazolam in Patients With Advanced Solid Tumours | Completed | USA | 0 |
NCT05768139 | Phase Ib/II | Fulvestrant + STX-478 STX-478 | First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors | Recruiting | USA | ITA | FRA | ESP | 0 |
NCT03337724 | Phase II | Ipatasertib + Paclitaxel Paclitaxel | A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer (IPATunity130) | Completed | USA | TUR | SVN | POL | ITA | HUN | GRC | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUS | ARG | 13 |
NCT04774952 | Phase I | RMC-5552 | Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors | Active, not recruiting | USA | 0 |
NCT01226316 | Phase I | Capivasertib | Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules | Active, not recruiting | USA | NLD | ITA | GBR | FRA | ESP | DNK | CAN | 2 |
NCT03207347 | Phase II | Niraparib | A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001) | Completed | USA | 0 |
NCT03088059 | Phase II | Niraparib Durvalumab + Monalizumab Methotrexate Carboplatin Rogaratinib Mitomycin C Docetaxel Afatinib Paclitaxel Durvalumab Monalizumab Palbociclib Bleomycin Gemcitabine Fluorouracil | Biomarker-based Study in R/M SCCHN (UPSTREAM) | Active, not recruiting | ITA | GBR | FRA | ESP | BEL | 0 |
NCT03360721 | Phase II | Abiraterone + Apalutamide + Prednisone | Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer | Active, not recruiting | USA | 0 |