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| Profile Name | PTEN inact mut |
| Gene Variant Detail | |
| Relevant Treatment Approaches | Akt Inhibitor (Pan) Akt1 Inhibitor Akt2 Inhibitor PI3K Inhibitor (Pan) PIK3CB inhibitor |
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 |
| NCT05379972 | Phase II | Olaparib + Pembrolizumab | Study of SBRT/Olaparib Followed by Pembrolizumab/Olaparib in Gastric Cancers | Active, not recruiting | 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 |
| 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 |
| 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 |
| NCT04486352 | Phase Ib/II | Atezolizumab + Talazoparib Atezolizumab + Ipatasertib Abemaciclib + Giredestrant Inavolisib + Letrozole | A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer (EndoMAP) | 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 |
| NCT06941480 | Phase I | 177Lu-DTPA-SC16 | A Study of 177Lu-DTPA-SC16.56 in People With Neuroendocrine Carcinomas of the Lung and Prostate | Not yet recruiting | USA | 0 |
| NCT05455619 | Phase Ib/II | Capivasertib + Fulvestrant + SDX-7320 Alpelisib + Fulvestrant + SDX-7320 | Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/ Her2- Breast Cancer (Amelia-1) | Recruiting | USA | 0 |
| NCT06764186 | Phase III | Capivasertib + Fulvestrant | A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain (CAPItana) | Recruiting | ESP | 0 |
| NCT05843253 | Phase II | Ribociclib + Temozolomide Everolimus + Ribociclib | Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant | Recruiting | USA | NLD | GBR | DEU | CAN | AUS | 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 |
| NCT05111561 | Phase I | Binimetinib + ZEN-3694 | Testing the Combination of the Anticancer Drugs ZEN003694 and Binimetinib in Patients With Advanced/Metastatic or Unresectable Solid Tumors With RAS Alterations and Triple Negative Breast Cancer | Suspended | 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 | Terminated | 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 |
| 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 |
| NCT04770246 | Phase II | TAS-117 | TAS-117 in Patients With Advanced Solid Tumors Harboring Germline PTEN Mutations | Terminated | USA | GBR | FRA | AUT | 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 |
| 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 |
| NCT06239467 | Phase I | OKI-219 + Trastuzumab + Tucatinib OKI-219 Fulvestrant + OKI-219 + PF-07220060 Fulvestrant + OKI-219 Fulvestrant + OKI-219 + Ribociclib | First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer (PIKture-01) | Recruiting | USA | ITA | FRA | ESP | BEL | 1 |
| NCT06085729 | Phase Ib/II | ADI-PEG 20 + Cabazitaxel + Carboplatin | Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC) | Recruiting | 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 |
| NCT03209401 | Phase I | Carboplatin + Niraparib | Niraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies | Terminated | USA | 0 |
| NCT05038839 | Phase I | Cabozantinib + Pamiparib | Cabozantinib and Pamiparib for the Treatment of Advanced of Refractory Solid Tumors | Active, not recruiting | USA | 0 |
| NCT05554380 | Phase II | Ipatasertib + Paclitaxel | Study of Chemotherapy Plus Ipatasertib for People With Solid Tumors With AKT Mutations, A ComboMATCH Treatment Trial | Recruiting | USA | 1 |
| NCT06982521 | Phase III | Fulvestrant + RLY-2608 Capivasertib + Fulvestrant | Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer (ReDiscover-2) | Recruiting | USA | 0 |
| NCT05010096 | Phase I | Copanlisib + Elimusertib | BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors | Withdrawn | 0 | |
| NCT05039801 | Phase I | Capivasertib + IACS-6274 Bevacizumab + IACS-6274 + Paclitaxel IACS-6274 | IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors | Recruiting | USA | 0 |
| NCT01097278 | Phase 0 | Cholecalciferol | S0812 High Dose Cholecalciferol in Premenopausal Women at High-Risk for Breast Cancer | Completed | USA | 0 |