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Profile Name | PIK3CA I910V |
Gene Variant Detail | |
Relevant Treatment Approaches | Akt Inhibitor (Pan) Akt1 Inhibitor Akt2 Inhibitor mTOR Inhibitor mTORC1 Inhibitor mTORC2 Inhibitor PI3K Inhibitor (Pan) PIK3CA inhibitor |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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NCT05154487 | Phase II | Alpelisib + Fulvestrant | A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer | Not yet recruiting | USA | 0 |
NCT05216432 | Phase I | RLY-2608 Fulvestrant + RLY-2608 | First-in-Human Study of Mutant-selective PI3Ka Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients With Advanced Breast Cancer | Recruiting | USA | 0 |
NCT02987959 | Phase II | Sapanisertib | Study of TAK-228 (MLN0128) in Soft Tissue Sarcomas | Terminated | USA | 0 |
NCT02961283 | Phase I | ASN003 | Study of ASN003 in Subjects With Advanced Solid Tumors | Terminated | USA | 0 |
NCT04191499 | Phase II | Fulvestrant + Palbociclib Fulvestrant + GDC-0077 + Palbociclib | A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 17 |
NCT01776008 | Phase II | Goserelin + MK2206 | Akt Inhibitor MK-2206 and Anastrozole With or Without Goserelin Acetate in Treating Patients With Stage II-III Breast Cancer | Terminated | USA | 0 |
NCT04958226 | Phase I | Capivasertib + Midazolam | A Study to Assess the Effect of Capivasertib on Midazolam in Patients With Advanced Solid Tumours | Recruiting | USA | 0 |
NCT00770263 | Phase I | Erlotinib + Temsirolimus | Erlotinib and Temsirolimus for Solid Tumors | Completed | USA | 0 |
NCT02728258 | Phase II | Copanlisib | Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer | Completed | USA | 0 |
NCT03006172 | Phase I | GDC-0077 + Letrozole + Palbociclib GDC-0077 Fulvestrant + GDC-0077 GDC-0077 + Letrozole | To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer | Recruiting | USA | FRA | ESP | CAN | 1 |
NCT01791478 | Phase I | Alpelisib + Letrozole | BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer | Active, not recruiting | USA | 0 |
NCT01928459 | Phase I | Alpelisib + Infigratinib | Phase 1b Trial of BGJ398/BYL719 in Solid Tumors | Completed | USA | ITA | FRA | ESP | DEU | CAN | BEL | 5 |
NCT05038735 | Phase III | Alpelisib + Fulvestrant Fulvestrant | Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-postitive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. (EPIK-B5) | Recruiting | ITA | FRA | ESP | DEU | BEL | 8 |
NCT01470209 | Phase I | Buparlisib + Everolimus | A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies | Completed | USA | 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 | Recruiting | USA | ITA | FRA | ESP | DEU | AUT | 27 |
NCT01226316 | Phase I | Capivasertib | Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules | Active, not recruiting | USA | ITA | FRA | ESP | CAN | 5 |
NCT02124148 | Phase I | Cisplatin + Prexasertib Cetuximab + Prexasertib Pemetrexed Disodium + Prexasertib LY3023414 + Prexasertib Fluorouracil + Leucovorin + Prexasertib | A Study of Prexasertib (LY2606368) With Chemotherapy or Targeted Agents in Participants With Advanced Cancer | Completed | USA | 0 |
NCT04997902 | Phase Ib/II | Alpelisib + Tipifarnib | Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) | Recruiting | 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 |
NCT01396408 | Phase II | Temsirolimus Sunitinib | A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours | Active, not recruiting | CAN | 0 |
NCT02861300 | Phase Ib/II | Capecitabine + Telaglenastat | CB-839 + Capecitabine in Solid Tumors and Fluoropyrimidine Resistant PIK3CA Mutant Colorectal Cancer | Active, not recruiting | USA | 0 |
NCT04774952 | Phase I | RMC-5552 | Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors | Recruiting | USA | 0 |
NCT02646319 | Phase I | Nab-rapamycin | Nanoparticle Albumin-Bound Rapamycin in Treating Patients With Advanced Cancer With mTOR Mutations | Completed | 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 | Recruiting | 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 |
NCT04899349 | Phase II | Alpelisib + Fulvestrant + Metformin Alpelisib + Dapagliflozin + Fulvestrant + Metformin | Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant (EPIK-B4) | Recruiting | USA | 1 |
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 | Active, not recruiting | USA | 0 |
NCT01971515 | Phase I | M2698 | First-in-Human Dose Escalation Trial in Subjects With Advanced Malignancies | Completed | USA | 0 |
NCT03056755 | Phase II | Alpelisib + Fulvestrant Alpelisib + Letrozole | Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutation With Advanced Breast Cancer Who Have Progressed on or After Prior Treatments (BYLieve) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 12 |
NCT04300790 | Phase II | Alpelisib + Fulvestrant + Metformin | Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients (METALLICA) | Recruiting | ESP | 0 |
NCT02167854 | Phase I | Alpelisib + Elgemtumab + Trastuzumab | Open-Label Study Evaluating the Safety and Tolerability of LJM716, BYL719 and Trastuzumab in Patients With Metastatic HER2+ Breast Cancer | Completed | 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 |
NCT03032406 | Phase II | Everolimus + Hydroxychloroquine Everolimus Hydroxychloroquine | CLEVER Pilot Trial: A Phase II Pilot Trial of HydroxyChLoroquine, EVErolimus or the Combination for Prevention of Recurrent Breast Cancer | Recruiting | USA | 0 |
NCT01437566 | Phase II | GDC-0980 Fulvestrant Pictilisib | Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Patients Resistant to Aromatase Inhibitor Therapy | Completed | USA | ITA | FRA | ESP | DEU | CAN | BEL | 16 |
NCT04192981 | Phase I | GDC-0084 | GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases | Recruiting | USA | 0 |
NCT04208178 | Phase III | Pertuzumab + Trastuzumab Alpelisib + Pertuzumab + Trastuzumab | Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation | Recruiting | USA | FRA | ESP | BEL | 1 |
NCT03767335 | Phase I | CH5132799 + Fulvestrant + Trastuzumab CH5132799 + Trastuzumab | MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer (B-PRECISE-01) | Active, not recruiting | USA | ITA | FRA | ESP | BEL | 1 |
NCT04762979 | Phase II | Alpelisib + Fulvestrant | Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer | Recruiting | USA | 0 |
NCT01708161 | Phase I | Alpelisib + Ganitumab | A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors | Terminated | USA | ESP | CAN | BEL | 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) | Recruiting | CAN | 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 | Active, not recruiting | USA | 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) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 23 |
NCT02465060 | Phase II | Erdafitinib Trametinib Crizotinib Sapanisertib AZD4547 Dasatinib Osimertinib Palbociclib Capivasertib Larotrectinib Ulixertinib Nivolumab + Relatlimab Copanlisib Sunitinib Nivolumab Pertuzumab + Trastuzumab Ipatasertib Dabrafenib + Trametinib Binimetinib Adavosertib Afatinib Defactinib GSK2636771 Vismodegib Ado-trastuzumab emtansine Taselisib | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) | Recruiting | USA | 2 |
NCT02576444 | Phase II | Adavosertib + Olaparib Olaparib Capivasertib + Olaparib Ceralasertib + Olaparib | OLAParib COmbinations (OLAPCO) | Active, not recruiting | USA | 0 |
NCT02189174 | Phase Ib/II | CLR457 | Study of CLR457 Administered Orally in Adult Patients With Advanced Solid Malignancies | Terminated | USA | ESP | CAN | 2 |
NCT01219699 | Phase I | Alpelisib Alpelisib + Fulvestrant | A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene | Completed | USA | ESP | DEU | 2 |
NCT05063786 | Phase III | Alpelisib + Fulvestrant + Trastuzumab Trastuzumab + Vinorelbine Alpelisib + Trastuzumab Capecitabine + Trastuzumab Eribulin + Trastuzumab | Trial of Trastuzumab + ALpelisib +/- Fulvestrant vs Trastuzumab + Chemotherapy in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET) | Recruiting | ESP | 0 |
NCT04589845 | Phase II | Alectinib Ado-trastuzumab emtansine Ipatasertib GDC-0077 Entrectinib Atezolizumab Idasanutlin | Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 16 |
NCT04495621 | Phase Ib/II | Cetuximab + CH5132799 | MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01) | Recruiting | USA | ITA | FRA | ESP | DEU | 2 |
NCT04253561 | Phase I | Ipatasertib + Pertuzumab + Trastuzumab | Ipatasertib + Pertuzumab +Trastuzumab in Advanced HER2+ PI3KCA-mutant Breast Cancer Patients (IPATHER) | Recruiting | ESP | 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 |
NCT02340221 | Phase III | Fulvestrant + Taselisib Fulvestrant | A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy (SANDPIPER) | Completed | USA | ITA | FRA | ESP | DEU | CAN | AUT | 21 |
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 |
NCT04586335 | Phase I | CYH33 + Olaparib | Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. | Recruiting | USA | 1 |
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 | Recruiting | USA | 0 |
NCT05090358 | Phase II | Alpelisib + Fulvestrant Alpelisib + Canagliflozin + Fulvestrant | Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer | Recruiting | USA | 0 |
NCT05300048 | Phase I | Serabelisib | Combination of Serabelisib and Insulin Suppressing Diet in Subjects With Advanced Solid Tumors With PIK3CA Mutations | 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 | Not yet recruiting | USA | 0 |
NCT04053322 | Phase II | Durvalumab + Fulvestrant + Olaparib | Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients. (DOLAF) | Recruiting | FRA | 0 |
NCT03213678 | Phase II | LY3023414 | Samotolisib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations (A Pediatric MATCH Treatment Trial) | Recruiting | USA | 1 |
NCT03673787 | Phase Ib/II | Atezolizumab + Ipatasertib | A Trial of Ipatasertib in Combination With Atezolizumab (IceCAP) | Recruiting | 1 | |
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 | Active, not recruiting | USA | 0 |
NCT01833169 | Phase II | Buparlisib | BKM120 for Patients With PI3K-activated Tumors | 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 GDC-0077 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) | 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 | Recruiting | USA | CAN | 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 |
NCT03941782 | Phase 0 | Alpelisib | Compassionate Use of BYL 719 Alpelisib | Available | USA | 0 |
NCT05332561 | Phase II | Olaparib Ipatasertib Sacituzumab govitecan-hziy GDC-0077 Pertuzumab/trastuzumab/hyaluronidase-zzxf Atezolizumab | Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE) | Not yet recruiting | DEU | 0 |
NCT03155620 | Phase II | Tazemetostat Larotrectinib LY3023414 Vemurafenib Palbociclib Olaparib Ulixertinib Erdafitinib Selumetinib Ensartinib | Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) | Recruiting | USA | 1 |
NCT05230810 | Phase Ib/II | Alpelisib + Fulvestrant + Tucatinib | Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer. | Not yet recruiting | USA | 0 |
NCT02549989 | Phase II | LY3023414 | Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer | Completed | USA | 0 |
NCT05010096 | Phase I | BAY1895344 + Copanlisib | BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors | Not yet recruiting | 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 | Unknown status | 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 |
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 |
NCT03457896 | Phase II | Cetuximab + Neratinib Neratinib + Trastuzumab | Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Colorectal Cancer by HER2 Status | Active, not recruiting | USA | 0 |
NCT01960023 | Phase Ib/II | Cetuximab + Neratinib | Safety and Efficacy Study of Neratinib and Cetuximab to Treat Patients With Quadruple Wild-Type Metastatic Colorectal Cancer | Withdrawn | USA | 0 |