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Profile Name | PIK3CA mutant |
Gene Variant Detail | |
Relevant Treatment Approaches |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
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 |
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 |
NCT02987959 | Phase II | Sapanisertib | Study of TAK-228 (MLN0128) in Soft Tissue Sarcomas | Terminated | USA | 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 |
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 |
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 |
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) | Active, not recruiting | USA | 2 |
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 |
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 | Active, not recruiting | USA | ITA | FRA | ESP | DEU | AUT | 26 |
NCT02728258 | Phase II | Copanlisib | Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer | Completed | USA | 0 |
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 | CAN | BEL | 10 |
NCT04495621 | Phase Ib/II | Cetuximab + CH5132799 | MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01) | Recruiting | USA | ITA | FRA | ESP | DEU | 2 |
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 |
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 |
NCT02861300 | Phase Ib/II | Capecitabine + Telaglenastat | CB-839 + Capecitabine in Solid Tumors and Fluoropyrimidine Resistant PIK3CA Mutant Colorectal Cancer | Active, not recruiting | USA | 0 |
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 |
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 |
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 |
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 |
NCT02523014 | Phase II | Abemaciclib GSK2256098 Vismodegib Capivasertib | Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas | 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 |
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 |
NCT02646319 | Phase I | Nab-rapamycin | Nanoparticle Albumin-Bound Rapamycin in Treating Patients With Advanced Cancer With mTOR Mutations | Completed | USA | 0 |
NCT04774952 | Phase I | RMC-5552 | Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors | Recruiting | 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 |
NCT00770263 | Phase I | Erlotinib + Temsirolimus | Erlotinib and Temsirolimus for Solid Tumors | Completed | USA | 0 |
NCT01470209 | Phase I | Buparlisib + Everolimus | A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies | Completed | USA | 0 |
NCT04253561 | Phase I | Ipatasertib + Pertuzumab + Trastuzumab | Ipatasertib + Pertuzumab +Trastuzumab in Advanced HER2+ PI3KCA-mutant Breast Cancer Patients (IPATHER) | Recruiting | ESP | 0 |
NCT02189174 | Phase Ib/II | CLR457 | Study of CLR457 Administered Orally in Adult Patients With Advanced Solid Malignancies | Terminated | USA | ESP | CAN | 2 |
NCT02576444 | Phase II | Adavosertib + Olaparib Olaparib Capivasertib + Olaparib Ceralasertib + Olaparib | OLAParib COmbinations (OLAPCO) | Terminated | USA | 0 |
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 |
NCT01791478 | Phase I | Alpelisib + Letrozole | BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer | Active, not recruiting | USA | 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 | 18 |
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 |
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 |
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 | Active, not recruiting | USA | ITA | FRA | ESP | CAN | BEL | 12 |
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 |
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 | ESP | 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 |
NCT02961283 | Phase I | ASN003 | Study of ASN003 in Subjects With Advanced Solid Tumors | Terminated | USA | 0 |
NCT01971515 | Phase I | M2698 | First-in-Human Dose Escalation Trial in Subjects With Advanced Malignancies | Completed | 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 |
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 |
NCT01928459 | Phase I | Alpelisib + Infigratinib | Phase 1b Trial of BGJ398/BYL719 in Solid Tumors | Completed | USA | ITA | FRA | ESP | DEU | CAN | BEL | 5 |
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) | Active, not recruiting | ESP | 0 |
NCT05356897 | Phase II | Trastuzumab + Trifluridine-tipiracil hydrochloride + Tucatinib | Tucatinib Combined With Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients, 3T Study | Not yet recruiting | USA | 0 |
NCT04958226 | Phase I | Capivasertib + Midazolam | A Study to Assess the Effect of Capivasertib on Midazolam in Patients With Advanced Solid Tumours | 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 | ITA | FRA | ESP | CAN | 5 |
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) | Terminated | USA | ITA | FRA | ESP | DEU | CAN | AUT | 21 |
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 | ITA | FRA | ESP | AUT | 2 |
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 |
NCT01396408 | Phase II | Temsirolimus Sunitinib | A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours | Active, not recruiting | CAN | 0 |