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Profile Name PIK3CA mutant
Gene Variant Detail

PIK3CA mutant (unknown)

Relevant Treatment Approaches

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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