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Gene | PIK3CA |
Variant | mutant |
Impact List | unknown |
Protein Effect | unknown |
Gene Variant Descriptions | PIK3CA mutant indicates an unspecified mutation within the PIK3CA gene. |
Associated Drug Resistance | |
Category Variants Paths |
PIK3CA mutant |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT01396408 | Phase II | Temsirolimus Sunitinib | A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours | Active, not recruiting | CAN | 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 |
NCT02465060 | Phase II | Erdafitinib Trametinib Crizotinib Sapanisertib Fexagratinib 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) | Active, not recruiting | USA | 2 |
NCT03006172 | Phase I | Inavolisib + Letrozole + Palbociclib Inavolisib Fulvestrant + Inavolisib Inavolisib + 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 | Active, not recruiting | USA | GBR | FRA | CAN | 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 | Active, not recruiting | 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) | Active, not recruiting | USA | CAN | AUS | 1 |
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 |
NCT04191499 | Phase II | Fulvestrant + Palbociclib Fulvestrant + Inavolisib + 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 (INAVO120) | Active, not recruiting | USA | TUR | POL | NZL | ITA | HUN | GRC | GBR | FRA | ESP | DNK | DEU | CAN | BRA | BEL | AUS | ARG | 11 |
NCT04192981 | Phase I | GDC-0084 | GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases | Active, not 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 (EPIK-B2) | Active, not recruiting | USA | ITA | FRA | ESP | BEL | 2 |
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 |
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) | Active, not recruiting | 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) | Active, not recruiting | SVK | ROU | POL | ITA | IRL | HUN | GRC | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BGR | BEL | 1 |
NCT05063786 | Phase III | Alpelisib + Fulvestrant + Trastuzumab Trastuzumab + Vinorelbine Alpelisib + Trastuzumab Capecitabine + Trastuzumab Eribulin + Trastuzumab | Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET) (ALPHABET) | Active, not recruiting | NLD | ITA | FRA | ESP | CHE | AUT | 0 |
NCT05646862 | Phase III | Alpelisib + Fulvestrant Fulvestrant + Inavolisib | A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy (INAVO121) | Active, not recruiting | USA | TUR | POL | ITA | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS | ARG | 6 |
NCT05708235 | Phase II | Giredestrant + Inavolisib Abemaciclib + Giredestrant Giredestrant | A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population (MiRaDoR) | Active, not recruiting | GBR | ESP | 0 |
NCT00770263 | Phase I | Erlotinib + Temsirolimus | Erlotinib and Temsirolimus for Solid Tumors | Completed | USA | 0 |
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 | NLD | GBR | ESP | DEU | 0 |
NCT01226316 | Phase I | Capivasertib | Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules | Completed | USA | NLD | ITA | GBR | FRA | ESP | DNK | CAN | 2 |
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 |
NCT01437566 | Phase II | Apitolisib 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 | NZL | ITA | ISR | GBR | FRA | ESP | DNK | DEU | CAN | BEL | AUS | ARG | 10 |
NCT01470209 | Phase I | Buparlisib + Everolimus | A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies | Completed | USA | 0 |
NCT01928459 | Phase I | Alpelisib + Infigratinib | Phase 1b Trial of BGJ398/BYL719 in Solid Tumors | Completed | USA | NLD | ITA | FRA | ESP | DEU | CHE | CAN | BEL | AUS | 2 |
NCT01971515 | Phase I | M2698 | First-in-Human Dose Escalation Trial in Subjects With Advanced Malignancies | Completed | 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 |
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 |
NCT02646319 | Phase I | Nab-rapamycin | Nanoparticle Albumin-Bound Rapamycin in Treating Patients With Advanced Cancer With mTOR Mutations | Completed | USA | 0 |
NCT02728258 | Phase II | Copanlisib | Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer | Completed | USA | 0 |
NCT02861300 | Phase Ib/II | Capecitabine + Telaglenastat | CB-839 + Capecitabine in Solid Tumors and Fluoropyrimidine Resistant PIK3CA Mutant Colorectal Cancer | 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 Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments (BYLieve) | Completed | USA | NLD | ITA | ISR | GBR | FRA | ESP | DNK | DEU | CAN | BEL | ARG | 7 |
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 |
NCT03767335 | Phase I | Fulvestrant + MEN1611 + Trastuzumab MEN1611 + Trastuzumab | MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer (B-PRECISE-01) | Completed | USA | ITA | GBR | FRA | ESP | BEL | 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 |
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) | Completed | ESP | 0 |
NCT04495621 | Phase Ib/II | Cetuximab + MEN1611 | MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01) (C-PRECISE-01) | Completed | USA | POL | NLD | ITA | FRA | ESP | DEU | 0 |
NCT04774952 | Phase I | RMC-5552 | Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors | 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 |
NCT06680596 | Phase II | Trastuzumab deruxtecan | Detecting Tumor DNA in the Blood of HR+/HER2-low Metastatic Breast Cancer Patients to Find Candidates for T-DXd Therapy (SAFIR3LibHERty) | Not yet recruiting | FRA | 0 |
NCT02523014 | Phase II | Abemaciclib GSK2256098 Vismodegib Capivasertib | Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients with Progressive Meningiomas | 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 |
NCT04253561 | Phase I | Ipatasertib + Pertuzumab + Trastuzumab | Ipatasertib + Pertuzumab +Trastuzumab in Advanced HER2+ PI3KCA-mutant Breast Cancer Patients (IPATHER) | Recruiting | ESP | 0 |
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 |
NCT05304962 | Phase I | RGT-419B | FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer | Recruiting | USA | 0 |
NCT05563220 | Phase Ib/II | Alpelisib + Elacestrant Elacestrant + Ribociclib Elacestrant + Everolimus Elacestrant + Palbociclib Abemaciclib + Elacestrant | Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer (ELEVATE) | Recruiting | USA | TUR | POL | LUX | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | BRA | BEL | AUS | ARG | 1 |
NCT05683418 | Phase I | TOS-358 | A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With Select Solid Tumors | Recruiting | USA | ESP | 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 |
NCT05773326 | Phase I | Temsirolimus | Superselective Intra-arterial Cerebral Infusion of Temsirolimus in HGG | Recruiting | USA | 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 |
NCT05894239 | Phase III | Inavolisib + Pertuzumab/trastuzumab/hyaluronidase-zzxf Pertuzumab/trastuzumab/hyaluronidase-zzxf | A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer (INAVO122) | Recruiting | USA | TUR | POL | ITA | GBR | FRA | FIN | ESP | DEU | CAN | BRA | BEL | AUS | ARG | 14 |
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 |
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 |
NCT06463028 | Phase II | Paclitaxel + Sapanisertib + Serabelisib | Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With Diet in Patients With Advanced/Recurrent Endometrial Cancer | Recruiting | USA | 0 |
NCT06496568 | Phase I | Atezolizumab + Inavolisib Inavolisib | A Study Evaluating Single-agent Inavolisib and Inavolisib Plus Atezolizumab in PIK3CA-Mutated Cancers | Recruiting | USA | CAN | 1 |
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 |
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 |
NCT02189174 | Phase Ib/II | CLR457 | Study of CLR457 Administered Orally in Adult Patients With Advanced Solid Malignancies | Terminated | USA | ESP | CAN | 2 |
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) | Terminated | USA | TUR | SWE | ROU | POL | NLD | ITA | GRC | FRA | FIN | ESP | DEU | CZE | CAN | BGR | AUT | AUS | 11 |
NCT02576444 | Phase II | Adavosertib + Olaparib Olaparib Capivasertib + Olaparib Ceralasertib + Olaparib | OLAParib COmbinations (OLAPCO) | 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 |
NCT02961283 | Phase I | ASN003 | Study of ASN003 in Subjects With Advanced Solid Tumors | Terminated | USA | 0 |
NCT02987959 | Phase II | Sapanisertib | Study of TAK-228 (MLN0128) in Soft Tissue Sarcomas | Terminated | 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) | Terminated | USA | 1 |
NCT04916236 | Phase I | LY3214996 + RMC-4630 | Combination Therapy of RMC-4630 and LY3214996 in Metastatic KRAS Mutant Cancers (SHERPA) | Terminated | NLD | 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 | Withdrawn | USA | 0 |
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