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Profile Name PIK3CA act mut
Gene Variant Detail

PIK3CA act mut (gain of function)

Relevant Treatment Approaches Akt Inhibitor (Pan) Akt1 Inhibitor Akt2 Inhibitor mTOR Inhibitor mTORC1 Inhibitor mTORC2 Inhibitor PI3K Inhibitor (Pan) PIK3CA inhibitor

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03941782 Phase 0 Alpelisib Compassionate Use of BYL 719 Alpelisib No longer available USA 0
NCT05392608 Phase II Alpelisib + Fulvestrant SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast) (SEQUEL-Breast) Recruiting NLD 0
NCT05307705 Phase I Abemaciclib + Anastrozole + LOXO-783 Abemaciclib + Exemestane + LOXO-783 Abemaciclib + Letrozole + LOXO-783 LOXO-783 + Paclitaxel Fulvestrant + LOXO-783 LOXO-783 + LY3484356 Abemaciclib + Fulvestrant + LOXO-783 Abemaciclib + LOXO-783 + LY3484356 Letrozole + LOXO-783 LOXO-783 Anastrozole + LOXO-783 Exemestane + LOXO-783 A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors (PIKASSO-01) Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 4
NCT02549989 Phase II LY3023414 Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer Completed USA 0
NCT05010096 Phase I Copanlisib + Elimusertib BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors Withdrawn 0
NCT05090358 Phase II Alpelisib + Fulvestrant Alpelisib + Canagliflozin + Fulvestrant Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer Active, not recruiting USA 0
NCT01833169 Phase II Buparlisib BKM120 for Patients With PI3K-activated Tumors Completed USA 0
NCT05759949 Phase I Fulvestrant + RLY-5836 RLY-5836 Fulvestrant + Palbociclib + RLY-5836 Abemaciclib + Fulvestrant + RLY-5836 Fulvestrant + Ribociclib + RLY-5836 First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors Active, not recruiting USA 0
NCT05216432 Phase I RLY-2608 Fulvestrant + RLY-2608 First-in-Human Study of Mutant-selective PI3Kalpha 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 | ITA | FRA | ESP 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
NCT03673787 Phase Ib/II Atezolizumab + Ipatasertib A Trial of Ipatasertib in Combination With Atezolizumab (IceCAP) Unknown status GBR 0
NCT02925234 Phase II Palbociclib Ribociclib Lenvatinib Ipilimumab + Nivolumab Trametinib Crizotinib Niraparib Selpercatinib Olaparib Erlotinib Erdafitinib Dabrafenib Dacomitinib Rucaparib Axitinib Panitumumab Pemigatinib Durvalumab Afatinib Entrectinib Tepotinib Alpelisib Atezolizumab + Bevacizumab Alectinib Regorafenib Cobimetinib + Vemurafenib Nilotinib Vismodegib Abemaciclib Sunitinib Nivolumab Cabozantinib Lorlatinib Talazoparib Dabrafenib + Trametinib Pembrolizumab Pertuzumab + Trastuzumab The Drug Rediscovery Protocol (DRUP Trial) (DRUP) Recruiting NLD 0
NCT05230810 Phase Ib/II Alpelisib + Fulvestrant + Tucatinib Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer. Recruiting USA 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) Active, not recruiting USA 1
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
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
NCT05332561 Phase II Olaparib Ipatasertib Sacituzumab govitecan-hziy Inavolisib Pertuzumab/trastuzumab/hyaluronidase-zzxf Atezolizumab Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE) Recruiting DEU 0
NCT05300048 Phase I Serabelisib Nab-paclitaxel + Serabelisib Combination of Serabelisib and Insulin Suppressing Diet With or Without Nab-paclitaxel in Subjects With Advanced Solid Tumors With PIK3CA Mutations Active, not recruiting USA 0
NCT05843253 Phase II Everolimus + Ribociclib Study of Ribociclib and Everolimus in HGG and DIPG Not yet recruiting USA | NLD | GBR | DEU | CAN | AUS 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
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
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
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
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 Active, not recruiting USA 0
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