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Gene | PIK3CA |
Variant | act mut |
Impact List | unknown |
Protein Effect | gain of function |
Gene Variant Descriptions | PIK3CA act mut indicates that this variant results in a gain of function in the Pik3ca protein. However, the specific amino acid change has not been identified. |
Associated Drug Resistance | |
Category Variants Paths |
PIK3CA mutant PIK3CA act mut |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
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 |
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 |
NCT03673787 | Phase Ib/II | Atezolizumab + Ipatasertib | A Trial of Ipatasertib in Combination With Atezolizumab (IceCAP) | Unknown status | GBR | 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) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 4 |
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 |
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 |
NCT05843253 | Phase II | Everolimus + Ribociclib | Study of Ribociclib and Everolimus in HGG and DIPG | Recruiting | USA | NLD | GBR | DEU | CAN | AUS | 0 |
NCT03941782 | Phase 0 | Alpelisib | Compassionate Use of BYL 719 Alpelisib | No longer available | 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 |
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 | AUS | 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 |
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 |
NCT05010096 | Phase I | Copanlisib + Elimusertib | BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors | Withdrawn | 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 |
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 |
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 |
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 |
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 |
NCT01833169 | Phase II | Buparlisib | BKM120 for Patients With PI3K-activated Tumors | Completed | USA | 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 |
NCT05392608 | Phase II | Alpelisib + Fulvestrant | SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast) (SEQUEL-Breast) | Recruiting | NLD | 0 |
NCT02549989 | Phase II | LY3023414 | Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer | Completed | 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 | Active, not recruiting | USA | CAN | 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 |
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 |