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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 |
|---|---|---|---|---|---|---|
| NCT05154487 | Phase II | Alpelisib + Fulvestrant | A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer | Recruiting | USA | 0 |
| NCT05039801 | Phase I | Capivasertib + IACS-6274 Bevacizumab + IACS-6274 + Paclitaxel IACS-6274 | IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors | Recruiting | USA | 0 |
| NCT06993844 | Phase Ib/II | ETX-636 ETX-636 + Fulvestrant | Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors | Recruiting | USA | 0 |
| NCT06764186 | Phase III | Capivasertib + Fulvestrant | A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain (CAPItana) | Recruiting | ESP | 0 |
| NCT03673787 | Phase Ib/II | Atezolizumab + Ipatasertib | A Trial of Ipatasertib in Combination With Atezolizumab (IceCAP) | Active, not recruiting | GBR | 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 |
| NCT01833169 | Phase II | Buparlisib | BKM120 for Patients With PI3K-activated Tumors | Completed | USA | 0 |
| NCT06736704 | Phase I | Fulvestrant + SNV4818 SNV4818 | SNV4818 in Participants with Advanced Solid Tumors | Recruiting | USA | CAN | AUS | 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 |
| NCT07174336 | Phase III | Letrozole + Palbociclib Fulvestrant + Palbociclib + STX-478 Anastrozole + Palbociclib Fulvestrant + Ribociclib + STX-478 Abemaciclib + Anastrozole + STX-478 Letrozole + Palbociclib + STX-478 Abemaciclib + Exemestane + STX-478 Letrozole + Ribociclib + STX-478 Abemaciclib + Fulvestrant + STX-478 Fulvestrant + Palbociclib Exemestane + Palbociclib Anastrozole + Palbociclib + STX-478 Abemaciclib + Letrozole + STX-478 Anastrozole + Ribociclib + STX-478 Exemestane + Palbociclib + STX-478 Exemestane + Ribociclib + STX-478 | A Study of LY4064809 With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) | Recruiting | USA | TUR | ITA | GRC | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS | ARG | 3 |
| 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) | Completed | USA | 1 |
| NCT05216432 | Phase I | Fulvestrant + Ribociclib + RLY-2608 RLY-2608 Fulvestrant + RLY-2608 Fulvestrant + Palbociclib + RLY-2608 Fulvestrant + PF-07220060 + 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 |
| 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 | Completed | USA | 0 |
| NCT05843253 | Phase II | Ribociclib + Temozolomide Everolimus + Ribociclib | Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant | Recruiting | USA | NLD | GBR | DEU | CAN | AUS | 0 |
| NCT05307705 | Phase I | Abemaciclib + Anastrozole + LOXO-783 Abemaciclib + Exemestane + LOXO-783 Abemaciclib + Letrozole + LOXO-783 LOXO-783 + Paclitaxel Fulvestrant + LOXO-783 Imlunestrant + LOXO-783 Abemaciclib + Fulvestrant + LOXO-783 Abemaciclib + Imlunestrant + LOXO-783 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 | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 4 |
| 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 |
| NCT06982521 | Phase III | Fulvestrant + RLY-2608 Capivasertib + Fulvestrant | Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer (ReDiscover-2) | 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 | 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 |
| 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 |
| NCT05392608 | Phase II | Alpelisib + Fulvestrant | SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast) (SEQUEL-Breast) | Active, not recruiting | NLD | 0 |
| NCT04486352 | Phase Ib/II | Atezolizumab + Talazoparib Atezolizumab + Ipatasertib Abemaciclib + Giredestrant Inavolisib + Letrozole | A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer (EndoMAP) | 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 |
| NCT02549989 | Phase II | LY3023414 | Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer | Completed | 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 |
| 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 | Terminated | USA | 0 |
| NCT04551521 | Phase II | Atezolizumab Atezolizumab + Ipatasertib Atezolizumab + Pertuzumab + Trastuzumab Atezolizumab + Cobimetinib Alectinib Atezolizumab + Cobimetinib + Vemurafenib | CRAFT: The NCT-PMO-1602 Phase II Trial | Completed | DEU | 0 |
| NCT03941782 | Phase 0 | Alpelisib | Compassionate Use of BYL 719 Alpelisib | No longer available | USA | 0 |
| NCT05111561 | Phase I | Binimetinib + ZEN-3694 | Testing the Combination of the Anticancer Drugs ZEN003694 and Binimetinib in Patients With Advanced/Metastatic or Unresectable Solid Tumors With RAS Alterations and Triple Negative Breast Cancer | Suspended | USA | 0 |
| NCT05010096 | Phase I | Copanlisib + Elimusertib | BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors | Withdrawn | 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 |
| 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 | Completed | USA | 0 |