^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    BIOMARKER:

    PIK3CA mutation

    i
    Entrez ID:
    5290
    Related biomarkers:
    Expression
    Mutation
    CNA
    Others
    Related tests:
    Apply
    A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Indications of RP903 (NCT06846099)
    Phase 1
    Risen (Suzhou) Pharma Tech Co., Ltd.
    Recruiting
    Last update posted :
    02/25/2025
    Initiation :
    12/07/2022
    Primary completion :
    12/31/2025
    Completion :
    12/31/2025
    PIK3CA
    |
    PIK3CA mutation
    Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET) (NCT05063786)
    Phase 3
    Spanish Breast Cancer Research Group
    Active, not recruiting
    Last update posted :
    02/24/2025
    Initiation :
    09/14/2021
    Primary completion :
    06/01/2025
    Completion :
    06/01/2025
    HER-2 • ER • PIK3CA • PGR
    |
    ER positive • PIK3CA mutation
    |
    Herceptin (trastuzumab) • capecitabine • Piqray (alpelisib) • fulvestrant • Halaven (eribulin mesylate) • vinorelbine tartrate • Navelbine oral (vinorelbine tartrate oral)
    Testing the Addition of Copanlisib to Eribulin in Metastatic Triple Negative Breast Cancer (NCT04345913)
    Phase 1/2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/21/2025
    Initiation :
    03/01/2021
    Primary completion :
    06/30/2025
    Completion :
    06/30/2025
    ER • PIK3CA • PGR • PTEN
    |
    HER-2 amplification • HER-2 negative • PIK3CA mutation
    |
    Halaven (eribulin mesylate) • Aliqopa (copanlisib)
    First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors (STX-478-101) (NCT05768139)
    Phase 1/2
    Scorpion Therapeutics, Inc.
    Recruiting
    Last update posted :
    02/21/2025
    Initiation :
    04/17/2023
    Primary completion :
    02/28/2027
    Completion :
    02/28/2029
    PIK3CA
    |
    PIK3CA mutation
    |
    Ibrance (palbociclib) • Kisqali (ribociclib) • fulvestrant • STX-478
    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) (NCT05038735)
    Phase 3
    Novartis Pharmaceuticals
    Recruiting
    Last update posted :
    02/18/2025
    Initiation :
    12/17/2021
    Primary completion :
    12/30/2025
    Completion :
    12/29/2027
    HER-2 • ER • PIK3CA
    |
    HER-2 negative • PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant
    Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer (ELEVATE) (NCT05563220)
    Phase 1/2
    Stemline Therapeutics, Inc.
    Recruiting
    Last update posted :
    02/18/2025
    Initiation :
    01/24/2023
    Primary completion :
    12/27/2026
    Completion :
    12/28/2028
    HER-2 • ER • PIK3CA • CDK4
    |
    PIK3CA mutation
    |
    Ibrance (palbociclib) • everolimus • Piqray (alpelisib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • Truqap (capivasertib) • Orserdu (elacestrant)
    Study of Ribociclib and Everolimus in HGG and DIPG (NCT05843253)
    Phase 2
    Nationwide Children's Hospital
    Recruiting
    Last update posted :
    02/17/2025
    Initiation :
    08/22/2024
    Primary completion :
    08/28/2028
    Completion :
    08/28/2034
    PIK3CA • PTEN • CDKN2A • RB1 • CCND1 • CDK4 • CDKN2B • PIK3R1 • CDK6 • CCND2 • CDKN2C
    |
    PIK3CA mutation • CDKN2A deletion
    |
    everolimus • Kisqali (ribociclib)
    Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer (GeparPiPPa) (NCT05306041)
    Phase 2
    German Breast Group
    Recruiting
    Last update posted :
    02/17/2025
    Initiation :
    01/02/2023
    Primary completion :
    10/01/2026
    Completion :
    01/01/2027
    HER-2 • PIK3CA • PGR
    |
    HER-2 positive • PIK3CA mutation • PGR positive
    |
    Herceptin (trastuzumab) • tamoxifen • Perjeta (pertuzumab) • Itovebi (inavolisib) • Phesgo (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) (NCT05894239)
    Phase 3
    Hoffmann-La Roche
    Recruiting
    Last update posted :
    02/14/2025
    Initiation :
    07/28/2023
    Primary completion :
    09/28/2026
    Completion :
    12/28/2032
    HER-2 • PIK3CA
    |
    HER-2 positive • PIK3CA mutation
    |
    tamoxifen • fulvestrant • Itovebi (inavolisib) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
    Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment. (SOLAR-1) (NCT02437318)
    Phase 3
    Novartis Pharmaceuticals
    Completed
    Last update posted :
    02/13/2025
    Initiation :
    07/23/2015
    Primary completion :
    06/12/2018
    Completion :
    06/09/2023
    HER-2 • ER • PIK3CA
    |
    ER positive • HER-2 negative • PIK3CA mutation • HER-2 negative + ER positive
    |
    Piqray (alpelisib) • fulvestrant
    IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors (NCT05039801)
    Phase 1
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    02/10/2025
    Initiation :
    09/09/2021
    Primary completion :
    05/29/2026
    Completion :
    05/29/2026
    PD-L1 • PIK3CA • PTEN • STK11 • ARID1A • NF1 • KEAP1 • PD-1 • NFE2L2
    |
    PIK3CA mutation • ARID1A mutation • STK11 mutation • KEAP1 mutation • NFE2L2 mutation
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • paclitaxel • Truqap (capivasertib) • IPN60090
    Combination Chemotherapy and Bevacizumab With the NovoTTF-100L(P) System in Treating Participants With Advanced, Recurrent, or Refractory Hepatic Metastatic Cancer (NCT03203525)
    Phase 1
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    02/10/2025
    Initiation :
    06/23/2020
    Primary completion :
    12/31/2026
    Completion :
    12/31/2026
    PIK3CA • PTEN
    |
    PIK3CA mutation
    |
    Avastin (bevacizumab) • 5-fluorouracil • oxaliplatin • Torisel (temsirolimus) • pegylated liposomal doxorubicin • leucovorin calcium • Mvasi (bevacizumab-awwb) • Vegzelma (bevacizumab-adcd) • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin) • fluorouracil topical • Airuituo (bevacizumab biosimilar) • Beianting (bevacizumab biosimilar) • Boyounuo (bevacizumab biosimilar) • Hanbeitai (bevacizumab biosimilar) • Vasforda (bevacizumab biosimilar) • doxorubicin liposomal
    A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (Morpheus-TNBC) (NCT03424005)
    Phase 1/2
    Hoffmann-La Roche
    Recruiting
    Last update posted :
    02/10/2025
    Initiation :
    03/30/2018
    Primary completion :
    05/03/2028
    Completion :
    05/03/2028
    HER-2 • PD-L1 • PIK3CA
    |
    PD-L1 expression • PIK3CA mutation
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • carboplatin • gemcitabine • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • Verzenio (abemaciclib) • albumin-bound paclitaxel • Kisqali (ribociclib) • fulvestrant • Halaven (eribulin mesylate) • letrozole • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Itovebi (inavolisib) • Actemra IV (tocilizumab) • ladiratuzumab vedotin (SGN-LIV1A) • selicrelumab (RG7876)
    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 (NCT04317105)
    Phase 1/2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/06/2025
    Initiation :
    07/17/2020
    Primary completion :
    12/31/2025
    Completion :
    12/31/2025
    PD-L1 • PIK3CA • PTEN
    |
    PIK3CA mutation
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Aliqopa (copanlisib) • CS1002 (ipilimumab biosimilar) • ABP 206 (nivolumab biosimilar) • CMAB 819 (nivolumab biosimilar)
    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) (NCT04191499)
    Phase 2/3
    Hoffmann-La Roche
    Active, not recruiting
    Last update posted :
    02/04/2025
    Initiation :
    01/29/2020
    Primary completion :
    09/29/2023
    Completion :
    09/30/2030
    HER-2 • PIK3CA
    |
    HER-2 negative • PIK3CA mutation
    |
    Ibrance (palbociclib) • fulvestrant • Itovebi (inavolisib)
    Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib (SAFIR 03) (NCT05625087)
    Phase 2
    UNICANCER
    Recruiting
    Last update posted :
    01/30/2025
    Initiation :
    10/19/2023
    Primary completion :
    07/01/2028
    Completion :
    06/01/2030
    HER-2 • ER • PIK3CA • PGR
    |
    HR positive • HER-2 overexpression • HER-2 negative • PIK3CA mutation • HER-2 overexpression + HR positive
    |
    Piqray (alpelisib) • Kisqali (ribociclib) • fulvestrant • triptorelin
    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) (NCT05646862)
    Phase 3
    Hoffmann-La Roche
    Active, not recruiting
    Last update posted :
    01/29/2025
    Initiation :
    06/07/2023
    Primary completion :
    03/30/2029
    Completion :
    03/30/2029
    HER-2 • PIK3CA • CDK4
    |
    HER-2 negative • PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant • Itovebi (inavolisib)
    First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, As a Single Agent in Advanced Solid Tumor Patients and in Combination with Fulvestrant in Patients with Advanced Breast Cancer (ReDiscover) (NCT05216432)
    Phase 1
    Relay Therapeutics, Inc.
    Recruiting
    Last update posted :
    01/29/2025
    Initiation :
    12/08/2021
    Primary completion :
    12/31/2025
    Completion :
    08/31/2026
    HER-2 • PIK3CA • BRCA1 • BRCA2
    |
    HER-2 negative • PIK3CA mutation
    |
    Ibrance (palbociclib) • Piqray (alpelisib) • Kisqali (ribociclib) • fulvestrant • RLY-2608 • atirmociclib (PF-07220060)
    Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients with Progressive Meningiomas (A071401) (NCT02523014)
    Phase 2
    Alliance for Clinical Trials in Oncology
    Recruiting
    Last update posted :
    01/15/2025
    Initiation :
    09/28/2015
    Primary completion :
    01/01/2026
    Completion :
    01/01/2028
    PIK3CA • PTEN • CDKN2A • AKT1 • CCND1 • CCNE1 • PTCH1 • CDK4 • NF2 • SMO • CDK6 • CCND2 • CCND3
    |
    PIK3CA mutation • PTEN mutation
    |
    Verzenio (abemaciclib) • Truqap (capivasertib) • Erivedge (vismodegib) • GSK2256098
    Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer (PATINA) (NCT02947685)
    Phase 3
    Alliance Foundation Trials, LLC.
    Active, not recruiting
    Last update posted :
    01/13/2025
    Initiation :
    06/21/2017
    Primary completion :
    10/15/2024
    Completion :
    07/31/2026
    PIK3CA • PGR
    |
    HER-2 positive • HR positive • PIK3CA mutation
    |
    Herceptin (trastuzumab) • Ibrance (palbociclib) • Perjeta (pertuzumab) • fulvestrant • letrozole • anastrozole • exemestane
    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) (NCT04208178)
    Phase 3
    Novartis Pharmaceuticals
    Active, not recruiting
    Last update posted :
    01/07/2025
    Initiation :
    07/16/2020
    Primary completion :
    12/15/2025
    Completion :
    12/15/2025
    HER-2 • PIK3CA
    |
    HER-2 positive • PIK3CA mutation
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • Piqray (alpelisib)
    A Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Chinese Participants With HER2-Positive Early Breast Cancer (NCT04024462)
    Phase 3
    Hoffmann-La Roche
    Active, not recruiting
    Last update posted :
    12/20/2024
    Initiation :
    02/05/2020
    Primary completion :
    12/13/2021
    Completion :
    11/11/2025
    PIK3CA
    |
    HER-2 positive • HER-2 amplification • PIK3CA mutation • EGFR positive
    |
    Herceptin (trastuzumab) • docetaxel • tamoxifen • doxorubicin hydrochloride • cyclophosphamide • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk) • cyclophosphamide intravenous
    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 (GO39374) (NCT03006172)
    Phase 1
    Genentech, Inc.
    Active, not recruiting
    Last update posted :
    12/20/2024
    Initiation :
    12/13/2016
    Primary completion :
    12/31/2026
    Completion :
    12/31/2026
    HER-2 • PIK3CA
    |
    HER-2 negative • PIK3CA mutation
    |
    Herceptin (trastuzumab) • Ibrance (palbociclib) • Perjeta (pertuzumab) • fulvestrant • letrozole • metformin • Itovebi (inavolisib)
    A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer (GOG-3069) (NCT05154487)
    Phase 2
    GOG Foundation
    Recruiting
    Last update posted :
    12/19/2024
    Initiation :
    09/11/2024
    Primary completion :
    04/01/2025
    Completion :
    04/01/2026
    ER • PIK3CA • MSI
    |
    PIK3CA mutation
    |
    Piqray (alpelisib) • 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 (NCT05082025)
    Phase 2
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    12/18/2024
    Initiation :
    09/27/2022
    Primary completion :
    10/29/2026
    Completion :
    10/29/2026
    ER • PIK3CA • PGR • PTEN • PIK3R1 • PI3K
    |
    ER positive • PIK3CA mutation • PTEN deletion
    |
    fulvestrant • Aliqopa (copanlisib)
    PIK3CA Mutational Status Assessment (NCT06706570)
    Phase N/A
    European Institute of Oncology
    Recruiting
    Last update posted :
    11/26/2024
    Initiation :
    11/06/2024
    Primary completion :
    12/31/2026
    Completion :
    12/31/2030
    PIK3CA
    |
    PIK3CA mutation
    Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer (BTCRC-BRE19-409) (NCT04762979)
    Phase 2
    Marina N Sharifi
    Recruiting
    Last update posted :
    10/30/2024
    Initiation :
    02/12/2021
    Primary completion :
    09/01/2025
    Completion :
    01/01/2026
    HER-2 • PIK3CA
    |
    HER-2 amplification • HER-2 negative • PIK3CA mutation • HR positive + HER-2 negative
    |
    Piqray (alpelisib) • fulvestrant
    A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors (PIKASSO-01) (NCT05307705)
    Phase 1
    Eli Lilly and Company
    Active, not recruiting
    Last update posted :
    10/26/2024
    Initiation :
    05/11/2022
    Primary completion :
    05/01/2025
    Completion :
    05/01/2025
    HER-2 • ER • PIK3CA
    |
    HER-2 negative • PIK3CA mutation
    |
    paclitaxel • Verzenio (abemaciclib) • fulvestrant • letrozole • anastrozole • exemestane • Inluriyo (imlunestrant) • LOXO-783
    Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Mutations or Fusions (MATCH - Subprotocol K2) (EAY131-K2) (NCT06351371)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    10/14/2024
    Initiation :
    07/03/2018
    Primary completion :
    06/02/2022
    Completion :
    12/31/2025
    PIK3CA
    |
    PIK3CA mutation
    |
    Balversa (erdafitinib)
    Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer (NCT02228681)
    Phase 2
    GOG Foundation
    Completed
    Last update posted :
    09/19/2024
    Initiation :
    05/21/2015
    Primary completion :
    01/01/2018
    Completion :
    08/22/2024
    PIK3CA • PGR • PTEN • CTNNB1
    |
    KRAS mutation • PIK3CA mutation
    |
    everolimus • tamoxifen • letrozole
    Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Amplifications (MATCH-Subprotocol K1) (EAY131-K1) (NCT06308822)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    09/16/2024
    Initiation :
    08/20/2018
    Primary completion :
    07/27/2022
    Completion :
    12/31/2025
    PIK3CA
    |
    PIK3CA mutation
    |
    Balversa (erdafitinib)
    A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With Select Solid Tumors (NCT05683418)
    Phase 1
    Totus Medicines
    Recruiting
    Last update posted :
    06/10/2024
    Initiation :
    02/15/2023
    Primary completion :
    12/01/2025
    Completion :
    12/01/2025
    HER-2 • PIK3CA
    |
    HER-2 negative • PIK3CA mutation
    |
    TOS-358
    PIK3CA/PTEN-altered Advanced Breast Cancer Treated With MEN1611 Monotherapy or in Combination With Eribulin (SABINA) (NCT05810870)
    Phase 2
    MedSIR
    Recruiting
    Last update posted :
    06/03/2024
    Initiation :
    05/24/2023
    Primary completion :
    07/01/2025
    Completion :
    07/01/2027
    PIK3CA • PTEN
    |
    PIK3CA mutation
    |
    Halaven (eribulin mesylate) • izorlisib (MEN1611)
    Leflunomide in Previously Treated Metastatic Triple Negative Cancers (NCT03709446)
    Phase 1/2
    Joseph Sparano
    Recruiting
    Last update posted :
    05/30/2024
    Initiation :
    04/16/2019
    Primary completion :
    10/01/2025
    Completion :
    10/01/2026
    HER-2 • ER • PIK3CA
    |
    ER positive • HER-2 negative • PIK3CA mutation
    |
    leflunomide
    A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population (MiRaDoR) (NCT05708235)
    Phase 2
    MedSIR
    Recruiting
    Last update posted :
    05/29/2024
    Initiation :
    04/01/2024
    Primary completion :
    12/30/2028
    Completion :
    12/30/2028
    HER-2 • PIK3CA
    |
    HR positive • HER-2 negative • PIK3CA mutation
    |
    Verzenio (abemaciclib) • Itovebi (inavolisib) • giredestrant (GDC-9545)
    Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F) (NCI-2022-06209) (NCT05490771)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    05/23/2024
    Initiation :
    06/20/2018
    Primary completion :
    01/06/2021
    Completion :
    12/31/2025
    PIK3CA
    |
    PIK3CA mutation
    |
    Aliqopa (copanlisib)
    Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Women With a PI3K Alteration and HR+/Her2- Breast Cancer (Amelia-1) (NCT05455619)
    Phase 1/2
    SynDevRx, Inc.
    Recruiting
    Last update posted :
    05/22/2024
    Initiation :
    08/26/2022
    Primary completion :
    03/01/2026
    Completion :
    09/01/2026
    HER-2 • PIK3CA
    |
    HER-2 negative • PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant • evexomostat (SDX-7320)
    Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer (PULSE) (NCT03992456)
    Phase 2
    Academic and Community Cancer Research United
    Active, not recruiting
    Last update posted :
    05/21/2024
    Initiation :
    04/24/2020
    Primary completion :
    12/01/2023
    Completion :
    10/07/2024
    EGFR • HER-2 • KRAS • BRAF • PIK3CA • MET • NRAS • MSI • PTEN • CD73 • TGFA
    |
    KRAS mutation • EGFR mutation • MSI-H/dMMR • HER-2 amplification • PIK3CA mutation • MET amplification • KRAS wild-type • NRAS wild-type
    |
    Vectibix (panitumumab) • Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil)
    Superselective Intra-arterial Cerebral Infusion of Temsirolimus in HGG (NCT05773326)
    Phase 1
    Nader Sanai
    Recruiting
    Last update posted :
    05/21/2024
    Initiation :
    05/15/2023
    Primary completion :
    04/30/2025
    Completion :
    04/30/2026
    PIK3CA • PTEN • mTOR • PIK3R1 • PIK3C2B
    |
    PIK3CA mutation • MTOR mutation • PIK3CA mutation + PTEN mutation • PIK3R1 mutation
    |
    Torisel (temsirolimus)
    Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations (NCI10217) (NCT03842228)
    Phase 1
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    05/17/2024
    Initiation :
    11/21/2019
    Primary completion :
    12/31/2024
    Completion :
    12/31/2024
    PIK3CA • BRCA1 • BRCA2 • RAD51 • FANCA • RAD51B • BRIP1 • RAD51C • CD4 • RAD51D • BARD1 • NBN
    |
    PIK3CA mutation • PTEN mutation • PALB2 mutation • CDK12 mutation • PIK3CA E545 • PIK3CA H1047 • BARD1 mutation • PIK3CA E542 • RAD51 mutation
    |
    Lynparza (olaparib) • Imfinzi (durvalumab) • Aliqopa (copanlisib)
    MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer (B-PRECISE-01) (NCT03767335)
    Phase 1
    Menarini Group
    Completed
    Last update posted :
    05/16/2024
    Initiation :
    07/19/2018
    Primary completion :
    01/22/2024
    Completion :
    02/23/2024
    PIK3CA
    |
    PIK3CA mutation
    |
    Herceptin (trastuzumab) • fulvestrant • izorlisib (MEN1611)