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    DRUG CLASS:

    mTOR inhibitor

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    Comparison of Single-Agent Carboplatin Vs the Combination of Carboplatin and Everolimus for the Treatment of Advanced Triple-Negative Breast Cancer (NCT02531932)
    Phase 2
    Amy Tiersten
    Completed
    Last update posted :
    02/19/2025
    Initiation :
    12/16/2015
    Primary completion :
    09/30/2024
    Completion :
    10/19/2024
    HER-2
    |
    carboplatin • everolimus
    Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain Cancers (NCT03190174)
    Phase 1/2
    Sarcoma Oncology Research Center, LLC
    Completed
    Last update posted :
    02/17/2025
    Initiation :
    08/24/2017
    Primary completion :
    12/01/2021
    Completion :
    12/02/2021
    MSI
    |
    MSI-H/dMMR
    |
    Opdivo (nivolumab) • sirolimus • Fyarro (nanoparticle albumin-bound rapamycin)
    Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations (NCT03047213)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/12/2025
    Initiation :
    08/24/2017
    Primary completion :
    10/06/2020
    Completion :
    11/11/2025
    TSC2 • TSC1
    |
    TSC1 mutation • TSC2 mutation
    |
    sapanisertib (CB-228)
    Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation (NCI-2017-01311) (NCT03246906)
    Phase 2
    Fred Hutchinson Cancer Center
    Active, not recruiting
    Last update posted :
    02/05/2025
    Initiation :
    09/11/2017
    Primary completion :
    05/03/2025
    Completion :
    05/03/2025
    HLA-DRB1 • HLA-DQB1 • HLA-B • HLA-C
    |
    cyclophosphamide • sirolimus • cyclosporin A microemulsion • cyclophosphamide intravenous
    Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer (NCT00980460)
    Phase 3
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/04/2025
    Initiation :
    09/14/2009
    Primary completion :
    06/30/2020
    Completion :
    03/05/2025
    AFP
    |
    AFP elevation
    |
    cisplatin • 5-fluorouracil • doxorubicin hydrochloride • irinotecan • Torisel (temsirolimus) • vincristine • fluorouracil topical • dexrazoxane
    Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma (ARST1431) (NCT02567435)
    Phase 3
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/04/2025
    Initiation :
    06/01/2016
    Primary completion :
    06/30/2023
    Completion :
    10/16/2025
    FOXO1 • PAX3 • PAX7
    |
    cyclophosphamide • irinotecan • Torisel (temsirolimus) • vincristine • vinorelbine tartrate • dactinomycin
    Sorafenib Tosylate With or Without Everolimus in Treating Patients With Advanced, Radioactive Iodine Refractory Hurthle Cell Thyroid Cancer (A091302) (NCT02143726)
    Phase 2
    Alliance for Clinical Trials in Oncology
    Active, not recruiting
    Last update posted :
    01/27/2025
    Initiation :
    10/09/2014
    Primary completion :
    01/28/2021
    Completion :
    08/06/2028
    TG
    |
    sorafenib • everolimus
    Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) (NCT06757634)
    Phase 3
    Celcuity Inc
    Not yet recruiting
    Last update posted :
    01/07/2025
    Initiation :
    06/30/2025
    Primary completion :
    12/31/2027
    Completion :
    12/30/2028
    PIK3CA
    |
    Ibrance (palbociclib) • Kisqali (ribociclib) • fulvestrant • gedatolisib (PF-05212384)
    A Randomized Study of AZD2014 in Combination With Fulvestrant in Metastatic or Advanced Breast Cancer (MANTA) (NCT02216786)
    Phase 2
    Queen Mary University of London
    Completed
    Last update posted :
    12/02/2024
    Initiation :
    01/16/2014
    Primary completion :
    12/31/2021
    Completion :
    12/31/2021
    HER-2 • ER
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    everolimus • fulvestrant • vistusertib (AZD2014)
    Phase 1b Combo w/ Ribociclib, Alpelisib, or Everolimus (OP-1250-003) (NCT05508906)
    Phase 1
    Olema Pharmaceuticals, Inc.
    Recruiting
    Last update posted :
    10/03/2024
    Initiation :
    08/31/2022
    Primary completion :
    05/20/2026
    Completion :
    06/30/2026
    HER-2
    |
    HER-2 negative
    |
    everolimus • Piqray (alpelisib) • Kisqali (ribociclib) • palazestrant (OP-1250)
    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
    Combination Therapy for the Treatment of Diffuse Midline Gliomas (NCT05009992)
    Phase 2
    University of California, San Francisco
    Recruiting
    Last update posted :
    06/13/2024
    Initiation :
    10/20/2021
    Primary completion :
    12/31/2025
    Completion :
    06/30/2029
    BRAF
    |
    dordaviprone (ONC201) • paxalisib (GDC-0084)
    Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers (BTCRC-BRE18-337) (NCT03911973)
    Phase 1/2
    Kari Wisinski
    Active, not recruiting
    Last update posted :
    06/07/2024
    Initiation :
    04/17/2019
    Primary completion :
    07/01/2024
    Completion :
    07/01/2024
    HER-2 • BRCA1 • BRCA2 • BRCA
    |
    HER-2 negative • BRCA1 negative
    |
    Talzenna (talazoparib) • gedatolisib (PF-05212384)
    Study of AZD2014 and Palbociclib in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer (PASTOR) (NCT02599714)
    Phase 1
    AstraZeneca
    Completed
    Last update posted :
    06/06/2024
    Initiation :
    12/07/2015
    Primary completion :
    03/30/2018
    Completion :
    11/23/2023
    HER-2 • ER
    |
    ER positive • HER-2 negative
    |
    Ibrance (palbociclib) • fulvestrant • vistusertib (AZD2014)
    Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer (NCT06437574)
    Phase 2
    Cedars-Sinai Medical Center
    Not yet recruiting
    Last update posted :
    06/05/2024
    Initiation :
    07/01/2024
    Primary completion :
    02/29/2028
    Completion :
    05/31/2028
    CD8
    |
    sirolimus • ezetimibe/simvastatin
    The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation (NCT05436418)
    Phase 1/2
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    06/05/2024
    Initiation :
    11/18/2022
    Primary completion :
    06/25/2027
    Completion :
    07/02/2027
    IGH • HLA-B • HLA-C
    |
    cyclophosphamide • sirolimus • melphalan • fludarabine IV • mesna • Neupogen (filgrastim)
    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)
    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) (NCT03213678)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    05/21/2024
    Initiation :
    11/28/2017
    Primary completion :
    09/30/2023
    Completion :
    10/01/2024
    PTEN • TSC2 • TSC1
    |
    PTEN expression • TSC1 mutation • TSC2 mutation
    |
    samotolisib (LY3023414)
    mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian (NCT02208375)
    Phase 1/2
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    05/17/2024
    Initiation :
    11/11/2014
    Primary completion :
    12/30/2025
    Completion :
    12/30/2025
    ER • PGR • BRCA • MUC16
    |
    BRCA mutation
    |
    Lynparza (olaparib) • Truqap (capivasertib) • vistusertib (AZD2014)
    Minitransplants With HLA-matched Donors : Comparison Between 2 GVHD Prophylaxis Regimens (NCT01428973)
    Phase 2
    University of Liege
    Active, not recruiting
    Last update posted :
    05/09/2024
    Initiation :
    09/01/2011
    Primary completion :
    12/01/2024
    Completion :
    12/01/2024
    HLA-DRB1 • HLA-B • HLA-C
    |
    sirolimus
    GDC-0084 in Combination With Trastuzumab for Patients With HER2-Positive Breast Cancer Brain Metastases (NCT03765983)
    Phase 2
    Dana-Farber Cancer Institute
    Recruiting
    Last update posted :
    05/07/2024
    Initiation :
    02/11/2019
    Primary completion :
    11/30/2024
    Completion :
    11/30/2025
    HER-2 • EIF4EBP1
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification
    |
    Herceptin (trastuzumab) • paxalisib (GDC-0084)
    GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases (NCT04192981)
    Phase 1
    Memorial Sloan Kettering Cancer Center
    Active, not recruiting
    Last update posted :
    04/17/2024
    Initiation :
    12/06/2019
    Primary completion :
    12/01/2025
    Completion :
    12/01/2025
    PIK3CA • PTEN • AKT1 • PIK3R1 • PIK3CG • PIK3CD • PIK3CB • INPP4B • AKT2 • INPP5D • PIK3C3 • PIK3R2 • PIK3R3
    |
    paxalisib (GDC-0084)
    Safety Study of Adding Everolimus to Adjuvant Hormone Therapy in Women With High Risk of Relapse, ER+ and HER2- Primary Breast Cancer, Free of Disease After Receiving at Least One Year of Adjuvant Hormone Therapy (UNIRAD) (NCT01805271)
    Phase 3
    UNICANCER
    Active, not recruiting
    Last update posted :
    04/10/2024
    Initiation :
    03/01/2013
    Primary completion :
    06/01/2020
    Completion :
    06/01/2030
    HER-2
    |
    HR positive • HER-2 negative • PTEN mutation + HR positive
    |
    everolimus
    CLEVER Pilot Trial: A Phase II Pilot Trial of HydroxyChLoroquine, EVErolimus or the Combination for Prevention of Recurrent Breast Cancer (NCT03032406)
    Phase 2
    Abramson Cancer Center at Penn Medicine
    Active, not recruiting
    Last update posted :
    03/12/2024
    Initiation :
    01/23/2017
    Primary completion :
    05/17/2022
    Completion :
    05/23/2025
    ER • ALK • PGR
    |
    HER-2 negative
    |
    everolimus • hydroxychloroquine
    Everolimus Combined With PD-1 in Advanced Colorectal Cancer Patients (NCT06301386)
    Phase 2
    Fudan University
    Not yet recruiting
    Last update posted :
    03/08/2024
    Initiation :
    04/01/2024
    Primary completion :
    05/01/2026
    Completion :
    12/01/2026
    PD-L1
    |
    everolimus
    A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours (NCT01396408)
    Phase 2
    Canadian Cancer Trials Group
    Active, not recruiting
    Last update posted :
    02/26/2024
    Initiation :
    02/09/2012
    Primary completion :
    07/06/2015
    Completion :
    12/31/2024
    PTEN • STK11 • NF1
    |
    EGFR mutation • PTEN mutation • NF1 mutation • MTOR mutation • AKT1 amplification
    |
    sunitinib • Torisel (temsirolimus)
    Sirolimus in Combination With Metronomic Chemotherapy in Children With Recurrent and/or Refractory Solid and CNS Tumors (AflacST1502) (NCT02574728)
    Phase 2
    Emory University
    Recruiting
    Last update posted :
    02/23/2024
    Initiation :
    06/01/2015
    Primary completion :
    02/01/2025
    Completion :
    02/01/2025
    AFP
    |
    cyclophosphamide • etoposide IV • sirolimus • celecoxib oral • cyclophosphamide intravenous
    Hormone Receptor Positive endometrIal Carcinoma Treated by Dual mTORC1/mTORC2 Inhibitor and Anastrozole (VICTORIA) (NCT02730923)
    Phase 1/2
    Centre Leon Berard
    Active, not recruiting
    Last update posted :
    02/13/2024
    Initiation :
    04/01/2016
    Primary completion :
    11/01/2019
    Completion :
    12/01/2024
    ER • PGR • ABCB1
    |
    PGR positive
    |
    anastrozole • vistusertib (AZD2014)
    Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- SNF1-subtype Advanced Breast Cancer (BCTOP-L-M01) (NCT05949541)
    Phase 2
    Fudan University
    Recruiting
    Last update posted :
    02/08/2024
    Initiation :
    07/26/2023
    Primary completion :
    07/01/2026
    Completion :
    01/01/2028
    HER-2
    |
    HER-2 negative
    |
    everolimus • fulvestrant • exemestane • AiRuiKang (dalpiciclib) • goserelin acetate
    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 (NCT03065062)
    Phase 1
    Dana-Farber Cancer Institute
    Recruiting
    Last update posted :
    02/06/2024
    Initiation :
    02/28/2017
    Primary completion :
    01/01/2025
    Completion :
    01/01/2026
    PIK3CA • PTEN
    |
    PIK3CA mutation
    |
    Ibrance (palbociclib) • gedatolisib (PF-05212384)
    Everolimus With Investigator's Choice of Chemotherapy in Advanced Triple-Negative Breast Cancer (TNBC) With Luminal Androgen Receptor (LAR) Subtype (BCTOP-T-M03) (NCT05954442)
    Phase 3
    Fudan University
    Recruiting
    Last update posted :
    01/15/2024
    Initiation :
    09/13/2023
    Primary completion :
    08/01/2025
    Completion :
    08/01/2026
    HER-2
    |
    carboplatin • everolimus • capecitabine • albumin-bound paclitaxel • Halaven (eribulin mesylate)
    SARC031: MEK Inhibitor Selumetinib (AZD6244) in Combination With the mTOR Inhibitor Sirolimus for Patients With Malignant Peripheral Nerve Sheath Tumors (NCT03433183)
    Phase 2
    Sarcoma Alliance for Research through Collabora...
    Completed
    Last update posted :
    12/25/2023
    Initiation :
    10/02/2019
    Primary completion :
    06/22/2022
    Completion :
    10/01/2023
    NF1
    |
    Koselugo (selumetinib) • sirolimus
    S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer (NCT01674140)
    Phase 3
    SWOG Cancer Research Network
    Active, not recruiting
    Last update posted :
    12/20/2023
    Initiation :
    09/12/2013
    Primary completion :
    12/01/2022
    Completion :
    01/01/2030
    HER-2 • ER • PGR • CD4
    |
    HER-2 negative
    |
    everolimus • tamoxifen • letrozole • anastrozole • exemestane • goserelin acetate • leuprolide acetate for depot suspension • Soltamox (tamoxifen citrate)
    Everolimus for Treatment of Disfiguring Cutaneous Lesions in Neurofibromatosis1 CRAD001CUS232T (DCLNF1) (NCT02332902)
    Phase 2
    The University of Texas Health Science Center, ...
    Completed
    Last update posted :
    12/20/2023
    Initiation :
    02/01/2015
    Primary completion :
    03/01/2016
    Completion :
    03/01/2016
    PTEN • mTOR
    |
    everolimus
    A Study of WX390 in Patients With Advanced Solid Tumors With PIK3CA Mutations (NCT06132932)
    Phase 1/2
    Shanghai Jiatan Pharmatech Co., Ltd
    Completed
    Last update posted :
    11/15/2023
    Initiation :
    06/03/2021
    Primary completion :
    01/03/2023
    Completion :
    01/03/2023
    PIK3CA
    |
    PIK3CA mutation
    Efficacy and Safety of Sirolimus in LAM (MILES) (NCT00414648)
    Phase 3
    University of Cincinnati
    Completed
    Last update posted :
    11/02/2023
    Initiation :
    12/01/2006
    Primary completion :
    09/01/2010
    Completion :
    02/01/2011
    VEGFD
    |
    sirolimus
    Paxalisib With a High Fat, Low Carb Diet and Metformin for Glioblastoma (NCT05183204)
    Phase 2
    Weill Medical College of Cornell University
    Recruiting
    Last update posted :
    09/26/2023
    Initiation :
    02/14/2022
    Primary completion :
    12/01/2024
    Completion :
    12/01/2025
    MGMT
    |
    MGMT promoter methylation
    |
    metformin • paxalisib (GDC-0084)
    Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy (NCT01485861)
    Phase 1/2
    Genentech, Inc.
    Completed
    Last update posted :
    09/14/2023
    Initiation :
    01/11/2012
    Primary completion :
    09/01/2015
    Completion :
    08/31/2022
    PTEN
    |
    PTEN loss
    |
    docetaxel • abiraterone acetate • ipatasertib (RG7440) • prednisone • apitolisib (GDC-0980)
    LY3023414 and Prexasertib in Metastatic Triple-negative Breast Cancer (ExIST) (NCT04032080)
    Phase 2
    Baylor Research Institute
    Completed
    Last update posted :
    09/11/2023
    Initiation :
    09/05/2019
    Primary completion :
    06/01/2022
    Completion :
    11/26/2022
    ER
    |
    ER negative
    |
    prexasertib (ACR-368) • samotolisib (LY3023414)
    Tamoxifen-RAD001 Versus Tamoxifen Alone in Patients With Anti-aromatase Resistant Breast Metastatic Cancer (NCT01298713)
    Phase 2
    ARCAGY/ GINECO GROUP
    Completed
    Last update posted :
    09/06/2023
    Initiation :
    03/01/2008
    Primary completion :
    06/01/2011
    Completion :
    09/12/2018
    HER-2 • ER • PGR
    |
    HER-2 negative • PGR positive
    |
    everolimus • tamoxifen