Phase 1 study of mTORC1/2 inhibitor sapanisertib (TAK-228) in advanced solid tumours, with an expansion phase in renal, endometrial or ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2020-09-11

AUTHORS

Martin H. Voss, Michael S. Gordon, Monica Mita, Brian Rini, Vicky Makker, Teresa Macarulla, David C. Smith, Andrés Cervantes, Igor Puzanov, Roberto Pili, Ding Wang, Shadia Jalal, Shubham Pant, Manish R. Patel, Rachel l. Neuwirth, Aaron Enke, Yaping Shou, Farhad Sedarati, Douglas V. Faller, Howard A. Burris

ABSTRACT

BackgroundThis Phase 1 dose-escalation/expansion study assessed safety/tolerability of sapanisertib, an oral, highly selective inhibitor of mTORC1/mTORC2, in advanced solid tumours.MethodsEligible patients received increasing sapanisertib doses once daily (QD; 31 patients), once weekly (QW; 30 patients), QD for 3 days on/4 days off QW (QD × 3dQW; 33 patients) or QD for 5 days on/2 days off QW (QD × 5dQW; 22 patients). In expansion cohorts, 82 patients with renal cell carcinoma (RCC), endometrial or bladder cancer received sapanisertib 5 mg QD (39 patients), 40 mg QW (26 patients) or 30 mg QW (17 patients).ResultsMaximum tolerated doses of sapanisertib were 6 mg QD, 40 mg QW, 9 mg QD × 3dQW and 7 mg QD × 5dQW. Frequent dose-limiting toxicities (DLTs) included hyperglycaemia, maculo-papular rash (QD), asthenia and stomatitis (QD × 3dQW/QD × 5dQW); expansion phase doses of 5 mg QD and 30 mg QW were selected based on tolerability beyond the DLT evaluation period. One patient with RCC achieved complete response; nine experienced partial responses (RCC: seven patients; carcinoid tumour/endometrial cancer: one patient each). Sapanisertib pharmacokinetics were time-linear and supported multiple dosing. Pharmacodynamic findings demonstrated treatment-related reductions in TORC1/2 biomarkers.ConclusionsSapanisertib demonstrated a manageable safety profile, with preliminary antitumour activity observed in RCC and endometrial cancer.Clinical trial registrationClinicalTrials.gov, NCT01058707. More... »

PAGES

1590-1598

Journal

TITLE

British Journal of Cancer

ISSUE

11

VOLUME

123

Author Affiliations

  • Department of Medicine, 300 East 66th Street, Memorial Sloan Kettering Cancer Center, 10065, New York, NY, USA
  • Oncology Research, HonorHealth Research Institute, 10510 N 92nd St Suite 200, 85258, Scottsdale, AZ, USA
  • Department of Hematology and Oncology, Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, 8700 Beverly Blvd North Tower, 90048, Los Angeles, CA, USA
  • Cleveland Clinic Foundation, Department of Solid Tumor Oncology, 9500 Euclid Avenue, 44195, Cleveland, OH, USA
  • Medical Oncology Department, Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology (VHIO), Passeig de la Vall d’Hebron, 119, 129, 08035, Barcelona, Spain
  • University of Michigan, Department of Internal Medicine, 1500 E. Medical Center Drive, 48109, Ann Arbor, MI, USA
  • CIBERONC, Department of Medical Oncology, Biomedical Research Institute INCLIVA, University of Valencia, Avda. Menéndez Pelayo 4 acc., 46010, Valencia, Spain
  • Clovis Oncology, San Francisco, CA, USA
  • Indiana University—Simon Cancer Center, Department of Medicine, Division of Hematology/Oncology, 535 Barnhill Drive, 46202, Indianapolis, IN, USA
  • Henry Ford Health System, Hematology/Oncology, 1 Ford Pl, 48202, Detroit, MI, USA
  • Indiana University Melvin and Bren Simon Cancer Center, Hematology/Oncology, 535 Barnhill Drive, 46202, Indianapolis, IN, USA
  • Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, 77030, Houston, TX, USA
  • Florida Cancer Specialists/SCRI, Drug Development Unit, 600 N Cattlemen Rd #200, 34232, Sarasota, FL, USA
  • Biostatistics, Millennium Pharmaceuticals, Inc., 40 Landsdowne Street, 02139, Cambridge, MA, USA
  • Trillium Therapeutics Inc., Cambridge, MA, USA
  • Oncology Clinical Research, Millennium Pharmaceuticals Inc., 40 Landsdowne Street, 02139, Cambridge, MA, USA
  • Sarah Cannon Research Institute/Tennessee Oncology, Drug Development Unit, 250 25th Ave., 37203, North Nashville, TN, USA
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1038/s41416-020-01041-x

    DOI

    http://dx.doi.org/10.1038/s41416-020-01041-x

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1130749065

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/32913286


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