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NCT02133183

Sapanisertib Before and After Surgery in Treating Patients With Recurrent Glioblastoma

Terminated Phase 1 Last updated 4 April 2024
What this trial tests

Phase 1 trial testing Laboratory Biomarker Analysis in Glioblastoma in 40 participants. Terminated before completion.

Timeline
2 July 2014
Primary endpoint
31 January 2020
31 October 2023

Quick facts

Lead sponsorNational Cancer Institute (NCI)
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment40
Start date2 July 2014
Primary completion31 January 2020
Estimated completion31 October 2023
Sites10 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Glioblastoma or Gliosarcoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This partially randomized pilot phase I trial studies how much sapanisertib reaches the brain tumor and how well it works when given before and after surgery in treating patients with glioblastoma that has grown or come back and requires surgery. Sapanisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Glioblastoma in adults: a Society for Neuro-Oncology (SNO) and European Society of Neuro-Oncology (EANO) consensus review on current management and future directions.
    Wen PY, Weller M, Lee EQ, Alexander BM, et al · · 2020 · cited 908× · PMID 32328653 · DOI 10.1093/neuonc/noaa106
  2. Current Challenges and Opportunities in Treating Glioblastoma.
    Shergalis A, Bankhead A, Luesakul U, Muangsin N, et al · · 2018 · cited 612× · PMID 29669750 · DOI 10.1124/pr.117.014944
  3. Tumorsphere as an effective in vitro platform for screening anti-cancer stem cell drugs.
    Lee CH, Yu CC, Wang BY, Chang WW. · · 2016 · cited 128× · PMID 26527320 · DOI 10.18632/oncotarget.6261
  4. The dual mTOR kinase inhibitor TAK228 inhibits tumorigenicity and enhances radiosensitization in diffuse intrinsic pontine glioma.
    Miyahara H, Yadavilli S, Natsumeda M, Rubens JA, et al · · 2017 · cited 53× · PMID 28450157 · DOI 10.1016/j.canlet.2017.04.019
  5. Treating recurrent glioblastoma: an update.
    Kamiya-Matsuoka C, Gilbert MR. · · 2015 · cited 52× · PMID 25768333 · DOI 10.2217/cns.14.55
  6. mTORC1-Mediated Inhibition of 4EBP1 Is Essential for Hedgehog Signaling-Driven Translation and Medulloblastoma.
    Wu CC, Hou S, Orr BA, Kuo BR, et al · · 2017 · cited 51× · PMID 29103956 · DOI 10.1016/j.devcel.2017.10.011
  7. Phase 0 and window of opportunity clinical trial design in neuro-oncology: a RANO review.
    Vogelbaum MA, Krivosheya D, Borghei-Razavi H, Sanai N, et al · · 2020 · cited 50× · PMID 32598442 · DOI 10.1093/neuonc/noaa149
  8. Inhibiting 4EBP1 in Glioblastoma.
    Fan QW, Nicolaides TP, Weiss WA. · · 2018 · cited 40× · PMID 28696243 · DOI 10.1158/1078-0432.ccr-17-0042

Verify or expand the search:

Other trials of Laboratory Biomarker Analysis

Trials testing the same drug.

Other recruiting trials for Glioblastoma

Currently open trials in the same condition.

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

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Data sources for this page

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