Last reviewed · How we verify
NCT02133183
Sapanisertib Before and After Surgery in Treating Patients With Recurrent Glioblastoma
Phase 1 trial testing Laboratory Biomarker Analysis in Glioblastoma in 40 participants. Terminated before completion.
31 January 2020
Quick facts
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 2 July 2014 |
| Primary completion | 31 January 2020 |
| Estimated completion | 31 October 2023 |
| Sites | 10 locations across United States |
Drugs / interventions tested
- Laboratory Biomarker Analysis — full drug profile →
- Pharmacological Study — full drug profile →
- Sapanisertib — full drug profile →
- Therapeutic Conventional Surgery
Conditions studied
- Glioblastoma — all drugs for Glioblastoma →
- Gliosarcoma — all drugs for Gliosarcoma →
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):
-
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 -
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 -
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 -
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 -
Treating recurrent glioblastoma: an update.
Kamiya-Matsuoka C, Gilbert MR. · · 2015 · cited 52× · PMID 25768333 · DOI 10.2217/cns.14.55 -
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 -
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 -
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:
- PubMed search for NCT02133183
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Laboratory Biomarker Analysis
Trials testing the same drug.
- NCT04142398 — Incidence of HPV Infection and HPV-Associated Disease in Screening Indian Men Who Have Sex With HIV-Positive Men · withdrawn
- NCT04142385 — Incidence of HIV Infection in Screening Indian Men Who Have Sex With Men · withdrawn
- NCT05558904 — An Investigational Scan (Me-4FDG PET/CT) for the Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cance · Phase 1, PHASE2 · recruiting
- NCT05564650 — Navitoclax in Relapsed or Refractory High-Risk Myelodysplastic Syndrome · Phase 1 · active not recruiting
- NCT05396859 — Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia · Phase 1 · active not recruiting
Other recruiting trials for Glioblastoma
Currently open trials in the same condition.
- NCT07284069 — Senicapoc and Perampanel for Newly Diagnosed Glioblastoma · EARLY_PHASE1 · recruiting
- NCT05653635 — Contribution From PET-DOPA in Glioblastoma Re-irradiation - A Randomized Phase II Study · Phase 2 · recruiting
- NCT07480941 — Dual-Targeting CAR-NK Cells for Recurrent/Progressive Glioblastoma and High-Grade Glioma · Phase 1 · recruiting
- NCT07448480 — Comprehensive Analysis of Chemotherapy and Targeted Therapy Outcomes in Recurrent Malignant Gliomas · active not recruiting
- NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
Other National Cancer Institute (NCI) trials
Trials by the same sponsor.
- NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem · Phase 1, PHASE2 · recruiting
- NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
- NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa · Phase 2 · recruiting
- NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After · Phase 1 · not yet recruiting
- NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02133183 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
- Last refreshed: 4 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02133183.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing