NCT03025893: STELLAR

A Phase II/III Study of High-dose, Intermittent Sunitinib in Patients With Recurrent Glioblastoma Multiforme

Status unknown Phase 2, PHASE3 Last updated 19 April 2021

What this trial tests

Phase 2, PHASE3 trial testing Sunitinib in Glioblastoma Multiforme in 100 participants. Status unknown.

Timeline

31 August 2018

Primary endpoint
1 January 2022

1 January 2022

Quick facts

Lead sponsor	Amsterdam UMC, location VUmc
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	31 August 2018
Primary completion	1 January 2022
Estimated completion	1 January 2022
Sites	3 locations across Netherlands

Drugs / interventions tested

• Sunitinib (sunitinib) — full drug profile →
• Lomustine (LOMUSTINE) — full drug profile →

Conditions studied

• Glioblastoma Multiforme — all drugs for Glioblastoma Multiforme →
• Glioblastoma, Adult — all drugs for Glioblastoma, Adult →
• Glioblastoma — all drugs for Glioblastoma →
• Recurrent Brain Tumor — all drugs for Recurrent Brain Tumor →

Sponsor

Amsterdam UMC, location VUmc — full company profile →

Who can join

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

Sponsor's own description

In this study the investigators will evaluate the effect of high-dose, intermittent sunitinib versus treatment with lomustine in patients with recurrent glioblastoma multiforme. The investigators hypothesize that sunitinib, when given in a high-dose, intermittent schedule, will achieve adequate concentration levels in the tumor and will, besides its anti-angiogenic properties, inhibit gliomagenesis by inhibition of multiple kinases.

Publications & conference data

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

1. 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
2. Recurrent Glioblastoma: From Molecular Landscape to New Treatment Perspectives.
   Birzu C, French P, Caccese M, Cerretti G, et al · · 2020 · cited 141× · PMID 33375286 · DOI 10.3390/cancers13010047
3. Advances in the Knowledge of the Molecular Biology of Glioblastoma and Its Impact in Patient Diagnosis, Stratification, and Treatment.
   Delgado-Martín B, Medina MÁ. · · 2020 · cited 129× · PMID 32382477 · DOI 10.1002/advs.201902971
4. Treatment options for progression or recurrence of glioblastoma: a network meta-analysis.
   McBain C, Lawrie TA, Rogozińska E, Kernohan A, et al · · 2021 · cited 105× · PMID 34559423 · DOI 10.1002/14651858.cd013579.pub2
5. A Systematic Review of Glioblastoma-Targeted Therapies in Phases II, III, IV Clinical Trials.
   Cruz Da Silva E, Mercier MC, Etienne-Selloum N, Dontenwill M, et al · · 2021 · cited 99× · PMID 33918704 · DOI 10.3390/cancers13081795
6. The theory of tumor ecosystem.
   Chen X, Song E. · · 2022 · cited 93× · PMID 35642770 · DOI 10.1002/cac2.12316
7. New Directions in the Therapy of Glioblastoma.
   Szklener K, Mazurek M, Wieteska M, Wacławska M, et al · · 2022 · cited 68× · PMID 36358795 · DOI 10.3390/cancers14215377
8. The Vascular Microenvironment in Glioblastoma: A Comprehensive Review.
   Mosteiro A, Pedrosa L, Ferrés A, Diao D, et al · · 2022 · cited 45× · PMID 35740307 · DOI 10.3390/biomedicines10061285