NCT04547855

Anlotinib Combined With Dose-dense Temozolomide for the First Recurrent or Progressive Glioblastoma After STUPP Regimen

Status unknown Phase 2 Last updated 14 September 2020

What this trial tests

Phase 2 trial testing anlotinib combined with dose-dense temozolomide in Glioblastoma in 54 participants. Status unknown.

Timeline

11 September 2020

Primary endpoint
11 September 2022

11 March 2023

Quick facts

Lead sponsor	Yonggao Mou
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	54
Start date	11 September 2020
Primary completion	11 September 2022
Estimated completion	11 March 2023
Sites	1 location across China

Drugs / interventions tested

• anlotinib combined with dose-dense temozolomide — full drug profile →

Conditions studied

• Glioblastoma — all drugs for Glioblastoma →

Sponsor

Yonggao Mou — full company profile →

Who can join

Adults 18 to 75, any sex, with Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Currently,6 cycles of Temozolomide adjuvant chemotherapy after concurrent radiotherapy and Temozolomide chemotherapy(STUPP regimen)for newly diagnosed postoperative GBM can increase the 2-year and 5-year overall survival rates of patients to 26.5% and 9.8%, respectively. However, most patients are still unable to avoid tumor recurrence and death.Anlotinib is an efficient multi-target tyrosine kinase inhibitor (TKI) that effectively block the migration and proliferation of endothelial cells and reduce tumor microvascular density by targeting VEGFRs, FGFRs, PDGFRs. It has been proved to be safe and effective in advanced lung cancer(including NSCLC,SCLC)after second-line standard chemotherapy failure,and advanced soft tissue sarcoma after anthracycline-containing chemotherapy failure.Here, we prepared to evaluate whether the combination of dose-dense Temozolomide and Anlotinib can preferably improved survival of the first recurrent or progressive GBM after STUPP regimen.

Publications & conference data

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

1. Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
   Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7
2. An update on the molecular biology of glioblastoma, with clinical implications and progress in its treatment.
   Verdugo E, Puerto I, Medina MÁ. · · 2022 · cited 152× · PMID 36129048 · DOI 10.1002/cac2.12361
3. Molecular targeted therapy: A new avenue in glioblastoma treatment.
   El Atat O, Naser R, Abdelkhalek M, Habib RA, et al · · 2023 · cited 24× · PMID 36644133 · DOI 10.3892/ol.2022.13632
4. Tyrosine Kinase Inhibitors in Adult Glioblastoma: An (Un)Closed Chapter?
   Aldaz P, Arozarena I. · · 2021 · cited 24× · PMID 34830952 · DOI 10.3390/cancers13225799
5. Novel Receptor Tyrosine Kinase Pathway Inhibitors for Targeted Radionuclide Therapy of Glioblastoma.
   Bolcaen J, Nair S, Driver CHS, Boshomane TMG, et al · · 2021 · cited 17× · PMID 34209513 · DOI 10.3390/ph14070626
6. Small Molecule Tyrosine Kinase Inhibitors (TKIs) for Glioblastoma Treatment.
   Frumento D, Grossi G, Falesiedi M, Musumeci F, et al · · 2024 · cited 16× · PMID 38338677 · DOI 10.3390/ijms25031398
7. FGFR3-TACCs3 Fusions and Their Clinical Relevance in Human Glioblastoma.
   Gött H, Uhl E. · · 2022 · cited 16× · PMID 35955806 · DOI 10.3390/ijms23158675
8. Glioblastoma, <i>IDH</i>-Wild Type With <i>FGFR3-TACC3</i> Fusion: When Morphology May Reliably Predict the Molecular Profile of a Tumor. A Case Report and Literature Review.
   Broggi G, Piombino E, Altieri R, Romano C, et al · · 2022 · cited 13× · PMID 35222252 · DOI 10.3389/fneur.2022.823015