NCT03008148

Randomized Phase II/III Trial of Radiotherapy Plus Concomitant and Adjuvant Temozolomide With or Without Hydroxychloroquine, Rapamycin for Newly Diagnosed Glioblastoma

Status unknown Phase 2/Phase 3 Last updated 10 May 2021

What this trial tests

Phase 2/Phase 3 trial testing CCRT in Glioblastoma in 288 participants. Status unknown.

Timeline

11 October 2018

Primary endpoint
1 April 2025

1 April 2025

Quick facts

Lead sponsor	Johnpro Biotech, Inc.
Phase	Phase 2/Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	288
Start date	11 October 2018
Primary completion	1 April 2025
Estimated completion	1 April 2025
Sites	2 locations across Taiwan

Drugs / interventions tested

• CCRT
• Temozolomide (temozolomide) — full drug profile →
• Siroquine — full drug profile →

Conditions studied

• Glioblastoma — all drugs for Glioblastoma →

Sponsor

Johnpro Biotech, Inc. — full company profile →

Who can join

Adults 20 to 80, any sex, with Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Overall survival time.
  Time frame: 120 weeks
  All subjects will be followed until study end (the date of last subject last visit; the last subject need to be followed at least 30 months) or death, whichever comes first; OS defined as the time from the date of Randomization to the date of death or last follow-up.

Sponsor's own description

This is a multi-center, phase II/III, open-label, randomized, parallel and standard chemoradiation-controlled study where eligible subjects will be randomized at 1:1 ratio to receive control treatment or study treatment. The primary objective of this trial is to evaluate the effect of add-on JP001 to standard chemoradiation in increasing overall survival (OS) on newly diagnosed glioblastoma (GBM) patients.

Publications & conference data

7 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. Chloroquine against malaria, cancers and viral diseases.
   Zhou W, Wang H, Yang Y, Chen ZS, et al · · 2020 · cited 85× · PMID 32947043 · DOI 10.1016/j.drudis.2020.09.010
3. Crosstalk between autophagy inhibitors and endosome-related secretory pathways: a challenge for autophagy-based treatment of solid cancers.
   Raudenska M, Balvan J, Masarik M. · · 2021 · cited 65× · PMID 34706732 · DOI 10.1186/s12943-021-01423-6
4. Regulation of Apoptosis by Autophagy to Enhance Cancer Therapy.
   Tompkins KD, Thorburn A. · · 2019 · cited 51× · PMID 31866785
5. Autophagy Regulation on Cancer Stem Cell Maintenance, Metastasis, and Therapy Resistance.
   Wang X, Lee J, Xie C. · · 2022 · cited 38× · PMID 35053542 · DOI 10.3390/cancers14020381
6. Autophagy and cancer therapy.
   Pimentel JM, Zhou JY, Wu GS. · · 2024 · cited 27× · PMID 39395780 · DOI 10.1016/j.canlet.2024.217285
7. Recent developments in autophagy-targeted therapies in cancer.
   Jogalekar MP, Veerabathini A, Gangadaran P. · · 2021 · cited 15× · PMID 33167689 · DOI 10.1177/1535370220966545