Treatment of Patients With Recurrent High-Grade Glioma With APG-157 and Bevacizumab
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorAveta Biomics, Inc.
About this trial
The goal of this interventional study is to evaluate the efficacy of APG-157 in combination with Bevacizumab in subjects with recurrent high-grade glioma. The main questions the study aims to answer are:
* Progression-free and overall survival of patients receiving this combination; * Quality of Life (QOL); and * Tumor response on imaging
The participants will take APG-157 daily by dissolving two pastilles in their mouth at around breakfast, lunch and dinner time (total of six pastilles per day). The pastilles dissolve in the mouth.
The participants will continue to receive Bevacizumab as standard of care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must have pathologically proven diagnosis of high grade (aka grade III or IV) glioma that has progressed on bevacizumab (anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma, gliosarcoma, H3K27M mutant glioma).
Patients must have received prior radiation therapy and standard temozolomide. Patients who have received any number of therapies for previous progressions will be considered eligible.
Patients must be three or more months from the end of chemoradiotherapy or have biopsy or imaging consistent with disease progression.
Physiologic Status/Age: Patients must be 19 years of age or older (the age of consent in Nebraska.)
Disqualifiers
Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of oral APG-157, or put the study outcomes at undue risk
Immunotherapy, chemotherapy, radiotherapy, or experimental therapy within one full cycle period before first dose of study drug (i.e., for lomustine 6 weeks, for temozolomide 4 weeks)
Lactating or pregnant
History of uncontrollable allergic reactions to bevacizumab
Trial design
Design model
Single group
Treatments tested in this trial
APG-157
DrugThe participants will receive APG-157 daily; and continue to receive Bevacizumab as standard of care.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: APG-157Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-free Survival
To evaluate progression-free survival of participants with recurrent high-grade glioma treated with APG-157 and Bevacizumab. Progression of the disease will be assessed using commonly used imaging modality such as Magnetic Resonance Imaging or CT scan.
Time frame
From date of commencement of treatment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months2
Overall Survival
To evaluate overall survival of participants with recurrent high-grade glioma treated with APG-157 and Bevacizumab
Time frame
From date of commencement of treatment until the date of death from any cause. Duration of assessment will be 12 months from the date of commencement of the treatment.Secondary outcomes
1
QOL assessment (EORTC QLQ-C30)
Descriptively examine quality of life (QOL) using EORTC QLQ-C30 (Organization for Research and Treatment in Cancer Quality of Life Questionnaire C30). EORTC QLQ-C30 is a standardized questionnaire that rates function, symptoms and health status from patient perspective using various questions on a scale of 1 - 4 where generally 1 is rated as normal or no issue (not at all) and 4 being the maximum adverse impact being experienced (very much).
Time frame
Every 8 weeks; from date of commencement of treatment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months2
Radiographic studies MRI or CT of the brain
To measure tumor size in response to treatment
Time frame
Every 8 weeks; from date of commencement of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months3
Pharmacokinetics (PK) of APG-157
Measure the amount of APG-157 components in the blood in the presence of bevacizumab
Time frame
At three timepoints: at start of dosing; at end of cycle 1 (each cycle is 28 days); and at end of cycle 2 after start of dosing.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov