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New treatment option for Glioma
Official title Treatment of Patients With Recurrent High-Grade Glioma With APG-157 and Bevacizumab
ClinicalTrials.gov ID: NCT06011109
What this study is testing
What is APG-157?
APG-157 is an investigational medicine, given as an once-daily, being studied as a potential treatment for glioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Patients must have pathologically proven diagnosis of high grade (aka grade III or IV) glioma that has progressed on bevacizumab (anaplastic...
- Patients must have received prior radiation therapy and standard temozolomide. Patients who have received any number of therapies for previous...
- 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.)
- Patients must have recovered from any toxicity of prior therapy to Grade 1 or less.
You likely can't join if
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's...
- Immunotherapy, chemotherapy, radiotherapy, or experimental therapy within one full cycle period before first dose of study drug (i.e., for lomustine...
- Lactating or pregnant
- History of uncontrollable allergic reactions to bevacizumab
- Clinically Significant Cardiovascular Disease Defined as follows:
- Inadequately controlled hypertension (i.e., systolic blood pressure (SBP) \> 160 mm Hg and/or diastolic blood pressure (DBP) \> 90 mm Hg despite...
See the full eligibility criteria
- 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...
- 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.)
- Patients must have recovered from any toxicity of prior therapy to Grade 1 or less.
- ECOG Performance Status of 0-3.
- Patients must have an adequate bone marrow reserve (ANC count ≥1,500/mm3, hemoglobin \> 8 g/dL, platelet count ≥100,000/mm3).
- Patients must have adequate renal and hepatic function with:
- creatinine \< 1.5 x institutional upper limit of normal (ULN).
- total bilirubin \< 1.5 x ULN (unless due to Gilbert's disease)
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \<2.5 x ULN
- serum alkaline phosphatase less than 2.5 times the upper limits of normal)
- The patient must willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and...
- Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment.
- Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study. (Non-child bearing potential is defined as age 55 years or older and no menses for two years or any age with...
- 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...
- 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
- Clinically Significant Cardiovascular Disease Defined as follows:
- Inadequately controlled hypertension (i.e., systolic blood pressure (SBP) \> 160 mm Hg and/or diastolic blood pressure (DBP) \> 90 mm Hg despite antihypertensive therapy)
- History of cerebrovascular accident (CVA) within 6 months
- Myocardial infarction or unstable angina within 6 months
- Evidence or history of bleeding diathesis (greater than normal risk of bleeding, i.e., Hereditary Hemorrhagic Telangiectasia type I or HHT-1) or coagulopathy in the absence of therapeutic anti-coagulation or any...
- Active wound, a serious or non-healing wound, an active ulcer or untreated bone fracture within the last two months.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess ≤ 6 months prior to registration.
- Major surgical procedure, open biopsy, or significant traumatic injury ≤ 28 days prior to registration
- Any other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give...
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
- Omaha, Nebraska, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States; Omaha, Nebraska, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.