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MDM2 Inhibitor

APG-115 + Azacitidine for Acute Myeloid Leukemia

Phase 1 & 2
Recruiting
Research Sponsored by Ascentage Pharma Group Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate organ function including liver function (total bilirubin ≤ 1.5 x upper limit of normal, AST and/or ALT < 3 x ULN), kidney function (calculated creatinine clearance ≥ 60 mL/min), known cardiac ejection fraction of ≥ 45% within the past 3 months, ECOG performance status of ≤ 2
Patients with a diagnosis of histologically confirmed relapsed or refractory AML, CMML, or high-risk MDS by World Health Organization (WHO) classification
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial is testing a new drug, APG-115, to see if it is safe and effective in treating patients with relapsed or refractory leukemia.

Who is the study for?
This trial is for adults with relapsed or refractory acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), or high-risk myelodysplastic syndrome (MDS). Participants must have a life expectancy of at least 12 weeks, adequate organ function, an ECOG performance status of ≤2, and no severe allergies to the treatments. Pregnant women and those not using contraception are excluded.Check my eligibility
What is being tested?
The study examines APG-115 alone or combined with Azacitidine in patients with certain blood cancers. Initially, it will assess the safety of APG-115 as a single agent; then it will test the combination therapy's effectiveness against these diseases.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to medication components, issues from uncontrolled infections like hepatitis B/C or HIV, heart problems such as congestive heart failure or arrhythmias, and complications related to recent stem cell transplants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My liver, kidneys, and heart are functioning well, and I can care for myself.
Select...
My condition is a type of blood cancer that has come back or didn’t respond to treatment.
Select...
No standard treatments are expected to work long-term for my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose

Trial Design

2Treatment groups
Experimental Treatment
Group I: APG-115 monotherapyExperimental Treatment1 Intervention
Monotherapy given in part 1
Group II: APG-115 + 5-azacitidine combinationExperimental Treatment2 Interventions
Combination therapy given in part 2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
APG-115
2016
Completed Phase 1
~50
5-azacitidine
2008
N/A
~30

Find a Location

Who is running the clinical trial?

Ascentage Pharma Group Inc.Lead Sponsor
46 Previous Clinical Trials
4,265 Total Patients Enrolled
Yifan Zhai, MD, PhDStudy ChairAscentage Pharma Group Inc.
18 Previous Clinical Trials
1,237 Total Patients Enrolled

Media Library

APG-115 (MDM2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04358393 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many centers are actively managing this research initiative?

"This medical trial is being conducted across 9 locations, such as the Duke University in Durham and the Texas Oncology - Baylor Charles A. Sammons Cancer Center located in Dallas, TX. There are also other sites like Banner MD Anderson Cancer Centre based in Gilbert."

Answered by AI

Is enrollment in this experiment open to the public?

"Indeed, the details posted on clinicaltrials.gov verify that this investigation is actively recruiting participants. This study was initially publicised on December 4th 2020 and amended most recently on July 8th 2022; it requires 69 test subjects from 9 medical centres."

Answered by AI

Are there any precedent studies that have used APG-115?

"APG-115 was first researched in 2006 at the Chinese University of Hong Kong-Prince of Wales Hospital. So far, 161 clinical trials have been completed and 174 are currently ongoing with a significant portion occurring in Durham, North carolina."

Answered by AI

What is the current enrollment rate of this clinical trial?

"To fulfil the requirements of this research project, 69 participants that meet set inclusion criteria must be recruited. Patients have access to trial sites such as Duke University in Durham and Texas Oncology - Baylor Charles A. Sammons Cancer Center in Dallas for their participation."

Answered by AI

What maladies are typically addressed by the administration of APG-115?

"APG-115 is generally prescribed for malignant neoplasms, but has also been validated to treat 20-30% blasts, neutropenia and/or thrombocytopenia, anemia."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of APG-115 Alone or Combined With Azacitidine in Patients With AML, CMML, or MDS
2020. "A Study of APG-115 Alone or Combined With Azacitidine in Patients With AML, CMML, or MDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04358393.
All > Mds > Myelodysplastic Syndrome
~11 spots leftby Dec 2024
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