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Methyltransferase Inhibitor

ASTX727 for Brain Cancer

Phase 1
Recruiting
Led By Isabel Arrillaga-Romany
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have archived primary tumor biopsies or surgical specimens for additional exploratory translational studies
Female participants with reproductive potential must have a negative serum pregnancy test within 14 days prior to the first study drug administration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing if a higher dose of ASTX727 is safe for patients with a certain type of brain tumor.

Who is the study for?
Adults with recurrent/progressive non-enhancing IDH mutant gliomas who've completed radiation at least 12 weeks prior, understand the consent process, have good liver and kidney function, stable brain scans within 28 days of starting treatment, and a life expectancy over 6 months. Not for pregnant/breastfeeding individuals or those with certain medical conditions that could interfere with the trial.Check my eligibility
What is being tested?
The study is testing ASTX727 to find the highest safe dose for patients with specific types of brain tumors (non-enhancing IDH mutant gliomas). It involves people who've had previous treatments as well as those untreated. Some participants may need accessible tumors for surgical evaluation.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects of ASTX727 based on its class may include gastrointestinal issues like nausea or vomiting, fatigue, liver problems, and blood count abnormalities. Specific side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have saved samples from my initial cancer biopsy or surgery.
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I am a woman who can have children and have a recent negative pregnancy test.
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My bone marrow is functioning well.
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My low-grade brain tumor has grown or come back, shown by scans.
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I have not received any treatment for my brain tumor.
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I am 18 years old or older.
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My glioma has a confirmed IDH1 or IDH2 mutation.
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I am mostly able to take care of myself.
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My liver is working well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of randomization until disease progression or death, up to five years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of randomization until disease progression or death, up to five years 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
Secondary outcome measures
Median Progression Free Survival
Overall Survival
Response Rate

Side effects data

From 2019 Phase 1 & 2 trial • 130 Patients • NCT02103478
50%
Thrombocytopenia
47%
Nausea
43%
Dizziness
40%
Fatigue
40%
Neutropenia
40%
Constipation
37%
Leukopenia
33%
Arthralgia
30%
Diarrhea
30%
Asthenia
27%
Anemia
27%
Sepsis
27%
Vomiting
23%
Dyspnea
23%
Febrile neutropenia
23%
Pyrexia
23%
Headache
23%
Cough
23%
Decreased appetite
20%
Hypokalemia
20%
Hypoalbuminemia
20%
Abdominal pain upper
20%
Weight decreased
20%
Epistaxis
17%
Pneumonia
17%
Stomatitis
17%
Fall
17%
Hypomagnesemia
17%
Hyponatremia
17%
Pain in extremity
17%
Oropharyngeal pain
17%
Hypotension
13%
Myalgia
13%
Back pain
13%
Alanine aminotransferase increased
13%
Electrocardiogram QT prolonged
13%
Contusion
13%
Blood creatinine increased
13%
Blood bilirubin increased
13%
Insomnia
13%
Pruritus
10%
Edema peripheral
10%
Hypocalcemia
10%
Aspartate aminotransferase increased
10%
Hyperglycemia
10%
Dehydration
10%
Abdominal pain
10%
Chills
10%
Sinusitis
10%
Nasopharyngitis
10%
Hemoptysis
10%
Pulmonary edema
10%
Erythema
10%
Acute kidney injury
7%
Upper respiratory tract infection
7%
Influenza
7%
Bone pain
7%
Dyspepsia
7%
Syncope
7%
Conjunctival hemorrhage
7%
Hemorrhoids
7%
Proctalgia
7%
Dental caries
7%
Tooth infection
7%
Hyperkalemia
7%
Muscle spasms
7%
Confusional state
7%
Dyspnea exertional
7%
Productive cough
7%
Petechiae
7%
Decubitus ulcer
7%
Blood blister
7%
Hematoma
7%
Oral candidiasis
7%
Musculoskeletal pain
7%
Presyncope
7%
Septic shock
7%
Abdominal distension
7%
Laceration
7%
Delirium
7%
Hematuria
7%
Rash maculo-papular
7%
Cataract
3%
Respiratory failure
3%
Oral herpes
3%
Hypophosphatemia
3%
Failure to thrive
3%
Blood alkaline phosphatase increased
3%
Subdural hemorrhage
3%
Malena
3%
Deep vein thrombosis
3%
Gastrointestinal hemorrhage
3%
Multiple organ dysfunction syndrome
3%
Cardiac arrest
3%
Sudden death
3%
Cellulitis
3%
Small cell lung cancer
3%
Tachypnea
3%
Anal fissure
3%
Large intestine perforation
3%
Subdural hematoma
3%
Urinary tract infection
3%
Blood urea increased
3%
Hypernatremia
3%
Anxiety
3%
Nasal congestion
3%
Dry skin
3%
Blood lactate dehydrogenase increased
3%
Hyperuricemia
3%
Hyperhidrosis
3%
Peripheral ischemia
3%
Atypical pneumonia
3%
Oral pain
3%
Pollakiuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 Fixed-Dose Combination
Phase 2 Dose Confirmation
Phase 1 Dose Escalation Cohort 5
Phase 1 Dose Escalation Cohort 1
Phase 1 Dose Escalation Cohort 3
Phase 1 Dose Escalation Cohort 4
Phase 1 Dose Escalation Cohort 2

Trial Design

2Treatment groups
Experimental Treatment
Group I: Expansion CohortExperimental Treatment1 Intervention
Oral ASTX727 will be administered daily for 4, 5 or 6 consecutive days Surgical resection will take place 12 days (+/- 1 day) after initiation of treatment
Group II: ASTX727 (Cedazuridine + Cytidine Antimetabolite Decitabine)Experimental Treatment1 Intervention
-ASTX727 administered orally for 5 or 6 consecutive days every 28d cycle and will de-escalate to 4 consecutive days every 28 d cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ASTX727
2018
Completed Phase 3
~240

Find a Location

Who is running the clinical trial?

Astex Pharmaceuticals, Inc.Industry Sponsor
95 Previous Clinical Trials
7,943 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,943 Previous Clinical Trials
13,200,931 Total Patients Enrolled
Isabel Arrillaga-RomanyPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital, Massachusetts General Physicians Organization Inc
Tufts University School Of Medicine (Medical School)
1 Previous Clinical Trials
70 Total Patients Enrolled

Media Library

ASTX727 (Methyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03922555 — Phase 1
~0 spots leftby May 2024
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