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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of randomization until disease progression or death, up to five years

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

56%

Neutropenia

54%

Thrombocytopenia

46%

Fatigue

38%

Diarrhea

34%

Febrile neutropenia

34%

Constipation

32%

Anemia

28%

Dizziness

26%

Edema peripheral

26%

Nausea

24%

Arthralgia

24%

Dyspnea

24%

Leukopenia

24%

Hypomagnesemia

24%

Cough

22%

Back pain

22%

Alanine aminotransferase increased

20%

Hypoalbuminemia

20%

Hypocalcemia

18%

Aspartate aminotransferase increased

18%

Cellulitis

16%

Blood creatinine increased

16%

Pneumonia

16%

Decreased appetite

14%

Pyrexia

14%

Asthenia

14%

Weight decreased

14%

Contusion

14%

Hyperkalemia

14%

Anxiety

12%

Epistaxis

12%

Blood alkaline phosphatase increased

12%

Hyperglycemia

12%

Mouth ulceration

12%

Fall

12%

Hyponatremia

12%

Myalgia

12%

Headache

12%

Insomnia

12%

Oropharyngeal pain

12%

Oral pain

12%

Upper respiratory tract infection

10%

Hypokalemia

10%

Sepsis

10%

Blood bilirubin increased

10%

Dyspnea exertional

10%

Hypertension

Stomatitis

Urinary tract infection

Hypernatremia

Pain in extremity

Blood lactate dehydrogenase increased

Upper airway cough syndrome

Laceration

Rash maculo-papular

Paresthesia

Hypophosphatemia

Chills

Oral herpes

Bacteremia

Abdominal pain

Vomiting

Pain

Blood urea increased

Hypoasthesia

Nasal congestion

Petechiae

Dry skin

Deep vein thrombosis

Palpitations

Hyperuricemia

Hyperhidrosis

Pollakiuria

Toothache

Dehydration

Gastrointestinal hemorrhage

Hemorrhoids

Abdominal distension

Proctalgia

Sinusitis

Nasopharyngitis

Muscle spasms

Pulmonary edema

Erythema

Hypotension

Hematoma

Oral candidiasis

Musculoskeletal pain

Acute kidney injury

Hematuria

Pancreatitis

Pyomyositis

Failure to thrive

Bone pain

Gout

Presyncope

Neck pain

Mental status change

Pharyngitis

Bursitis

Respiratory failure

Cardiogenic shock

Influenza

Bacterial infection

Endocarditis

Escherichia infection

Joint stiffness

Cerebrovascular accident

Seizure

Acute febrile neutrophilic dermatosis

Anal abscess

Soft tissue infection

Oral infection

Squamous cell carcinoma of the tongue

Abdominal pain upper

Dental caries

Electrocardiogram QT prolonged

Productive cough

Pruritus

Decubitus ulcer

Blood blister

Myocarditis

Sinus tachycardia

Hypersensitivity

Subcutaneous abscess

Musculoskeletal stiffness

100%

80%

60%

40%

20%

Study treatment Arm

Phase 2 Dose Confirmation

Phase 2 Fixed-Dose Combination

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

0 / 9Eligibility criteria met

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

2,933 Previous Clinical Trials

13,198,473 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

Frequently Asked Questions

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

What assessments have been conducted to determine the safety of ASTX727 for patients?

"The safety of ASTX727 was estimated to be a 1 due to the Phase 1 nature of this trial, meaning there is limited evidence in support both its efficacy and security."

Answered by AI

Does this research endeavor currently have open enrollment slots?

"As per data sourced from clinicaltrials.gov, the current status of this medical trail is recruiting patients. The trial was initially posted on July 12th 2019 and had its most recent review on September 5th 2020."

Answered by AI

How many individuals are enrolled in the current clinical experiment?

"Affirmative. Clinicaltrials.gov conveys that this research study, which was initially advertised on July 12th 2019, is recruiting participants at the moment. Approximately 18 individuals must be recruited from 3 different medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ASTX727 in Recurrent/Progressive Non-enhancing IDH Mutant Gliomas

Isabel Arrillaga-Romany 2019. "ASTX727 in Recurrent/Progressive Non-enhancing IDH Mutant Gliomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03922555.