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Anti-metabolites

ASTX727 for Peripheral Nerve Sheath Tumor

Phase 2
Recruiting
Led By Ping Chi, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be at least 18 years of age
Patients must have advanced, unresectable or metastatic MPNSTs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of 16 weeks
Awards & highlights

Study Summary

This trial is testing whether ASTX727 is an effective treatment for people who have MPNST with a PCR2 mutation.

Who is the study for?
This trial is for adults with malignant peripheral nerve sheath tumors (MPNST) that have a specific mutation called PCR2. Participants must have tried at least one standard treatment or be unsuitable for chemotherapy, and their cancer should be advanced and measurable. They need to be in fair health overall, able to take pills, not pregnant or breastfeeding, willing to use contraception, and without certain heart conditions or recent major surgeries.Check my eligibility
What is being tested?
ASTX727 is being tested as a potential treatment for MPNST with PCR2 mutation. It's a combo of cedazuridine and decitabine designed to target cancer cells more effectively than decitabine alone by disrupting the tumor cells' survival mechanisms.See study design
What are the potential side effects?
While the exact side effects are not listed here, ASTX727 includes decitabine which can cause low blood cell counts leading to increased infection risk, bleeding issues, fatigue; gastrointestinal symptoms like nausea; liver function changes; and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer cannot be removed by surgery and has spread.
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I can take care of myself but might not be able to do heavy physical work.
Select...
My tumor is confirmed to lack PRC2.
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I can take pills by mouth.
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My cancer has worsened after treatment, or chemotherapy isn't right for me.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
the best clinical benefit rate (CBR)
Secondary outcome measures
objective response rate (ORR)

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
8%
Stomatitis
8%
Urinary tract infection
8%
Hypernatremia
8%
Pain in extremity
8%
Blood lactate dehydrogenase increased
8%
Upper airway cough syndrome
8%
Laceration
8%
Rash maculo-papular
6%
Paresthesia
6%
Hypophosphatemia
6%
Chills
6%
Oral herpes
6%
Bacteremia
6%
Abdominal pain
6%
Vomiting
6%
Pain
6%
Blood urea increased
6%
Hypoasthesia
6%
Nasal congestion
6%
Petechiae
6%
Dry skin
6%
Deep vein thrombosis
6%
Palpitations
6%
Hyperuricemia
6%
Hyperhidrosis
6%
Pollakiuria
6%
Toothache
4%
Dehydration
4%
Gastrointestinal hemorrhage
4%
Hemorrhoids
4%
Abdominal distension
4%
Proctalgia
4%
Sinusitis
4%
Nasopharyngitis
4%
Muscle spasms
4%
Pulmonary edema
4%
Erythema
4%
Hypotension
4%
Hematoma
4%
Oral candidiasis
4%
Musculoskeletal pain
4%
Acute kidney injury
4%
Hematuria
2%
Pancreatitis
2%
Pyomyositis
2%
Failure to thrive
2%
Bone pain
2%
Gout
2%
Presyncope
2%
Neck pain
2%
Mental status change
2%
Pharyngitis
2%
Bursitis
2%
Respiratory failure
2%
Cardiogenic shock
2%
Influenza
2%
Bacterial infection
2%
Endocarditis
2%
Escherichia infection
2%
Joint stiffness
2%
Cerebrovascular accident
2%
Seizure
2%
Acute febrile neutrophilic dermatosis
2%
Anal abscess
2%
Soft tissue infection
2%
Oral infection
2%
Squamous cell carcinoma of the tongue
2%
Abdominal pain upper
2%
Dental caries
2%
Electrocardiogram QT prolonged
2%
Productive cough
2%
Pruritus
2%
Decubitus ulcer
2%
Blood blister
2%
Myocarditis
2%
Sinus tachycardia
2%
Hypersensitivity
2%
Subcutaneous abscess
2%
Musculoskeletal stiffness
100%
80%
60%
40%
20%
0%
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

1Treatment groups
Experimental Treatment
Group I: ASTX727 (cedazuridine and decitabine)Experimental Treatment1 Intervention
Patients who meet the eligibility criteria will be treated with oral ASTX727 (INQOVI) on days 1-5 of each 21-day cycle with Pegfilgrastim support on day 7. A delay in the start of subsequent cycles due to holidays, weather, or other circumstances will be permitted up to 7 days and not considered a protocol deviation. Drug dosing will be interrupted for any Grade 4 adverse events or clinically significant laboratory abnormalities. For Grade 3 or 4 AE, if the AE returns to Grade 1 or baseline, the patient may be re-escalated.
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?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,901 Total Patients Enrolled
Astex Pharmaceuticals, Inc.Industry Sponsor
95 Previous Clinical Trials
7,936 Total Patients Enrolled
Ping Chi, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
78 Total Patients Enrolled

Media Library

ASTX727 (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04872543 — Phase 2
Peripheral Nerve Sheath Tumor Research Study Groups: ASTX727 (cedazuridine and decitabine)
Peripheral Nerve Sheath Tumor Clinical Trial 2023: ASTX727 Highlights & Side Effects. Trial Name: NCT04872543 — Phase 2
ASTX727 (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04872543 — Phase 2

Frequently Asked Questions

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

Which venues are currently offering access to this trial?

"Eligible participants can join this medical trial at seven different institutions, such as the Memorial Sloan Kettering Nassau (Limited Protocol Activities) in Uniondale, and the Memorial Sloan Kettering Bergen (Limited Protocol Activities) in Montvale. The other four locations are available for consideration too."

Answered by AI

Are subjects being admitted to this clinical experiment presently?

"As per clinicaltrials.gov, this medical research is currently seeking to enrol participants. The trial was first made available on the 29th April 2021 and has been updated as recently as 25th August 2022."

Answered by AI

To what extent is the participant capacity for this research endeavor?

"Yes, the clinicaltrial.gov website affirms that this investigation is actively searching for patients; it was initially posted on April 29th 2021 and its most recent update occured on August 25th 2022. The trial aims to admit 25 individuals from 7 distinct medical sites."

Answered by AI

What hazards have been associated with ASTX727 consumption?

"Due to the lack of any efficacy data, ASTX727 only received a safety rating of 2 on our scale. However, there is some prior clinical evidence that suggests it may be relatively safe for human consumption."

Answered by AI

What former assessments have been conducted with respect to ASTX727?

"ASTX727 has a long history of medical study, having first been investigated during 2004 at Central Illinois Hematology Oncology Center. Currently, 117 trials have concluded and 104 remain active with many occurring in Uniondale, New york."

Answered by AI

For what indications is ASTX727 typically prescribed?

"ASTX727 is usually prescribed for individuals in the intermediate-2 risk category of ipss. It may also be helpful to those with high risk, refractory anemias, or other forms of anemia."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of ASTX727 in People With Malignant Peripheral Nerve Sheath Tumors (MPNST)
2021. "A Study of ASTX727 in People With Malignant Peripheral Nerve Sheath Tumors (MPNST)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04872543.
~10 spots leftby Apr 2026
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