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ERK Inhibitor

Decitabine + Cedazuridine + ERK Inhibitor for Myelodysplastic Syndromes

Phase 1 & 2

Waitlist Available

Led By Guillermo Montalban Bravo

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HBV viral load undetectable on suppressive therapy for chronic HBV infection

ECOG Performance Status 0-2

Must not have

Active, life-threatening, or clinically-significant uncontrolled systemic infection requiring hospitalization

History of HIV with specific CD4+ T-cell counts or AIDS-defining opportunistic infections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine the highest safe dose of ASTX029 that can be given with ASTX727 to patients with specific types of blood disorders. The second part of the study will investigate if this

Who is the study for?

This trial is for patients with certain blood disorders, specifically RAS-mutant Myelodysplastic Syndromes (MDS) or MDS/Myeloproliferative Neoplasms (MPN). Participants should be able to tolerate the treatments and meet specific health criteria not detailed here.

What is being tested?

The study is testing a combination of two drugs: ASTX029, an ERK inhibitor, and ASTX727. The first part aims to find the highest dose of ASTX029 that's safe when combined with ASTX727; the second part tests if this dose can control the disease.

What are the potential side effects?

While specific side effects are not listed here, typical reactions may include fatigue, nausea, skin rash or itching due to drug sensitivity. Side effects vary based on individual tolerance and dosage received.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My hepatitis B virus levels are undetectable with current treatment.

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I can take care of myself and perform daily activities.

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My liver tests are within the required range.

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I had hepatitis C but have been treated and cured.

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I am 18 years old or older.

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I have been diagnosed with MDS or MDS/MPN.

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My cancer has a mutation in a gene related to the RAS pathway.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a severe infection that required hospitalization.

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I have HIV with specific immune cell counts or serious infections.

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I am currently being treated for cancer.

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I have a condition that affects how my body absorbs medication.

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I do not have severe heart issues like heart failure or a long QTc interval.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and adverse events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohorts B and C: Combination of ASTX727 + ASTX029Experimental Treatment2 Interventions

Participants will take ASTX029 daily on days 1-21 of each 28-day cycle. ASTX727 daily on days 1-5 of each 28-day cycle. Both ASTX029 and ASTX727 should be taken with water on an empty stomach, no food 2 hours before and 2 hours after dose.

Group II: Cohort A: Single agent ASTX029Experimental Treatment1 Intervention

Participants will take ASTX029 daily on days 1-21 of each 28-day cycle. ASTX029 should be taken with water on an empty stomach, no food 2 hours before and 2 hours after dose.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ASTX727

2018

Completed Phase 3

~270

ASTX029

2020

Completed Phase 1

~20