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Small Molecule Inhibitor
PRT543 for Chronic Myelomonocytic Leukemia
Phase 1
Waitlist Available
Research Sponsored by Prelude Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Metastatic or advanced solid tumor; or advanced diffuse large B-cell lymphoma; or advanced mantle cell lymphoma; or relapsed myelodysplastic syndrome, acute myeloid leukemia or chronic myelomonocytic leukemia; or relapsed myelofibrosis. All malignancies must be refractory to established therapies
Biomarker-selected solid tumors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through approximately 2 years
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it is safe and what the best dose is.
Eligible Conditions
- Solid Tumors
- Chronic Myelomonocytic Leukemia
- Acute Myeloid Leukemia
- Adenoid Cystic Carcinoma
- Myelofibrosis
- Mantle Cell Lymphoma
- Myelodysplasia
- B-Cell Lymphoma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through approximately 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To describe dose limiting toxicities (DLT) of PRT543
To determine the maximally tolerated dose (MTD)
To determine the recommended phase 2 dose (RP2D) and schedule of PRT543
Secondary outcome measures
To describe the adverse event profile and tolerability of PRT543
To determine the maximum observed plasma concentration (Cmax) of PRT543
To determine the time to reach maximum observed plasma concentration (Tmax) of PRT543
Other outcome measures
To determine the area under the plasma concentration versus time curve (AUC) of PRT543
To determine the terminal elimination half-life (t1/2) of PRT543.
Trial Design
1Treatment groups
Experimental Treatment
Group I: PRT543Experimental Treatment1 Intervention
PRT543 will be administered orally
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PRT543
2019
Completed Phase 1
~240
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Who is running the clinical trial?
Prelude TherapeuticsLead Sponsor
8 Previous Clinical Trials
423 Total Patients Enrolled
Frequently Asked Questions
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