Safety Study of ALRN-6924 in Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

Completed · Phase 1

Conditions studied: Acute Myeloid Leukemia, Myelodysplastic Syndromes

In brief

Phase 1/1b, open label, multi-center dose escalation and dose expansion study designed to evaluate safety, tolerability, PK (pharmacokinetics), PD (pharmacodynamics) and anti-tumor effects of ALRN-6924 alone or in combination with cytarabine in patients with relapsed/refractory acute myeloid leukemia or advanced myelodysplastic syndrome with wild-type (WT) TP53

Key facts

Study ID

NCT02909972

Run by

Aileron Therapeutics, Inc.

People needed

55

Starts

2016-09-01

Expected to finish

2019-08-01

Last updated by the study team

2019-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Relapsed or refractory acute myeloid leukemia or IPSS-R intermediate/high/very high-risk MDS patients
• Confirmed or anticipated wild-type TP53
• ECOG (Eastern Cooperative Oncology Group) performance status 0-2
• Adequate hepatic and renal function
• Acceptable coagulation function
• Negative serum or urine pregnancy test within 7 days prior to the first dose of ALRN-6924 for women of child-bearing potential
• Sufficient wash out from prior therapies and recovery from all significant toxicities

You may not qualify if…

• Patients are eligible for available approved standard therapies
• Prior treatment with MDM2 inhibitor, with protocol specified exceptions
• Patients with history of allogeneic stem cell transplantation
• Leukemic blast counts of >25,000/µl
• Deletion of chromosome 17, or del(17p)
• Patients with evidence of current central nervous system leukemic involvement
• Known hypersensitivity to any study drug component
• History of coagulopathy
• Prior specified cardiovascular risk factors
• Clinically significant gastrointestinal bleeding within 6 months
• Clinically significant third-space fluid accumulation
• Pregnant or lactating females
• Evidence of any serious and/or unstable pre-existing medical condition that would interfere with patient safety ability to provide informed consent
• Active uncontrolled infection, including HIV/AIDS or Hepatitis B or C
• Second malignancy within one year, with protocol specified exceptions

Where it is running

• Study site — Denver, Colorado, United States
• Study site — Tampa, Florida, United States
• Study site — The Bronx, New York, United States
• Study site — Portland, Oregon, United States
• Study site — Greenville, South Carolina, United States
• Study site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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