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

• Status: Completed
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aileron Therapeutics; Aileron Therapeutics, Inc.
• Treatments: Cytarabine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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