A Phase 1/1b Open-Label Study to Determine the Safety and Tolerability of ALRN-6924 Alone and in Combination With Cytarabine (Ara-C) in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome With Wild-Type TP53

NCT02909972 Phase 1 COMPLETED

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

Details

Lead sponsor	Aileron Therapeutics, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	55
Start date	2016-09
Completion	2019-08

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes

Interventions

• ALRN-6924
• ALRN-6924 in combination with cytarabine

Primary outcomes

• Evaluate the safety and tolerability of ALRN-6924 alone and in combination with cytarabine — From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle is 28 days)
  Number of participants with treatment-related adverse events as assessed by CTCAE v.4.0
• Determine maximum tolerated dose (MTD) — From the first dose until the end of Cycle 2 (each cycle is 28 days)
  Determine the dose limiting toxicities (DLT) and the maximum tolerated dose (MTD) or the optimal biological dose (OBD) of ALRN-6924 in adult patients with AML or MDS

Countries

United States