drugset / Trial / NCT05155709

A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Chemotherapy.

NCT05155709

Phase 1 Completed 14 enrolled Novartis Pharmaceuticals
Non-randomizedSingle-groupOpen-labelTreatment

Summary

A study of siremadlin in combination with venetoclax plus azacitidine in adult participants with AML who are ineligible for chemotherapy. The primary purpose of this study was to assess whether siremadlin in combination with venetoclax plus azacitidine can enhance the clinical response in unfit AML participants without unacceptable levels of treatment-emergent toxicities.

Timeline

Start
2022-05-17
Primary completion
2024-04-17
Completion
2024-04-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Siremadlin Small molecule 20 mg Oral
Background Azacitidine Other / unclassified 75 mg/m2 Intravenous
Background Venetoclax Small molecule 400 mg Oral