Dose-Escalation Study of Oral Administration of LP-108 as Monotherapy and in Combination With Azacitidine in Patients With Relapsed or Refractory MDS, CMML, or AML

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

July 6, 2020

Primary Completion Date

January 31, 2025

Study Completion Date

January 31, 2025

Conditions
AML/MDSCMMLRelapseRefractory Acute Lymphoblastic LeukemiaRelapse LeukemiaRelapsed Adult AML
Interventions
DRUG

LP-108

For the dose escalation phase, LP-108 will be given once daily at the following dose levels: 100 mg QD, 200 mg QD, 400 mg QD, 600 mg QD, 800 mg QD, 1000 mg QD.

DRUG

LP-108 and azacitidine

For the dose escalation phase, LP-108 will be given once daily at the following dose levels: 100 mg QD, 200 mg QD, 400 mg QD, 600 mg QD, 800 mg QD, 1000 mg QD, with azacitidine at the standard dose of 75 mg/m2 on Day 1 - Day 7 of each 28-day cycle (weekly schedule) or on Days 1-5, 8, 9 of each 28-day cycle (5-2-2 schedule), according to institutional guidelines.

Trial Locations (7)

10003

Hospital San Pedro de Alcántara, Cáceres

43210

Ohio State Comprehensive Cancer Center, Columbus

45221

University of Cincinnati, Cincinnati

48109

University of Michigan, Ann Arbor

77030

MD Anderson Cancer Center, Houston

08916

Institut Català d'oncologia - ICO Badalona, Badalona

CP 46026

Instituto de Investigación Sanitaria La Fe, Valencia

Sponsors
All Listed Sponsors
lead

Newave Pharmaceutical Inc

INDUSTRY

NCT04139434 - Dose-Escalation Study of Oral Administration of LP-108 as Monotherapy and in Combination With Azacitidine in Patients With Relapsed or Refractory MDS, CMML, or AML | Biotech Hunter | Biotech Hunter