NCT03125876

A Phase Ib Study of CT053PTSA in Relapsed / Refractory Acute Myeloid Leukemia (AML)

A Phase Ib, Multi-center, Open, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Ningetinib (CT053PTSA) in Relapsed / Refractory Acute Myeloid Leukemia (AML)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of CT053PTSA in Relapsed/refractory AML patients with FLT3 gene mutation.

Detailed description

It is a multi-center , open-label, dose escalation study conducted in 2 parts. Dose-escalation part: Subjects will receive oral CT053PTSA once daily repeatedly until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days. At least 3 subjects will receive CT053PTSA at each dose (60, 80, 100mg) for determination of Maximum Tolerated Dose(MTD) and Dose Limiting Toxicity (DLT) Dose reduction of CT053PTSA will be considered if study drug-related toxicities are observed in a subject after Cycle 1. Expansion part:Expansion cohort might be set to further investigate the safety and efficacy of CT053PTSA at or lower MTD dose recommended by dose-escalation part.

Conditions

• Acute Myeloid Leukemia (AML)

Interventions

Type	Name	Description
DRUG	CT053PTSA	receive oral CT053PTSA once daily until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days

Timeline

• Start date: 2017-11-13
• Primary completion: 2019-08-19
• Completion: 2019-08-19
• First posted: 2017-04-24
• Last updated: 2021-03-24

Locations

1 site across 1 country: China