Clinical Trials Logo
  1. Home
  2. Acute Myeloid Leukemia (AML)
  3. NCT03125876

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

Acute Myeloid Leukemia (AML) Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03125876
Study type Interventional
Source Sunshine Lake Pharma Co., Ltd.
Contact
Status Terminated
Phase Phase 1
Start date November 13, 2017
Completion date August 19, 2019
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04240002 - A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML) Phase 1/Phase 2
Completed NCT02626715 - Reduced-Intensity Conditioning (RIC) and Myeloablative Conditioning (MAC) for HSCT in AML/MDS Phase 2
Completed NCT05488613 - Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML)
Completed NCT02265731 - Study Evaluating Venetoclax in Subjects With Hematological Malignancies Phase 1/Phase 2
Terminated NCT02927938 - Leukemia Stem Cell Detection in Acute Myeloid Leukemia Phase 3
Completed NCT01772953 - Treosulfan/Fludarabine/Low Dose TBI as a Preparative Regimen for Children With AML/MDS Undergoing Allo HCT Phase 2
Recruiting NCT03188874 - Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)
Completed NCT00071006 - AG-013736 (Axitinib) In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS) Phase 2
Completed NCT04079296 - A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS) Phase 1/Phase 2
Completed NCT04509622 - A Study of Oral Venetoclax Tablet in Combination With Subcutaneous Low-Dose Cytarabine (LDAC) Injection to Assess Adverse Events in Adult Japanese Participants With Acute Myeloid Leukemia (AML) Phase 3
Withdrawn NCT03699384 - Safety and Clinical Activity Study of Combination Azacitidine and Avelumab in Patients With Acute Myeloid Leukemia (AML) and Minimal Residual Disease (MRD) Phase 1/Phase 2
Recruiting NCT03613532 - Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN Phase 1
Completed NCT02252107 - 10-day Decitabine, Fludarabine and 2 Gray TBI as Conditioning Strategy for Poor and Very Poor Risk AML in CR1 Phase 2
Terminated NCT02259348 - Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation Phase 2
Terminated NCT01463410 - Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler N/A
Completed NCT01242774 - Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML) Phase 1
Terminated NCT02134782 - Yoga Fatigue Study N/A
Completed NCT01685619 - AML-MDS Novel Prognostic Tests Clinical Study
Completed NCT03625505 - A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia Phase 1
Active, not recruiting NCT04266795 - A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy Phase 2