NCT04017546

CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory AML or MDS

A Phase I Combination Study of CYC065 and Venetoclax in Patients with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Cyclacel Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory AML or MDS

Detailed description

This is an open-label, single arm, dose escalation study in patients with relapsed or refractory AML or MDS. Treatment will be administered on an outpatient basis and all patients will receive CYC065 over 4-hour infusion once every 2 weeks on Day 1 and Day 15 in combination with venetoclax. One treatment cycle is 4 weeks.

Conditions

• AML
• MDS

Interventions

Type	Name	Description
DRUG	CYC065	intravenous infusion
DRUG	Venetoclax	oral capsule

Timeline

• Start date: 2019-08-02
• Primary completion: 2022-11-15
• Completion: 2023-04-05
• First posted: 2019-07-12
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study