NCT06737081

SAL-0951 in the Treatment of Chemotherapy-induced Anemia in Patients With Non-myeloid Malignancies

A Parallel, Open-label Phase II Clinical Study of Enarodustat (SAL-0951) Tablets in the Treatment of Chemotherapy-induced Anemia in Patients With Non-myeloid Malignancies

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of SAL-0951 in the treatment of chemotherapy-induced anemia (CIA) in patients with non-myeloid malignancies

Detailed description

This trial is a multicenter, randomized, open-label phase II clinical study exploring the starting dose, aiming to evaluate the safety and efficacy of Enarodustat Tablets in the treatment of chemotherapy-induced anemia (CIA) in patients with non-myeloid malignancies, so as to optimize the dose for phase III trials. It is planned to enroll approximately 60 patients. The trial consists of a screening period (4 weeks), an open-label treatment period (up to 16 weeks), and a follow-up period (2 weeks), totaling approximately 22 weeks. Subjects who withdraw early will be asked to complete an end of treatment visit, and a safety follow-up visit 2 weeks after the end of treatment visit.

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	SAL-0951 tablets 4mg	initial phase：4mg QD subsequent phase：1mg～8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks
DRUG	SAL-0951 tablets 5mg	initial phase：5mg QD subsequent phase：1mg～8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks

Timeline

• Start date: 2024-09-14
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2024-12-17
• Last updated: 2024-12-17

Locations

1 site across 1 country: China