NCT04638491

Safety Tolerability Pharmacokinetic and Preliminary Efficacy in Chinese Advanced Solid Tumors Patients

Phase 1, Single-arm, Open-label, Dose Escalating and Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of Lurbinectedin (PM01183) for Injection in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 1, single-arm, open-label, dose escalating and expansion clinical trial to evaluate the safety, tolerability, pharmacokinetic and preliminary efficacy of Lurbinectedin (PM01183) for injection in patients with advanced solid tumors

Detailed description

To evaluate the safety and tolerability of PM01183 as a single agent, and to identify the dose limiting toxicities (DLTs), determine the recommended dose (RD) in Chinese advanced solid tumors patients

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Lurbinectedin for injection	On the first day of each cycle, patients with advancedsolid tumors or small cell lung cancer were treated with Lurbinectedin for injection

Timeline

• Start date: 2020-11-24
• Primary completion: 2023-11-04
• Completion: 2023-11-04
• First posted: 2020-11-20
• Last updated: 2024-06-10

Locations

1 site across 1 country: China