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

NCT04638491 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-06-10

No results posted yet for this study

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

Conditions

  • Advanced Solid Tumor

Interventions

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

Sponsors & Collaborators

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Principal Investigators

  • cheng ying, Doctor · Jilin Provincial Tumor Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-24
Primary Completion
2023-11-04
Completion
2023-11-04

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04638491 on ClinicalTrials.gov