Study to Evaluate the Safety of Nanoxel M Inj.

• Conditions: Prostate Cancer; Ovarian Cancer; Gastric Cancer; Esophageal Cancer; Breast Cancer; Head and Neck Cancer; Non-small Cell Lung Cancer

• Registration Number: NCT04066335
• Lead Sponsor: Samyang Biopharmaceuticals Corporation

Brief Summary

Study to evaluate the safety of Nanoxel M inj. administration in patients.

Detailed Description

This is a multi-center, prospective observational study to observe the incidence of adverse events under actual clinical settings to test the safety of Nanoxel-M inj. administration in patients with breast cancer, non-small cell lung cancer, prostate cancer, ovarian cancer, head \& neck cancer, gastric cancer or esophageal cancer.

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-14
• Study First Submitted QC: 2019-08-21
• Study First Posted: 2019-08-26
• Study Start: 2019-09-18
• Last Update Submitted: 2019-12-17
• Last Update Posted: 2019-12-18
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1498

Inclusion Criteria

1. Adults ≥18 years old
2. Patients who have signed written consent form prior to participating in the clinical trial
3. Patients who are assessed as adequate to administer Nanoxel M injection.

Exclusion Criteria

1. Patients who have shown severe hypersensitivity to Docetaxel and concomitant drugs

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of Nanoxel M inj.	through study completion, an average of 6cycles(each cycle is 3weeks)	The incidence of Treatment-Emergent Adverse Event

Trial Locations

Locations (1)

Samyang Biopharmaceuticals; 🇰🇷 Seoul, Korea, Republic of