Study to Evaluate the Safety of Nanoxel M Inj.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1498 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-18

Study Completion Date

2024-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Breast Cancer Non-small Cell Lung Cancer Prostate Cancer Ovarian Cancer Head and Neck Cancer Gastric Cancer Esophageal Cancer

Keywords

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Observational Study, Safety, Nanoxel M, Docetaxel

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Samyang Biopharmaceuticals

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Mi-ryung Jin

Role: primary

Other Identifiers

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DPM401

Identifier Type: -

Identifier Source: org_study_id