Clinical Trials Logo
  1. Home
  2. Breast Cancer
  3. NCT04066335
  4. Details
NCT04066335 Clinical Trial

Study to Evaluate the Safety of Nanoxel M Inj.

Breast Cancer Clinical Trial

Official title:
An Observational Study to Evaluate the Safety of Nanoxel M (Docetaxel-PM) Inj.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04066335
Other study ID # DPM401
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 18, 2019
Est. completion date August 2024

Study information
Verified date August 2019
Source Samyang Biopharmaceuticals Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1498
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Samyang Biopharmaceuticals Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samyang Biopharmaceuticals Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety of Nanoxel M inj. The incidence of Treatment-Emergent Adverse Event through study completion, an average of 6cycles(each cycle is 3weeks)
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2