NCT04066335

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,498

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
23 days until next milestone

Study Start

First participant enrolled

September 18, 2019

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

December 18, 2019

Status Verified

August 1, 2019

Enrollment Period

4.9 years

First QC Date

August 14, 2019

Last Update Submit

December 17, 2019

Conditions

Breast CancerNon-small Cell Lung CancerProstate CancerOvarian CancerHead and Neck CancerGastric CancerEsophageal Cancer

Keywords

Observational Study, Safety, Nanoxel M, Docetaxel

Outcome Measures

Primary Outcomes (1)

  • Safety of Nanoxel M inj.

    The incidence of Treatment-Emergent Adverse Event

    through study completion, an average of 6cycles(each cycle is 3weeks)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are assessed as adequate to administer Nanoxel M inj.

You may qualify if:

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

You may not qualify if:

  • \) Patients who have shown severe hypersensitivity to Docetaxel and concomitant drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samyang Biopharmaceuticals

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Non-Small-Cell LungProstatic NeoplasmsOvarian NeoplasmsHead and Neck NeoplasmsStomach NeoplasmsEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Neoplasms, FemaleEndocrine System DiseasesGonadal DisordersGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesEsophageal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2019

First Posted

August 26, 2019

Study Start

September 18, 2019

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

December 18, 2019

Record last verified: 2019-08

Locations

KR(1)