NCT01770795

Brief Summary

To evaluate the efficacy and safety Genexol-PM(CrEL-free polymeric micelle formulated paclitaxel)and gemcitabine in untreated metastatic NSCLC patients

Trial Health

80
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
Last Updated

January 18, 2013

Status Verified

January 1, 2013

Enrollment Period

1.8 years

First QC Date

January 16, 2013

Last Update Submit

January 16, 2013

Conditions

Non-small Cell Lung Cancer

Keywords

non-small cell lung cancergemcitabinegenexol-PMpaclitaxel

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

    one year

Secondary Outcomes (3)

  • progression free survival

    one year

  • overall survival

    one year

  • toxicities

    one year

Study Arms (1)

Genexol-PM/Gemcitabine

EXPERIMENTAL
Drug: Genexol-PM/Gemcitabine

Interventions

Genexol-PM/GemcitabineDRUG
Genexol-PM/Gemcitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age over 18
  • histologically or cytologically confirmted non-small cell lung cancer
  • stage IIIb with pleural effusion or stage IV
  • ECOG PS 0-2
  • at least one measurable lesion
  • expected life span more than 3 months
  • normal bone marrow, liver, renal function
  • no prior chemotherapy or radiotherapy except for whole brain radiotherapy for symptomatic brain metastases
  • more than 6 months from the last adjuvant chemotherapy

You may not qualify if:

  • active infection
  • severe comorbitidies
  • pregnant or lactating women
  • other invasive malignancies
  • poorly controlled symptomatic brain metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Center

Incheon, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 18, 2013

Study Start

January 1, 2011

Primary Completion

October 1, 2012

Last Updated

January 18, 2013

Record last verified: 2013-01

Locations

KR(1)