A Phase II Trial of Genexol-PM and Gemcitabine in Patient... | NCT01770795

Studies
A Phase II Trial of Genexol-PM and Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer

NCT01770795

Sponsor

Gachon University Gil Medical Center

Status

Completed

Last Update Posted

Jan 18, 2013Estimated

Enrollment

45Actual

Phase

Phase 2

Conditions

Non-small Cell Lung Cancer

Interventions

Genexol-PM/Gemcitabine

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Oct 2012Actual

Completion Date

Not provided

First Submitted Date

Jan 16, 2013

First Submission Date that Met QC Criteria

Jan 16, 2013

First Posted Date

Jan 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2013

Last Update Posted Date

Jan 18, 2013Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Label	Type	Description	Intervention Names
Genexol-PM/Gemcitabine	Experimental		Drug: Genexol-PM/Gemcitabine

Name	Type	Description	Arm Group Labels	Other Names
Genexol-PM/Gemcitabine	Drug		Genexol-PM/Gemcitabine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall response rate		one year

Secondary Outcomes

Measure	Description	Time Frame
progression free survival		one year
overall survival		one year
toxicities

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gachon University Gil Medical Center		Incheon			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided