A Phase II Trial of Doxorubicin and Genexol-PM in Patient... | NCT01784120

Studies
A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer

NCT01784120

Sponsor

Gachon University Gil Medical Center

Status

Unknown status

Last Update Posted

Feb 10, 2016Estimated

Enrollment

48Estimated

Phase

Phase 2

Conditions

Metastatic Breast Cancer

Interventions

Doxorubicin/Genexol-PM

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

Feb 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jan 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Jan 30, 2013

First Submission Date that Met QC Criteria

Feb 3, 2013

First Posted Date

Feb 5, 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

Feb 9, 2016

Last Update Posted Date

Feb 10, 2016Estimated

Description Module

Brief Summary

To evaluate efficacy and toxicity of doxorubicin/Genexol-PM in metastatic breast cancer

Primary Purpose: response rate
Secondary purpose: toxicity, progression-free survival, overall survival

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

48Estimated

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

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
response rate		one year

Secondary Outcomes

Measure	Description	Time Frame
number of participants with adverse events		one year

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age or older adult women
Instrumentation measurable lesions with histologically confirmed advanced (recurrent or metastatic) breast cancer
ECOG 0-2
Advanced breast cancer in the past, patients who did not receive chemotherapy
Recurrence if adjuvant chemotherapy and adjuvant chemotherapy in the past for more than 6 months until the patient
life expectancy more than 3 months
Agree in writing before the party to participate in a clinical trial to patients

Exclusion Criteria:

immunohistochemical staining 3 + or FISH positive anti-HER 2 therapy patients
Severe infections requiring antibiotic therapy
Clinically significant heart disease
Pregnant or lactating woman
Uncontrolled symptoms in the central nervous system (CNS) metastases
Patients diagnosed with malignant tumors of other organs

Accepts Healthy Volunteers

Sex

Female

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

Name	Role	Phone	Extension	Email
Hee Kyung Ahn	Contact	+82-32-460-3229		hkahn@gilhospital.com

Overall Officials

Not provided

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004317	Doxorubicin
C000708971	genexol-PM

Ancestor Terms

ID	Term
D003630	Daunorubicin
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided