UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009067
Receipt number R000010642
Scientific Title Phase I trial of Gemcitabine plus nab-Paclitaxel for metastatic breast cancer
Date of disclosure of the study information 2012/10/16
Last modified on 2016/06/20 08:43:10

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Basic information

Public title

Phase I trial of Gemcitabine plus nab-Paclitaxel for metastatic breast cancer

Acronym

Phase I trial of Gemcitabine plus nab-Paclitaxel for metastatic breast cancer

Scientific Title

Phase I trial of Gemcitabine plus nab-Paclitaxel for metastatic breast cancer

Scientific Title:Acronym

Phase I trial of Gemcitabine plus nab-Paclitaxel for metastatic breast cancer

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate tolerared dose and recommended dose of Gemcitabine and nab-Paclitaxel combination chemotherapy for metastatic breast cancer

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

To determinate maximum tolerated dose and recommended dose

Key secondary outcomes

To determinate pharmacokinetics of nab-Paclitaxel and to validate feasibility


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Gemcitabine:1250mg/m2 day1,8
nab-Paclitaxel:180mg/m2-260mg/m2 day1
every 3 weeks

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

75 years-old >=

Gender

Female

Key inclusion criteria

1)Histrogical confirmed primary breast cancer
2)Clinically confirmed metastatic breast cancer
3)HER2 negative confirmed by IHC or FISH
4)Age are 20-75 years old
5)None primary treatment with Paclitaxel and Gemcitabine
*More than 6 months from Neo-adjuvant or adjuvant chemotherapy by paclitaxel or Gemcitabine
6)Required baseline primary treastment
More than 4 weeks from surgery
More than 2weeks from radiotherapy or endocrine therapy
7)Performance status of 0 or 1
8)Required baseline laboratory date
WBC:4000/mm3-12000/mm3
Neu:>=4000/mm3
Plt:>=100000/mm3
Hb:>=9.0g/dL
ALT and AST:<2.5 times of nomal range in institute
T-Bil:<=1.5mg/dL
Cr:<=1.5mg/dL
9)Expected survival time:more than 3 months
10)Written informed consent

Key exclusion criteria

1)Allergy of the Gemcitabine or nab-Paclitaxel
2)Contraindication to treatment with Gemcitabine or nab-Paclitaxel
3)With sever complications
ex.)with incontrollable diabetes,with infection,mental disorder which become problem on clinical practice
4)During pregnancy or lactation
5)With extensive liver metastases, or lymphatic vessel-related metastases to lung with dyspnea
6)With active double cancer
7)With symptomatic brain cancer
8)HBs antigen is positive
9)With uncontrollable hypertension, angina, congestive heart failure, myocardial infection within 1 year, arrhythmia, valvular heart disease
10)With pulmonary fibrosis or pneumonitis
11)With dyspnea at rest
12)With uncontrolled pleural effusion, peritoneal effusion, pericardial effusion
13)With grade 2 or grater peripheral neuropathy
14)Patients judged by the investigator as unfit to be enrolled in the study

Target sample size

9


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naruto Taira

Organization

Okayama University Hospital

Division name

Breast and endocrical surgery

Zip code


Address

2-5-1 Shikata-machi Kita-ku Okaya-shi

TEL

086-235-7265

Email

ntaira@md.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naruto Taira

Organization

Okayama University Hospital

Division name

Breast and endocrical surgery

Zip code


Address

2-5-1 Shikata-machi Kita-ku Okaya-shi

TEL

086-235-7265

Homepage URL


Email

ntaira@md.okayama-u.ac.jp


Sponsor or person

Institute

Okayama Univesity Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2012 Year 10 Month 16 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/27316438

Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 09 Month 12 Day

Date of IRB


Anticipated trial start date

2012 Year 11 Month 01 Day

Last follow-up date

2014 Year 05 Month 15 Day

Date of closure to data entry

2014 Year 05 Month 27 Day

Date trial data considered complete

2014 Year 05 Month 27 Day

Date analysis concluded

2014 Year 05 Month 27 Day


Other

Other related information



Management information

Registered date

2012 Year 10 Month 09 Day

Last modified on

2016 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010642


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name