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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010125
Receipt No. R000011858
Scientific Title Phase 1 trial of Nab-paclitaxel and Gemcitabine for metastatic breast cancer
Date of disclosure of the study information 2013/02/26
Last modified on 2016/09/07

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Basic information
Public title Phase 1 trial of Nab-paclitaxel and Gemcitabine for metastatic breast cancer
Acronym Phase 1 trial of Nab-paclitaxel and Gemcitabine for metastatic breast cancer
Scientific Title Phase 1 trial of Nab-paclitaxel and Gemcitabine for metastatic breast cancer
Scientific Title:Acronym Phase 1 trial of Nab-paclitaxel and Gemcitabine for metastatic breast cancer
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate maximum tolerated dose and recommended dose of nab-Paclitaxel and Gemcitabine 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 Safety, Response rate

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:800-1250mg/m2 day1,8
nab-Paclitaxel:220-260mg/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) Histologically confirmed breast cancer
2) Inoperative metastatic or recurrent breast cancer
3) Patients with evaluable lesion
4) Age are 20-75 years old
5) Prior chemotherapy regimen for metastatic breast cancer until one
6) Adequate baseline organ and marrow function as defined below:
hemoglobin: >=9.0 g/dL
WBC count: >=4,000/mm3
neutrophil count: >=2,000/mm3
platelet count: >=100,000 mm3
total bilirubin: =<1.5 mg/dL
AST(GOT): =<ULN x 2.5
ALT(GPT): =<ULN x 2.5
serum creatinine: =<1.5 mg/dL
7) ECOG performance status (PS) 0-1
8) Patients who have passed the following periods from previous treatment
(1)Endocrinetherapy:7 days from the final administration
(2)Adjuvant:6 months from the final administration
(3)Chemotherapy:14 days from the final administration
9) Written informed consent
Key exclusion criteria 1) Inflammatory and bilateral breast cancer
2) HER2 positive confirmed by IHC or FISH
3) Active another cancer
4) History of hypersensitivity reaction
5) Other severe complications, such as pulmonary emphysema or pulmonary fibrosis, uncontrollable diabetes, heart failure, renal insufficiency, liver failure
6) Neuropathy <= grade1
7) Radiation therapy for chest
8) Serious myelosuppression
9) Infection
10) Pregnant or possibility pregnancy or nursing woman
11) History of hypersensitivity for albumin
12) Physician judged improper to entry this trial
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Sato
Organization Tokyo-West Tokushukai Hospital
Division name Breast Oncology Center
Zip code
Address 3-1-1, Matsubara-cho, Akishima-city, Tokyo
TEL 042-500-4433
Email kazsato@lake.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaru Iwai
Organization Tokyo-West Tokushukai Hospital
Division name Department of Pharmacy
Zip code
Address 3-1-1, Matsubara-cho, Akishima-city, Tokyo
TEL 042-500-4433
Homepage URL
Email masaru.iwai@tokushukai.jp

Sponsor
Institute Tokyo-West Tokushukai Hospital
Institute
Department

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 東京西徳洲会病院(東京都)、湘南鎌倉総合病院(神奈川県)、羽生総合病院(埼玉県)、中部徳洲会病院(沖縄県)、大垣徳洲会病院(岐阜県)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
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
2011 Year 05 Month 27 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 26 Day
Last modified on
2016 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011858

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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