UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010125 |
|---|---|
| Receipt number | 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 15:12:37 |
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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
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
masaru.iwai@tokushukai.jp
Sponsor or person
Institute
Tokyo-West Tokushukai 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011858
