UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003583 |
|---|---|
| Receipt number | R000004346 |
| Scientific Title | Phase I trial of S-1 with Lapatinb for metastatic breast cancer |
| Date of disclosure of the study information | 2010/05/10 |
| Last modified on | 2010/05/09 17:52:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase I trial of S-1 with Lapatinb for metastatic breast cancer
Acronym
Phase I trial of S-1 with Lapatinb for metastatic breast cancer
Scientific Title
Phase I trial of S-1 with Lapatinb for metastatic breast cancer
Scientific Title:Acronym
Phase I trial of S-1 with Lapatinb for metastatic breast cancer
Region
| Japan |
Condition
Condition
metastatic breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate maximum tolerated dose and recommended dose of S-1 and Lapatinib combination chemotherapy for anthracycline, taxane and trastuzumab refractory patients with metastatic breast cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
To evaluate MTD and RD
Key secondary outcomes
Response rate, rate of adverse events
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
Lapatinib is administered intravenously at one hour before or after meal of day 1. S-1 is administered orally for 14 consecutive days followed by a 7 days rest. Cycles are repeated 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
| Not applicable |
Gender
Female
Key inclusion criteria
1.histologically confirmed breast cancer
2.patients diagnosed as metastasisbreast cancer
3.HER2 status was considered positive(grade 3+ staining intensity by means of immunohistochemical analysis or grade 2+ staining intensity by means of immunohistochemical analysis with gene amplification on fluorescence in situ hybridization)
4.anthracycline, taxane and trastuzumab refractory patients
5.patients with evaluable region
6.20 years old or more
7.sufficient function of important organs
Hemoglobin:over9g/dl
WBC: over 4000/mm3 and under 12000/mm3
Neutrophyl:over 2000/mm3
Platelet: over 100000/mm3
T.bil: 2.0 times of normal range in institute
GOT,GPT: 2.0 times of normal range in institute
Left ventricular systolic dysfunction:normal range in institute
serum Creatinin:normal range in institute
Ccr:over 50 ml/min/body
8.Performance Statues: 0-2(ECOG)
9.with ability of oral intake
10.written informed consent
Key exclusion criteria
1.with severe allergy to S-1 or Lapatinib
2.with active double cancer
3.infection,diarrhea,paralysis of intestine and intestinal obstruction which are judged to interfere with treatment,diabetes with incontrollable,and other sever complications
4.with mental disorder which become problem on clinical practice
5.with heart disease which become problem on clinical practice
6.with interstitial pneumonitis or with history of interstitial pneumonitis
7.with heart failure or with history of heart failure
8.with sever bone-marrow suppression, renal disorder,liver disorder
9.with large pleural effusion, or accumulation of ascitic fluid
10.with water diarrhea at the registration
11.treatment with flucytosine
12.pregnant,women who like be pregnant
13.doctor's decision not to be registered to this study
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seigo Nakamura |
Organization
St. Luke's International Hospital
Division name
Breast Center
Zip code
Address
9-1, akashi-cho, chuo-ku, Tokyo, Japan 104-8560
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshida Atsushi |
Organization
St. Luke's International Hospital
Division name
Breast center
Zip code
Address
TEL
Homepage URL
atsuyosi@luke.or.jp
Sponsor or person
Institute
St. Luke's International 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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | 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
| 2010 | Year | 05 | Month | 09 | Day |
Last modified on
| 2010 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004346
