UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021949 |
|---|---|
| Receipt number | R000025174 |
| Scientific Title | A phase I trial of biweekly nab-paclitaxel plus ramucirumab in patients with previously treated advanced gastric cancer |
| Date of disclosure of the study information | 2016/05/23 |
| Last modified on | 2016/04/08 12:32:39 |
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Basic information
Public title
A phase I trial of biweekly nab-paclitaxel plus ramucirumab in patients with previously treated advanced gastric cancer
Acronym
Biweekly nab-paclitaxel plus ramucirumab in patients with previously treated advanced gastric cancer
Scientific Title
A phase I trial of biweekly nab-paclitaxel plus ramucirumab in patients with previously treated advanced gastric cancer
Scientific Title:Acronym
Biweekly nab-paclitaxel plus ramucirumab in patients with previously treated advanced gastric cancer
Region
| Japan |
Condition
Condition
metastatic or recurrent gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The sefety of nab-paclitaxel plus ramucirumab combination as second line therapy in patients with advanced gastric cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Maximum tolerated dose, recommended dose
Key secondary outcomes
adverse events, overall response rate, disease control 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
Nab-paclitaxel is administered 100mg/m2 given intravenously in a 2-week cycle. Ramurcirumab is administered 8mg per body weight intravenously in a 2-week cycle.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)written informed consent got from the patient
2)patient who has histologically or cytologically confirmed gastric adenocarcinoma
3)patient who previously treated with fluorouracil regimens for advanced gastric cancer, and who is refractory or intolerant to them
4)patient with an ECOG Performance Status of between 0 and 1
5)patient is >=20 years old and <80 years old
6)patient who has a life expectancy of at least 90 days
7)patient who has adequate main organ functions in tests within 2 weeks before enrollment
a)haemoglobin concentorarion >=8.0 g/dL
b)white blood cell(WBC) count >=3,000/mm3 or neutrophil count >=1,500/mm3, and WBC count <=12,000/mm3
c)platelet count >=100,000/mm3
d)serum total bilirubin level <=one and a half times as many as average level baseline
e)serum AST and ALT levels two and a half times as many as average level baseline
f)serum creatinine <=1.5 mg/dL
Key exclusion criteria
1)patient with allergy of paclitaxel or ramucirumab
2)patient with contraindication for paclitaxel or ramucirumab
3)patient who had previously administered with paclitaxel as first line therapy
4)patient who has a serious infection
5)patient who has serious complications such as heart disease, respitary disorder, cerebrovascular disorder, liver disease and much ascites or pleural effusion
6)patient who has recieved chemotherapy within 2weeks
7)patient who has recieved therapy with blood products
8)patient with other malignat tumor
9)patient with neuropathy (>=grade 2)
10)patient with urinary protein (>=grade 2)
11)patient with brain symptomatic metastasis
12)patient who recieved with steroid
13)patient with psychic disorder
14)patient with pregnancy, lactating or possibility of pregnancy
15)patient who given a dicision of unsuitable for this study by the investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuji Takayama |
Organization
Institute of Biomedical Sciences, Tokushima University Graduate School
Division name
Gastroenterology and Oncology
Zip code
Address
3-18-15 Kuramoto Tokushima-city, Tokushima Japan
TEL
088-633-7124
takayama@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuji Takayama |
Organization
Institute of Biomedical Sciences, Tokushima University Graduate School
Division name
Gastroenterology and Oncology
Zip code
Address
3-18-15 Kuramoto Tokushima-city, Tokushima Japan
TEL
088-633-7124
Homepage URL
takayama@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University 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
None
Name of secondary funder(s)
None
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
徳島大学病院（徳島県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 23 | 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
| 2016 | Year | 04 | Month | 17 | Day |
Last modified on
| 2016 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025174
