UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019075 |
|---|---|
| Receipt number | R000022054 |
| Scientific Title | Feasibility study of ramucirumab plus irinotecan in patients with advanced gastric cancer |
| Date of disclosure of the study information | 2015/09/20 |
| Last modified on | 2018/07/27 20:16:57 |
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Basic information
Public title
Feasibility study of ramucirumab plus irinotecan in patients with advanced gastric cancer
Acronym
Feasibility study of ramucirumab plus irinotecan in patients with advanced gastric cancer
Scientific Title
Feasibility study of ramucirumab plus irinotecan in patients with advanced gastric cancer
Scientific Title:Acronym
Feasibility study of ramucirumab plus irinotecan in patients with advanced gastric cancer
Region
| Japan |
Condition
Condition
chemo-refractory gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study will evaluate the efficacy of combination therapy with ramucirumab and irinotecan in patients with advanced chemo-refractory gastric cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DLTs
Key secondary outcomes
progression-free survival, time to treatment failure, response rate, disease control rate, adverse events, relative dose intensity
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
Ramucirumab:
8 mg/kg, day1, biweekly
Irinotecan:
150 mg/m2, day1, biweekly
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
Male and Female
Key inclusion criteria
1. Histopathologically confirmed adenocarcinoma of gastric or gastroesophageal junction (GEJ) with inoperable, locally advanced or metastatic disease, not amenable to curative therapy.
2. Documented objective radiographic or clinical disease progression after chemotherapy.
3. Measurable disease or non-measurable but evaluable disease, according to RECIST criteria version 1.1.
4. Age >= 20 years.
5. ECOG PS of 0 or 1.
6. Sufficient oral intake.
7. Adequate organ function.
8. Life expectancy of at leaset 3 months.
9. Written informed consent obtained prior to any study specific procedures.
Key exclusion criteria
1. History of another malignancy which could affect compliance with the protocol or interpretation of result of the study.
2. Previous systemic chemotherapy with irinotecan.
3. Uncontrolled arterial hypertension (e.g. >= 150 / >= 90 mmHg despite standard medical management)
4. Active infection requiring intravenous antibiotics at entry.
5. Serious illness or medical conditions.
6. Uncontrolled diarrhea which disrupt daily life despite fully medical management.
7. History of severe allergy or hypersensitivity for any drugs.
8. Moderate or large ascites or pleural effusion.
9. Chronic daily treatment with oral cortisteroid treatment.
10. Evidence of psychological disorder.
11. Symptomatic evidence of known central nervous system metastases or carcinomatous meningitis.
12. Daily treatment with atazanavir sulfate.
13. Pregnant or breastfeeding, or unwilling to practice contraception during the study.
14. Known acute or choric-active infection with HBV or HCV.
15. Any condition that suggest that the patient is, in the investigator's opinion, not an appropriate candidate for the study.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taroh Satoh |
Organization
Osaka Univesity
Division name
Department of Frontier Science for Cancer and Chemotherapy
Zip code
Address
2-2, Yamadaoka, Suita, Osaka, JAPAN
TEL
06-6879-5111
taroh@cfs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Sakai |
Organization
Osaka Univesity
Division name
Department of Frontier Science for Cancer and Chemotherapy
Zip code
Address
2-2, Yamadaoka, Suita, Osaka, JAPAN
TEL
06-6879-5111
Homepage URL
dsakai@cfs.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2015 | Year | 09 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 09 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 21 | 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
| 2015 | Year | 09 | Month | 19 | Day |
Last modified on
| 2018 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022054
