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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030372
Receipt No. R000034675
Scientific Title Phase II study of ramucirumab and irinotecan combination therapy as second-line treatment in patients with metastatic or advanced gastric cancer
Date of disclosure of the study information 2017/12/13
Last modified on 2019/10/06

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Basic information
Public title Phase II study of ramucirumab and irinotecan combination therapy as second-line treatment in patients with metastatic or advanced gastric cancer
Acronym HGCSG 1603
Scientific Title Phase II study of ramucirumab and irinotecan combination therapy as second-line treatment in patients with metastatic or advanced gastric cancer
Scientific Title:Acronym HGCSG 1603
Region
Japan

Condition
Condition Gastric Cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Assessment of the efficacy and safety of ramucirumab and irinotecan combination therapy in metastatic or advanced gastric cancer refractory to initial chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes progression-free survival rate at six months (PFS rate at 6 months)
Key secondary outcomes overall survival, progression-free survival, response rate, safety, and dose intensity for each drug

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Antitumor agents
Irinotecan
Ramucirumab
every two 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 Male and Female
Key inclusion criteria 1. Confirmed stage IV or recurrent gastric adenocarcinoma that is refractory or intolerant to initial chemotherapy.
2. Age of 20 years or older.
3. ECOG PS scale 0-1.
4. No history of treatment with irinotecan.
5. Confirmation of the progression or recurrence following initial treatment and potential presence of an evaluable lesion less than 28 days before registration using CT or MRI findings, according to RECIST version 1.1. Presence or absence of a measurable lesion is not an inclusion criterion.
6. Last day of initial chemotherapy administration is more than 14 days before registration.
7. Fulfillment of the standards related to major organ functions within 14 days before registration.
8. Patients who are negative for HER-2/neu and those with unknown HER-2/neu status are eligible. HER-2/neu-positive patients are eligible if they received treatments including trastuzumab and if the disease progress is confirmed.
9. Available written informed consent.
10. Have an estimated life expectancy of > 12 weeks in the judgment of the investigator.
11. The patient, if female, is surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method (failure rate < 1%) during and for 12 weeks after the treatment period.
Key exclusion criteria 1. Major surgery within 28 days before registration.
2. The patient has a history of DVT, PE, or any other significant thromboembolism during the 3 months prior.
3. Administration of anticoagulant therapy such as warfarin and LMWH.
4. The patient is receiving chronic therapy with nonsteroidal anti-inflammatory agents or other anti-platelet agents.
5. Have documented brain metastases, leptomeningeal disease or uncontrolled spinal cord compression.
6. Diagnosis of arterial hypertension that cannot be controlled with standard medical management.
7. The patient has a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to first dose of protocol therapy.
8. Primary cancers diagnosed within the previous five years.
9. The patient has symptomatic congestive heart failure or symptomatic or poorly controlled cardiac arrhythmia.
10. The patient has experienced any arterial thrombotic event within 6 months prior.
11. Serious complications or comorbidities.
12. The patient has experienced any Grade 3-4 GI bleeding within 3 months prior to first dose of protocol therapy.
13. History of gastrointestinal perforation and/or fistulae within 6 months prior to registration.
14. Pericardial or pleural effusion or ascites requiring treatment including drainage.
15. Pregnancy, breast-feeding, or plans of pregnancy.
16. Local or systemic active infection requiring treatment; however, HBs-Ag positive patients controlled by nucleic acid analogs and those confirmed as HBV DNA can be enrolled.
17. Current or recent treatment with another investigational drug or participation in another interventional clinical trial.
18. Have known allergy or hypersensitivity to any components of study treatment.
19. The patient has: cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis.
20. Participation in the clinical trial is determined as unsuitable.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name Yoshito
Middle name
Last name Komatsu
Organization Hokkaido University Hospital
Division name Department of Cancer Center
Zip code 060-8648
Address Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL 011-706-5657
Email ykomatsu@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Yasuyuki
Middle name
Last name KAWAMOTO
Organization Hokkaido University Hospital
Division name Department of Cancer Center
Zip code 060-8648
Address Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL 011-706-5657
Homepage URL
Email y-kawamoto0716@hotmail.co.jp

Sponsor
Institute Hokkaido Gastrointestinal Cancer Study Group (HGCSG)
Institute
Department

Funding Source
Organization Eli Lilly Japan K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Research and Medical Innovation Center, Hokkaido University Hospital
Address Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
Tel 0117067636
Email crjimu@huhp.hokudai.ac.jp

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
2017 Year 12 Month 13 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 No longer recruiting
Date of protocol fixation
2017 Year 12 Month 20 Day
Date of IRB
2017 Year 12 Month 19 Day
Anticipated trial start date
2017 Year 12 Month 21 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 13 Day
Last modified on
2019 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034675

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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