UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of ramucirumab plus irinotecan in patients with advanced gastric cancer
Title of the study (Brief title)	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	Taroh Satoh
Organization	Osaka Univesity
Division name	Department of Frontier Science for Cancer and Chemotherapy
Address	2-2, Yamadaoka, Suita, Osaka, JAPAN
TEL	06-6879-5111
Email	taroh@cfs.med.osaka-u.ac.jp

Public contact
Name of contact person	Daisuke Sakai
Organization	Osaka Univesity
Division name	Department of Frontier Science for Cancer and Chemotherapy
Address	2-2, Yamadaoka, Suita, Osaka, JAPAN
TEL	06-6879-5111
Homepage URL
Email	dsakai@cfs.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 09 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022054