UMIN-CTR Clinical Trial

Basic information
Public title	A phase I/II trial of TAS-102 in combination with irinotecan in Japanese patients with advanced gastric cancer refractory to standard chemotherapies
Acronym	A phase I/II trial of TAS-102 in combination with irinotecan in Japanese patients with advanced gastric cancer refractory to standard chemotherapies(T-SCAN study)
Scientific Title	A phase I/II trial of TAS-102 in combination with irinotecan in Japanese patients with advanced gastric cancer refractory to standard chemotherapies
Scientific Title:Acronym	A phase I/II trial of TAS-102 in combination with irinotecan in Japanese patients with advanced gastric cancer refractory to standard chemotherapies(T-SCAN study)
Region	Japan

Condition
Condition	advanced gastric cancer refractory to standard chemotherapies
Classification by specialty	Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To establish the maximum tolerated dose (MTD) and DLTs in Japanese patients with advanced gastric cancer to determine the recommended phase II dose (RP2D)
Basic objectives2	Others
Basic objectives -Others	To examine the efficacy and safety of RP2D of TAS-102 and irinotecan
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Phase I part: the incidence of dose limiting toxicities (DLTs) in each level. Phase II part: Disease control rate (DCR)
Key secondary outcomes	Phase I part: the incidence of adverse events Phase II part: Overall response rate (ORR), Overall survival (OS), Progression-free survival (PFS), safety

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	Level 1a TAS-102: 35 mg/m2 twice daily, after the morning and evening meal, for 5 days a week with 2 days rest for 2 weeks, followed by a 14-day rest. Irinotecan: 100mg/m2/day, administered by intravenous infusion over at least 90 min on Days 1 and 15 in a 28-day schedule Level 1b TAS-102: 35 mg/m2 twice daily, after the morning and evening meal, for 5 days a week with 9 days rest. Irinotecan: 100mg/m2/day, administered by intravenous infusion over at least 90 min on Day 1 in a 14-day schedule Level 2a TAS-102: 35 mg/m2 twice daily, after the morning and evening meal, for 5 days a week with 2 days rest for 2 weeks, followed by a 14-day rest. Irinotecan: 125mg/m2/day, administered by intravenous infusion over at least 90 min on Days 1 and 15 in a 28-day schedule Level 2b TAS-102: 35 mg/m2 twice daily, after the morning and evening meal, for 5 days a week with 9 days rest. Irinotecan: 125mg/m2/day, administered by intravenous infusion over at least 90 min on Day 1 in a 14-day schedule
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	Eligible patients are Japanese patients aged >=20 years with: - Histological confirmation of advanced gastric adenocarcinoma - Patient with oral intake - ECOG performance score of 0 or 1 - Patients with measurable lesions - Disease refractory to fluoropyrimidine, platinum and taxane. - Adequate organ function as defined by the following criteria: 1.Absolute neutrophil count (ANC) >= 1,500/ul 2.Platelets >= 100,000/ul 3.Hemoglobin >= 8.0 g/dl 4.AST and ALT <= 2.5 x ULN (without known liver metastasis), <= 5.0 x ULN (with known liver metastasis) 5.Total bilirubin <= 1.5 mg/dL 6.Serum creatinine <= 1.5 mg/dL 7.PT- INR <= 1.5 8.Diarrhea <= Grade 1 9.UGT1A1*6*28 wild type or single hetero - Written informed consent
Key exclusion criteria	- With a treatment history of TAS-102 or irinotecan - Serious illness such as brain metastasis, systemic infection or gastrointestinal bleeding - Medical treatment such as major surgery within 4 weeks, systemic chemotherapy within 2 weeks - Adverse events due to prior chemotherapy - Administration of blood transfusion or G-CSF within 2 weeks - Severe pulmonaly disorder - Thromboembolism (grade3 or higher) within 6 months - Inappropriate for the study in the opinion of the investigator
Target sample size	28

Research contact person
Name of lead principal investigator	1st name Takako Middle name Eguchi Last name Nakajima
Organization	St. Marianna University School of Medicine Hospital
Division name	Department of Clinical Oncology
Zip code	2168511
Address	Sugao 2-16-1, Miyamae, Kawasaki, Kanagawa, Japan
TEL	044-977-8111
Email	tnakajima@marianna-u.ac.jp

Public contact
Name of contact person	1st name Takuro Middle name Last name Mizukami
Organization	St. Marianna University School of Medicine Hospital
Division name	Department of Clinical oncology
Zip code	2168511
Address	Sugao 2-16-1, Miyamae, Kawasaki, Kanagawa, Japan
TEL	044-977-8111
Homepage URL
Email	t3mizukami@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	Taiho Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Chiba Cancer Center, Gastroenterology
Name of secondary funder(s)

IRB Contact (For public release)
Organization	St.Marianna University School of Medicine
Address	Sugao 2-16-1, Miyamae, Kawasaki, Kanagawa
Tel	044-977-8111
Email	t3mizukami@marianna-u.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	2018 Year 02 Month 28 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	11
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 01 Day
Date of IRB	2018 Year 01 Month 11 Day
Anticipated trial start date	2018 Year 02 Month 28 Day
Last follow-up date	2020 Year 05 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	2018 Year 02 Month 17 Day
Last modified on	2020 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035784