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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031346
Receipt No. R000035784
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
Date of disclosure of the study information 2018/02/28
Last modified on 2019/08/20

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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
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 Open public 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
2019 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
2019 Year 08 Month 20 Day


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

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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