UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031346 |
|---|---|
| Receipt number | 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 | 2020/08/19 17:43:24 |
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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
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
t3mizukami@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035784
