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

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 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

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

Value
https://center6.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