UMIN-CTR Clinical Trial

Basic information
Public title	Phase I study of TAS-116 in combination with Nivolumab in patients with progressive or metastatic solid cancer
Acronym	TAS116nivo_study
Scientific Title	Phase I study of TAS-116 in combination with Nivolumab in patients with progressive or metastatic solid cancer
Scientific Title:Acronym	TAS116nivo_study
Region	Japan

Condition
Condition	[Dose escalation cohort] Progressive or metastatic solid tumors (regardless of cancer types) [Expansion cohort] Advanced or metastatic solid tumors (stomach cancer, lung cancer, pancreatic cancer, biliary tract cancer, etc.)
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy and safety of TAS-116 in combination with Nivolumab in patients with progressive or metastatic solid cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Recommended dose: RD
Key secondary outcomes	Objective response rate: ORR Adverse Events: AE Progression free survival: PFS Overall survival: OS Disease control rate: DCR

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	1 course is 28 days. [Dose escalation cohort] TAS-116(80mg or 120mg or 160mg) is administered orally once daily for 5 days and then 2 days rest. Repeat for 4 weeks. Nivolumab (3mg/kg) is injected every 2 weeks. [Expansion cohort] TAS-116 (Recommend dose from Dose escalation cohort) is administered orally once daily for 5 days and then 2days rest. Repeat for 4 weeks. Nivolumab (3mg/kg) is injected every 2 weeks.
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) Patients with written informed consent. 2)>=20 years old 3) <Dose escalation cohort> - Patients with histologically or cytologically confirmed advanced or metastatic solid tumor. (Regardless of cancer types.) <Expansion cohort> - Patients with histologically or cytologically confirmed advanced or metastatic solid tumor. (Stomach cancer, lung cancer, pancreatic cancer, biliary tract cancer etc.) - Patients confirmed progressive disease on the image during or within 2 months after the most recent treatment (not necessarily satisfy the exacerbation criteria in RECIST version 1.1) 4) Patients with ECOG performance status 0 or 1. 5) Patients capable of taking oral medication. 6) Patients with at least one measurable lesion as defined by RECIST ver. 1.1. 7) Laboratory test values within 14 days prior to registration fulfill the criteria: 8) No. of prior chemotherapies>=1. 9) Women of childbearing potential agree to use double contraception methods and not to breast-feed from informed consent to after at least 5 months of final administration. Men agree to take double contraception from first dose and after at least 7 months of final dose.
Key exclusion criteria	1) Received systemic chemotherapy, radiotherapy, surgery, hormonal therapy, immunotherapy within 2weeks prior to enrollment. 2) Patients with therapeutic history of TAS-116 3) Patients with a history of acute coronary syndrome (including myocardial infarction and unstable angina), coronary angioplasty, or stent placement within 6 months prior to enrollment 4) Patients with a large amount of pleural effusion or ascites requiring drainage 5) Patients with grade 3 or higher active infections according to CTCAE v 4.0 6) Patients with symptomatic brain metastases 7) Patients with gastrointestinal obstruction or incomplete obstruction 8) Patients with interstitial lung disease with active symptoms or signs 9) Either HIV antibody, HBs antigen or HCV antibody test is positive. Positive HBs antibody or HBc antibody test with HBV-DNA quantification above threshold. 10) Patients with autoimmune disease complications or a history of chronic or recurrent autoimmune disease 11) Patients requiring systemic adrenocortical hormone or an immunosuppressant, or patients received these treatments within 14 days prior to enrollment 12) Patients with a history or finding of congestive heart failure of NYHA classification III or higher 13) Patients with seizure disorder requiring drug treatment 14) Patients with a history of hypersensitivity to investigational drugs, similar drugs or excipients 15) Pregnant women, lactating women or possibly pregnant women 16) Patients with corrected eyesight of both eyes less than 0.5 (using the Universal Testing Power Table)
Target sample size	48

Research contact person
Name of lead principal investigator	1st name Kohei Middle name Last name Shitara
Organization	National Cancer Center Hospital East
Division name	Department of Gastrointestinal Oncology
Zip code	277-8577
Address	6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
TEL	04-7133-1111
Email	TAS116nivo_core@east.ncc.go.jp

Public contact
Name of contact person	1st name Akihito Middle name Last name Kawazoe
Organization	National Cancer Center Hospital East
Division name	Department of Gastrointestinal Oncology
Zip code	277-8577
Address	6-5-1,Kashiwanoha,Kashiwa,Chiba, 277-8577,Japan
TEL	04-7133-1111
Homepage URL
Email	TAS116nivo_core@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB of National Cancer Center Hospital
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel	03-3542-2511
Email	irboffice@east.ncc.go.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	国立研究開発法人　国立がん研究センター東病院（千葉県） 国立研究開発法人　国立がん研究センター中央病院（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 01 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	Completed
Date of protocol fixation	2018 Year 03 Month 27 Day
Date of IRB	2018 Year 05 Month 16 Day
Anticipated trial start date	2018 Year 06 Month 11 Day
Last follow-up date	2020 Year 07 Month 31 Day
Date of closure to data entry	2020 Year 09 Month 28 Day
Date trial data considered complete	2020 Year 11 Month 05 Day
Date analysis concluded	2020 Year 12 Month 25 Day

Other
Other related information

Management information
Registered date	2018 Year 05 Month 31 Day
Last modified on	2021 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037236