UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032801 |
|---|---|
| Receipt number | R000037236 |
| Scientific Title | Phase I study of TAS-116 in combination with Nivolumab in patients with progressive or metastatic solid cancer |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2021/02/22 13:58:42 |
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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
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
TAS116nivo_core@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037236
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