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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028405
Receipt No. R000031915
Scientific Title Phase 1b investigator initiated trial of combination therapy of Metformin and Nivolumab in participants with advanced or recurrent solid cancer.
Date of disclosure of the study information 2017/07/27
Last modified on 2019/07/09

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Basic information
Public title Phase 1b investigator initiated trial of combination therapy of Metformin and Nivolumab in participants with advanced or recurrent solid cancer.
Acronym Phase 1b investigator initiated trial of combination therapy Metformin and Nivolumab in participants with advanced or recurrent solid cancer.
Scientific Title Phase 1b investigator initiated trial of combination therapy of Metformin and Nivolumab in participants with advanced or recurrent solid cancer.
Scientific Title:Acronym Phase 1b investigator initiated trial of combination therapy Metformin and Nivolumab in participants with advanced or recurrent solid cancer.
Region
Japan

Condition
Condition <Stage 1>
Advanced or recurrent solid cancer
<Stage 2>
Advanced or recurrent non-small cell lung cancer, advanced or recurrent thymic epithelial tumor and advanced or recurrent pancreatic cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 <Stage 1>
To assess safety of the combination therapy and pharmacokinetics property of metformin

<Stage 2>
To assess safety and preliminary efficacy of the combination therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes 1) Safety
- Maximum tolerant dose (MTD):from first administration to last administration (stage 1 only)
- Dose limiting toxicity (DLT): for 4 weeks from first administration (stage 1 only)
- Adverse event:from first administration to 30 days after last administration

2) Pharmacokinetics property of metformin: from cycle 1 day8 to a day before cycle 2 day 1
Key secondary outcomes 1) Efficacy
- Response rate
- Progression-free survival (stage 2 only)

2) Estimation of effective blood concentration of metformin

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 Continue to administer Nivolumab and Metformin to a patient until the patient correspond to the withdrawal criteria for individual subjects
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) Stage 1: advanced or recurrent solid cancer which is histologically or cytologiacally confirmed
2) Stage 2: advanced or recurrent non-small cell lung cancer or pancreatic cancer which is histologically or cytologiacally confirmed
3) Patients with tumor progression after the first standard treatment
4) Eastern Cooperative Oncology Group performance status (ECOG PS) is 0 or 1
5) Age: more than 20 years old at the date of informed consent
6) Patients with no serious disorder of major organs (bone marrow, heart, lung, liver, and kidney)
7) Patients with written informed consent
8) Stage 1: patients who have a target lesion or a non-target lesion designated by RECIST version 1.1
9) Stage 2: patients who have a target lesion designated by RECIST version 1.1
Key exclusion criteria 1) Patients with obviously HIV antibody positive
2) Patients with HCV antibody positive
3) Patients with HBs antigen positive, HBc antibody or HBs antibody positive
4) Autoimmune disease
5) Interstitial lung disease, pulmonary fibrosis, or radiation pneumonitis
6) Have a history or complication of TB
7) Lactic acidosis
8) Undergoing artificial dialysis
9) Serious liver dysfunction
10) Dysfunction in cardiovascular or respiratory system, likely to be a hypoxemia
11) Alcohol addict
12) Patients with history of anaphylaxis induced by component of the study drug or biguanide-based medicine
13) Patients with history of serious (Grade 3) anaphylaxis induced by antibody preparation
14) Uncontrollable hypertension
15) Uncontrollable endocrine disease
16) Patients who have active inflammatory bowel disease or other serious GI chronic conditions associated with diarrhea
17) Diabetes
18) Patients who have unstable angina or myocardial infarction
19) Patients with double cancer
20) Patients who had administration of biguanide-based medicine within last a year
21) Patients who have or plan to have administration of other anti-cancer agents, other study drugs, sustained systemic adrenal cortical steroids or immunosuppressive agents within last 3 weeks
22) Patients with history of cancer immunotherapy
23) Radiation therapy within last 4 weeks
24) Pregnant or lactating females, female and male patients who cannot agree to practice the adequate birth control after the consent during the study
25) Serious infection or inflammatory disease
26) Patients with psychosis or dementia to interfere to obtain informed consent appropriately
27) Patients who received a transplantation therapy
28) Patients who have obviously metastasis to central nervous system or pia mater
29) Patients who have tumor originated from central nervous system
30) Any other inadequacy for this study
Target sample size 39

Research contact person
Name of lead principal investigator
1st name Katsuyuki
Middle name
Last name Kiura
Organization Okayama University Hospital
Division name Department of Allergy and Respiratory Medicine
Zip code 7008558
Address 2-5-1, Shikata-cho, Kita-Ku, Okayama-city, Okayama 700-8558 Japan
TEL 086-223-7151
Email kkiura@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name Tatsushi
Middle name
Last name Goto
Organization Fiverings Co.,Ltd.
Division name Medical team
Zip code 5300044
Address Urban Ace Higashitenma-BLDG, 1-1-19, Higashitenma,Kita-ku,Osaka 530-0044 Japan
TEL 06-6358-7110
Homepage URL
Email gotou@fiverings.co.jp

Sponsor
Institute Okayama University Hospital
Department of Allergy and Respiratory Medicine
Institute
Department

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

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

IRB Contact (For public release)
Organization -
Address -
Tel -
Email -

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 岡山大学病院(岡山県)、独立行政法人国立病院機構四国がんセンター(愛媛県)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 27 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 06 Month 15 Day
Date of IRB
2017 Year 07 Month 18 Day
Anticipated trial start date
2017 Year 08 Month 25 Day
Last follow-up date
2020 Year 12 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
2017 Year 07 Month 27 Day
Last modified on
2019 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031915

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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