![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | No longer 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 | 2020/10/30 |
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 |
|
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 |
|
|||||||
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 - Overall survival 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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 corical steroids or immunosuppressive agents within last 3 weeks 22)Patients with history of cancer immunotherapy 23)Radiation therapy within last 4 weeks 24)Patient who have or plan to have live vaccination within last 28 days 25)Pregnant or lactating females, female and male patients who cannot agree to practice the adequate birth control after the consent during the study 26)Serious infection or inflammatory disease 27)Patients with psychosis or dementia to interfere to obtain informed consent appropriately 28)Patients who received a transplantation therapy 29)Patients who have obviously metastasis to central nervous system or pia mater 30)Patients who have tumor originated from central nervous system 31)Any other inadequacy for this study |
|||
Target sample size | 39 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
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 | ||||||
kkiura@md.okayama-u.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
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 | |||||||
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 | - |
- |
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 |
|
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 41 |
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
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 |