NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000028405

Registered date:27/07/2017

Phase 1b investigator initiated trial of combination therapy of Metformin and Nivolumab in participants with advanced or recurrent solid cancer.

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studied<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
Date of first enrollment2017/08/25
Target sample size39
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Continue to administer Nivolumab and Metformin to a patient until the patient correspond to the withdrawal criteria for individual subjects

Outcome(s)

Primary Outcome1) 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
Secondary Outcome1) Efficacy - Response rate - Progression-free survival - Overall survival 2) Estimation of effective blood concentration of metformin

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1)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

Related Information

Contact

public contact
Name Tatsushi Goto
Address Urban Ace Higashitenma-BLDG, 1-1-19, Higashitenma,Kita-ku,Osaka 530-0044 Japan Japan 5300044
Telephone 06-6358-7110
E-mail gotou@fiverings.co.jp
Affiliation Fiverings Co.,Ltd. Medical team
scientific contact
Name Katsuyuki Kiura
Address 2-5-1, Shikata-cho, Kita-Ku, Okayama-city, Okayama 700-8558 Japan Japan
Telephone 086-223-7151
E-mail kkiura@md.okayama-u.ac.jp
Affiliation Okayama University Hospital Department of Allergy and Respiratory Medicine