[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.)
Conditions
Interventions
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 ev
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recommended dose: RD | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate: ORR Adverse Events: AE Progression free survival: PFS Overall survival: OS Disease control rate: DCR | — |
Countries
Japan
Contacts
Public ContactAkihito Kawazoe
National Cancer Center Hospital East Department of Gastrointestinal Oncology
Outcome results
None listed