Phase I study of TAS-116 in combination with Nivolumab in patients with progressive or metastatic solid cancer

UMIN ID: UMIN000032801

Registered date:01/06/2018

Basic Information

• Recruitment status: Complete: follow-up complete

Health condition(s) or Problem(s) studied

[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.)

• Date of first enrollment: 2018/06/11
• Target sample size: 48
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: Recommended dose: RD

Secondary Outcome

Objective response rate: ORR
Adverse Events: AE
Progression free survival: PFS
Overall survival: OS
Disease control rate: DCR

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female

Exclude 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)

Related Information

• Primary Sponsor: National Cancer Center Hospital East

Source(s) of Monetary Support

Taiho Pharmaceutical Co., Ltd
Ono Pharmaceutical Co., Ltd