Drug-drug interactions study of TAS-115 in patients with solid tumors

JRCT ID: jRCT2031210372

Registered date:11/10/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Advanced or metastatic solid tumor
• Date of first enrollment: 15/12/2021
• Target sample size: 18
• Study type: Interventional

Intervention(s)

The cohort consists of the assessment period of the drug-drug interactions and the period of continuous administration.
The assessment period of the drug-drug interactions;
Day -3: Pioglitazone will be orally administered.
Day -2: Losartan and midazolam will be orally administered.
Day 1- Day 3: TAS-115 will be orally administered with 250 mg once a day.
Day 4: TAS-115 will be orally administered with 250 mg and pioglitazone will be orally administered 30 minutes later.
Day 5: TAS-115 will be orally administered with 250 mg and losartan and midazolam will be orally administered 30 minutes later.

The period of continuous administration;
TAS-115 will be orally administered with 250 mg once daily under fasting conditions (fasting for at least 2 hours before and 1 hour after administration). One cycle of study treatment consists of 21 days. The study treatment was started on Day 1 of Cycle 1. The study drug will be administered for a 5-day on and 2-day off schedule.

Outcome(s)

• Primary Outcome: PK parameters of pioglitazone, losartan and midazolam (Cmax, AUClast, and AUCinf)

Secondary Outcome

- Safety (Incidence and severity of adverse events, clinical laboratory evaluation, vital signs)
- Efficacy of administration with TAS-115 (ORR, DCR, PFS)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Provided written informed consent
(2) Aged 20 or older at the time of consent (If Malignant bone tumor, aged 15 or older at the time of consent)
(3) Has a histologically or cytologically confirmed diagnosis of solid tumor
(4) Patients who did not respond to or cannot tolerate the standard treatment or the similar treatment or for whom no appropriate therapy is available
(5) Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 before administration of study treatment
(6) Has adequate organ function as defined by the following criteria
a. ANC >= 1500 /mm3 (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor [G-CSF])
b. Hemoglobin value of >= 8.0 g/dL excluding measurements within 4 weeks after a transfusion of packed red blood cells or whole blood
c. Platelet count >= 75000 /mm3 (excluding measurements obtained within 3 days after a transfusion of platelets)
d. AST and ALT =< 3 x ULN
e. T-Bil of =< 1.5 x ULN
f. Caluculated Creatinine Clearance =< 50 mL/min
(7) Has a life expectancy of at least 90 days

Exclude criteria

(1) Having a history of the following treatments;
a. History of extensive surgery requiring general anesthesia within 4 weeks before enrollment (it should be confirmed that the surgical wound has been cured before enrollment) ;
b. History of the use of any investigational drug or device within 4 weeks before enrollment;
c. History of radiotherapy within 4 weeks before enrollment;
d. History of anticancer therapy within 2 weeks before enrollment;
e. History of bone marrow transplantation or stem cell transplantation (excluding autologous peripheral stem cell transplantation) ;
f. History of administration of TAS-115;
(2) Any ADR to prior therapy has not resolved to Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (excluding anemia, alopecia, skin hyperpigmentation, peripheral sensory neuropathy and hypertension);
(3) Having diseases considered inappropriate for participation in this study;
(4) Patients who are pregnant, possibly pregnant, or lactating, including if breastfeeding is interrupted.
(5) Female patients of childbearing potential or male patients who do not agree to use appropriate contraception during the following period.
- Women of childbearing potential: During the study period and for 7 months after the last administration.
- Men: During the study period and for 4 months after the last administration.

Related Information

• Primary Sponsor: Motoo Yoshiharu