臨床研究等提出・公開システム

A PHASE I, OPEN-LABEL, NON-RANDOMIZED, DOSE-ESCALATING, SAFETY, TOLERABILITY, PHARMACOKINETIC, AND EFFICACY STUDY OF TAS-117 IN PATIENTS WITH ADVANCED SOLID TUMORS

A PHASE I, OPEN-LABEL, NON-RANDOMIZED, DOSE-ESCALATING, SAFETY, TOLERABILITY, PHARMACOKINETIC, AND EFFICACY STUDY OF TAS-117 IN PATIENTS WITH ADVANCED SOLID TUMORS

Taiho Pharmaceutical Co., Ltd.

1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo

toiawaseCD1@taiho.co.jp

Taiho Pharmaceutical Co., Ltd.

1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo

+81-3-3293-2455

toiawase@taiho.co.jp

completed

Feb. 23, 2015

Interventional

Opne-label, non-randomized, dose-escalating, phase I study

treatment purpose

1

1. Provided written informed consent for treatment.
2. Male or female over 20 years.
3. Histologically or cytologically confirmed solid tumor(s), ovarian clear cell carcinoma or PIK3CA/AKT gene alteration endometrial cancer without standard treatment remains.
4. PS 0 or 1
5. Able to take medications orally.
6. Adequate organ function (Fasting serum glucose 160 mg/dL or less, HbA1c 8.0% or less, LDL cholesterol 190 mg/dL or less, Triglycerides 300 mg/dL or less, AST/ALT 3 x ULN or less, if liver function abnormalities are due to underlying liver metastasis, AST/ALT 5 x ULN or less, T-bil 1.5 x ULN or less, Absolute neutrophil count 1500/mm3 or more, Platelet count 75000/mm3 or more, Hb 8.0 g/dL or more, CrCl 50 mL/min or more)

1. History or current evidence of type 1 or type 2 diabetes mellitus that requires insulin and/or oral antidiabetic therapy.
2. Current evidence of retinopathy that requires ophthalmological therapy.
3. History or current evidence of cardiac arrhythmia and/or conduction abnormality.
4. Any anticancer treatment or investigational agent within 3 weeks prior to study drug administration.
5. A serious illness or medical condition(s) including, but not limited to, the following:
a. Known brain metastasis not stable off steroids for over 2 months.
b. Known leptomeningeal metastasis.
c. Known acute systemic infection.
d. Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure.
e. Known severe chronic kidney disease, nausea or diarrhea.
f. Known human immunodeficiency virus or acquired immunodeficiency syndrome related illness, or a history of serum positivity to hepatitis B or C.
6. Unresolved toxicity of Grade >1 attributed to any prior therapies excluding alopecia, skin pigmentation and anemia.
7. Receiving oral steroid medication.
8. Prior therapy with TAS 117.
9. Pregnant or lactating female or females of child-bearing potential who have a positive pregnancy test within 7 days prior to the day on which the study drug is scheduled to be administered.

Both

Patients with advanced solid tumors, ovarian clear cell carcinoma and endometrial cancer.

investigational material(s)
Generic name etc : TAS-117 (AKT inhibitor)
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Oral

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

safety
Safety
Incidences of adverse events and adverse drug reactions

pharmacokinetics
Pharmacokinetics
Calculate the pharmacokinetics parameters of TAS-117

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Jan. 28, 2015