臨床研究等提出・公開システム

A PHASE 2, OPEN LABEL, SINGLE-ARM STUDY TO ASSESS THE SAFETY AND EFFICACY OF TAS-116 IN PATIENTS WITH ADVANCED GASTROINTESTINAL STROMAL TUMORS (GIST) AFTER DISEASE PROGRESSION ON, OR INTOLERANCE TO IMATINIB, SUNITINIB AND REGORAFENIB

A phase 2 study of TAS-116 in patients with GIST.

41

All treated patients comprised 26/40 (65.0%) males and 14/40 (35.0%) females, with a median age of 62.0 (range, 30-79) years. ECOG PS score was 0 for 28/40 (70.0%) patients and 1 for 12/40 (30.0%) patients.

41 patients were enrolled in this study and 40 patients received the study drug.

Among the ADRs reported at >= 20% across all grades, diarrhea (32/40, 80.0%) was the most common, followed by decreased appetite (18/40, 45.0%), blood creatinine increased (17/40, 42.5%), nausea (16/40, 40.0%), alanine aminotransferase increased (10/40, 25.0%), aspartate aminotransferase increased (9/40, 22.5%) and blood alkaline phosphatase increased (9/40, 22.5%). Among the Grade 3 or higher ADRs reported at >= 10%, diarrhea (9/40, 22.5%) was the most frequently reported, followed by decreased appetite (5/40, 12.5%) and anemia (4/40, 10.0%). No treatment-related deaths occurred during the study.

The estimated median PFS by blinded central radiological review (BCRR) was 4.4 (95% CI, 2.8-6.0) months.

The median OS was estimated at 11.9 (95% CI, 11.0 to not reached) months.

This study suggests that TAS-116 provides a novel and effective treatment option for patients with advanced and treatment resistant GIST.

Sept. 16, 2019

https://www.ejcancer.com/article/S0959-8049(19)30469-1/fulltext

No

Data will not be shared according to the Sponsor policy on data sharing. Taiho policy on data sharing may be found at https://www.taiho.co.jp/en/science/policy/clinical_trial_information_disclosure_policy/index.html.

Taiho Pharmaceutical Co., Ltd.

toiawaseCD1@taiho.co.jp

Taiho Pharmaceutical Co., Ltd.

toiawase@taiho.co.jp

completed

May. 12, 2016

Interventional

Open-label, single arm, phase II study

treatment purpose

2

Key inclusion criteria
- Provided written informed consent
- Histologically confirmed GIST.
- Have had previous treatments of imatinib, sunitinb and regorafenib
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

Key exclusion criteria
- A serious illness or medical condition
- Previous or concurrent cancer that is distinct in primary disease or histology from the cancer that is being evaluated in this study. (Cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (stage Ta, Tis and T1), cancers corresponding to intraepithelial or intramucosal neoplasia and any previous cancer curatively treated more than 5 years before the enrollment can be eligible.)
- Pregnant or lactating female (including the cessation of lactation) or females of child-bearing potential who have a positive pregnancy test proceeded during the Baseline Period.

Both

GIST

investigational material(s)
Generic name etc : TAS-116
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : The starting dose of TAS-116 will be 160 mg/body given orally, 5days on/2 days off in patients with GIST.

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

efficacy
Efficacy
RECIST(Ver.1.1)

safety
pharmacokinetics
pharmacogenomics
Safety, Pharmacokinetics, Pharmacogenomics
CTCAE(Ver.4.03)

May. 18, 2016