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Randomized Phase 2a Study of TAS0953 in Patients with Cancer Cachexia (Randomized Phase 2a Study of TAS0953 in Patients with Cancer Cachexia)

Phase 2a Study of TAS0953 for Cancer Cachexia (Phase 2a Study of TAS0953 for Cancer Cachexia)

Masuda Noriyuki

Kishiwada Tokushukai Hospital

4-27-1 Kamori-cho, Kishiwada-shi, Osaka

th-tas0953_cachexia_clinical@taiho.co.jp

Koba Kazuo

Taiho Pharmaceutical Co., Ltd.

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

+81-3-3294-4527

th-tas0953_cachexia_clinical@taiho.co.jp

Recruiting

Aug. 20, 2025

Interventional

randomized controlled trial

single blind

placebo control

parallel assignment

treatment purpose

1. Written informed consent to participate in this study has been obtained.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
3. Diagnosed with cancer cachexia according to Fearon criteria.
4. Persistent grade 1 or higher loss of appetite due to cancer cachexia (excluding patients whose decreased food intake is judged to be solely due to side effects of systemic chemotherapy, such as oral mucositis, nausea, vomiting, diarrhea, or constipation).
5. Histologically or cytologically confirmed diagnosis of unresectable or advanced non-small cell lung cancer, pancreatic cancer, or colorectal cancer.
6. Currently receiving the following systemic chemotherapy (neoadjuvant or adjuvant therapy is excluded):
(a) Non-small cell lung cancer: platinum-based systemic chemotherapy (immune checkpoint inhibitor [ICI] co-administration allowed), standard second-line systemic chemotherapy for patients previously treated with platinum-based systemic chemotherapy
(b) Pancreatic cancer: standard first-line systemic chemotherapy
(c) Colorectal cancer: oxaliplatin-based systemic chemotherapy, standard second-line systemic chemotherapy for patients previously treated with oxaliplatin-based systemic chemotherapy

1. Presence of ascites, pleural effusion, or pericardial effusion requiring therapeutic puncture, or uncontrolled edema within 14 days prior to enrollment.
2. Presence of organic gastrointestinal disorders that prevent oral intake.
3. Determined by the investigator to have cachexia due to reasons other than cancer.
4. BMI > 30 kg/m2.
5. Confirmed presence of RET fusion gene.
6. Interstitial lung disease/pneumonitis or drug-induced lung disease/pneumonitis, or history thereof

Both

Patients with non-small cell lung cancer, pancreatic cancer, or colorectal cancer with cancer cachex

The investigational drug administration will begin on the same day as randomization.
However, if the initial administration of the concomitant anticancer drug is postponed or canceled on the planned start date of TAS0953 administration, the start of TAS0953 administration will also be postponed until the anticancer drug treatment is initiated.
Patients will be assigned to TAS0953 groups (10 mg/day, 50 mg/day, 100 mg/day, 200 mg/day, 600 mg/day) or placebo group, and will receive the study drug at the dose and dosage for each group orally on an empty stomach (no food 2 hours before and 1 hour after administration of the study drug) with a glass of water. Patients are instructed to avoid other liquids (milk, fruit juice, etc.) and to swallow the tablets without chewing. Patients have no food for 2 hours before and 1 hour after administration of the study drug, but water intake is allowed. In the case of SID, it is administered approximately every 24 hours, and in the case of BID, approximately every 12 hours for 12 weeks. If patients meet the criteria for discontinuation of the study treatment, the administration will be stopped.

Body weight changes from baseline

+81-75-251-5111

No

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