Patients with non-small cell lung cancer, pancreatic cancer, or colorectal cancer with cancer cachex
Conditions
Interventions
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 s
Sponsors
Masuda Noriyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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) (b) Pancreatic cancer: standard first- or second-line systemic chemotherapy (c) Colorectal cancer: oxaliplatin-based systemic chemotherapy
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight changes from baseline | — |
Contacts
Public ContactKazuo Koba
Taiho Pharmaceutical Co., Ltd.
Outcome results
None listed