Anamorelin study for gastrectomized patients with unresectable advanced or recurrent gastric cancer

JRCT ID: jRCTs051210108

Registered date:13/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Unresectable advanced or recurrent gastric cancer and cachexia
• Date of first enrollment: 17/11/2021
• Target sample size: 200
• Study type: Interventional
• Intervention(s): Administration of anamorelin for unresectable advanced or recurrent gastric cancer

Outcome(s)

• Primary Outcome: Changes of lean body mass

Secondary Outcome

1. Transition of lean body mass
2. Change in body weight
3. Transition of body weight
4. Body composition (Fat mass)
5. Transition of body composition (Fat mass)
6. Skeletal muscle index (SMI)
7. Transition of Cancer fatigue scale
8. Grip strength
9. Transition of grip strength
10. Relative Dose Intensity of chemotherapy
11. Change of QOL-ACD score
12. Transition of QOL-ACD score
13. Blood examinations for assessment of nutritional states
14. CTCAE grade of 3 items related with chemotherapy-induced adverse events: anorexia, nausea, vomiting
15. Chemotherapy response judged by RECIST ver1.1

Key inclusion & exclusion criteria

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

Include criteria

(1) Recurrent gastric cancer over 3 months after gastrectomy or unrectable advanced gastric cancer
(2) Planning a new line of 1st-3rd chemotherapy or receiving 1st-3rd chemotherapy
(3) Involuntary weight loss of >=5% observed within the previous 6 months
(4) Fulfilling at least 2 items of following criteria
1. Fatigue
2. Decreased general muscle strength
3. Fulfilling at least one item of following criteria
i. CRP>0.5mg/dL
ii. Hb<12g/dL
iii. Alb<3.2g/dL
(5) Aged>=20 years at the time of informed consent
(6) Life expectancy >= 4 months from the time of informed consent
(7) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
(8) Adequate organ (Bone marrow, hepatic, renal) function
1. WBC: >=2,500/mm3, <12,000/mm3
2. Plt: >=10x104/mm3
3. Hb: >=8g/dL
4. AST (GOT): <=150U/L
5. ALT (GPT): <=180U/L
6. Cre: <=2.0mg/dL
(9) with written informed consent

Exclude criteria

(1) Previous history of administration of anamorelin
(2) Previous history of allergy for ingredients of anamorelin
(3) Previous history of congestive heart failure
(4) Myocarical infarction or cardica angina
(5) Severe dysfunction of impulse conducting system (complete AV block etc.)
(6) Taking prescription medications with: Clarithromycin, Indinavir, Itraconazole, Nelfinavir, Saquinavir, Telaprevir, Voriconazole, Ritonavir, Cobicistat
(7) Moderate liver dysfunction (Child-Pugh classification B or C)
(8) Inability of taking orally due to bowel abnormality (e.g., bowel obstruction)
(9) Poor control of diabetes mellitus
(10) Pregnant or possibility of pregnancy
(11) Active synchronous or metachronous malignancies (excluding carcinoma in situ)
(12) Self-contained mechanical device such as pacemaker
(13) Judged by doctors as inadequate

Related Information

• Primary Sponsor: Doki Yuichiro
• Source(s) of Monetary Support: Ono Pharmaceutical Co., Ltd.