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OncoMatch/Clinical Trials/NCT05705492

Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esophagogastric, Hepatopancreaticobiliary, Colorectal or Lung Cancer

Is NCT05705492 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Olanzapine for advanced malignant solid neoplasm.

Phase 2RecruitingOHSU Knight Cancer InstituteNCT05705492Data as of May 2026

Treatment: OlanzapineThis phase II trial tests how well olanzapine works in managing cancer cachexia in patients experiencing esophagogastric, hepatopancreaticobiliary, colorectal, or lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) -associated appetite loss while receiving non-curative cancer therapy. Loss of appetite ("anorexia") in the setting of cancer is a key feature of "cachexia," a syndrome associated with loss of weight and muscle as well as weakness and fatigue. Olanzapine is a drug that targets key neurotransmitters (a type of molecule in the central nervous system that transmits messages to the rest of the body) that may stimulate appetite, restore caloric intake, minimize weight loss, and improve quality of life (QOL).

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Esophageal Carcinoma

Colorectal Cancer

Gastric Cancer

Non-Small Cell Lung Carcinoma

Hepatocellular Carcinoma

Disease stage

Required: Stage III, IV

Histologically confirmed advanced local or metastatic esophogastric, hepatopancreaticobiliary, colorectal, or lung cancer

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: antipsychotic (risperidone, quetiapine, clozapine, phenothiazine, butyrophenone)

Exception: prochlorperazine and other phenothiazines as antiemetic therapy

Plan for, or history of (within 30 days of enrollment), the use of an antipsychotic drug, including, but not limited to, risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone. This limitation does not include prochlorperazine and other phenothiazines as antiemetic therapy.

Cannot have received: appetite stimulant (megestrol acetate, cannabinoids, dronabinol, medical cannabis, OTC cannabinoid products, corticosteroids)

Exception: corticosteroids allowed for standard-of-care chemotherapy-induced nausea and vomiting prophylaxis

Current use of medications or supplements with the goal of enhancing appetite within ≥14 days, including: megestrol acetate, cannabinoids (including, but not limited to dronabinol, medical cannabis, over the counter [OTC] cannabinoid products), and/or Corticosteroids (defined as ≥ 5mg of prednisone [or equivalent per day]), except for standard-of-care chemotherapy-induced nausea and vomiting prophylaxis

Lab requirements

Kidney function

Renal disease requiring dialysis or calculated GFR ≤ 30 mL/minute/1.73 m^2 (MDRD equation)

Liver function

Total bilirubin ≥5x ULN, AST and ALT ≥5X ULN (unless the participant has documented Gilbert's syndrome, hepatocellular carcinoma, or hepatic metastases); PI discretion for eligibility if above ULN

Inadequate organ function, which may include, but is not limited to, the following laboratory results within 28 days before signing consent: Total bilirubin ≥5x ULN, AST and ALT ≥5X ULN (unless the participant has documented Gilbert's syndrome, hepatocellular carcinoma, or hepatic metastases); PI discretion for eligibility if above ULN; Renal disease requiring dialysis or calculated GFR ≤ 30 mL/minute/1.73 m^2 (MDRD equation)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • OHSU Knight Cancer Institute · Portland, Oregon

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