Advanced Malignant Solid Neoplasm study: Olanzapine
Official title Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esophagogastric, Hepatopancreaticobiliary, Colorectal or Lung Cancer
ClinicalTrials.gov ID: NCT05705492
What this study is testing
What is Olanzapine?
An investigational oral medicine being studied as a potential treatment for cancer‑related cachexia and appetite loss. Olanzapine is designed to block dopamine and serotonin receptors, which may help stimulate appetite.
Also referred to as LY 170053, Zyprexa, Zyprexa Zydis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out whether olanzapine can improve appetite and reduce weight loss in people with advanced solid tumors who are losing appetite during treatment.
- Who it's for
- Adults with advanced or metastatic esophageal, gastric, hepatopancreaticobiliary, colorectal, or lung cancer who have loss of appetite while receiving non‑curative therapy.
- What's involved
- Participants will take olanzapine and have regular clinic visits for safety checks, appetite questionnaires, and weight measurements.
- Time commitment
- The trial lasts several weeks to months, with visits scheduled periodically throughout the treatment period.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Willingness to provide written informed consent
- Individuals \>= 18 years of age
- Histologically confirmed advanced local or metastatic esophogastric, hepatopancreaticobiliary, colorectal, or lung cancer diagnosis within 12 weeks...
- ≥ 5% weight loss over the past 6 months
- ≥ 2% weight loss with body mass index (BMI) \<20 kg/m\^2 or sarcopenia
You likely can't join if
- Plan for, or history of (within 30 days of enrollment), the use of an antipsychotic drug, including, but not limited to, risperidone, quetiapine...
- 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...
- Known history of poorly controlled diabetes, defined as fasting morning blood sugars ≥300 mg/dL or recent hemoglobin A1≥ 8.
- Total bilirubin ≥5x upper limit of normal (ULN), aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine...
See the full eligibility criteria
- Willingness to provide written informed consent
- Individuals \>= 18 years of age
- Histologically confirmed advanced local or metastatic esophogastric, hepatopancreaticobiliary, colorectal, or lung cancer diagnosis within 12 weeks of screening
- ≥ 5% weight loss over the past 6 months
- ≥ 2% weight loss with body mass index (BMI) \<20 kg/m\^2 or sarcopenia
- Planned or ongoing first-line palliative antineoplastic therapy (cytotoxic chemotherapy, targeted therapy, immunotherapy, combinations) with or without radiation therapy and have not started the second cycle of...
- Able to ambulate independently with or without assistive devices (e.g., cane, walker)
- In the case of brain metastases, the individual must be asymptomatic or previously treated with a full cycle of therapy with recovery from any acute effects of radiation therapy or surgery before screening.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Able and willing to discontinue the use of any drug or over-the-counter (OTC) product that may interact with the study drug (within a period sufficient for wash-out per the principal investigators [PI's] discretion) and...
- Willingness to comply with restrictions on chest/breastfeeding
- Individuals capable of childbearing and contributing viable sperm must be willing to comply with contraception requirements and not donate ova or sperm while on the study and for 1 month after that
- A negative pregnancy test at baseline (BL) must be obtained for individuals capable of childbearing
- 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.
- 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
- Known history of poorly controlled diabetes, defined as fasting morning blood sugars ≥300 mg/dL or recent hemoglobin A1≥ 8.
- Total bilirubin ≥5x upper limit of normal (ULN), aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SPGT]) ≥5X ULN...
- Primary investigator (PI) discretion will determine continued eligibility after randomization occurs in the event the liver function test results are above the proposed ULN
- Renal disease requiring dialysis or calculated glomerular filtration rate (GFR) ≤ 30 mL/minute/1.73 m\^2 as calculated by the modification of diet in renal disease (MDRD) equation
- Tube feeding or parenteral nutrition at the time of screening
- Any condition that may negatively impact oral absorption of the study drug (including, but not limited to dysphagia, mucositis, gastrectomy, colitis, bowel obstruction, high output ileostomy) or any plan to undergo an...
- Recurrent ascites unresponsive to medical interventions and requires therapeutic paracentesis
- Uncontrolled symptoms at randomization make the individual unsuitable for the study in the judgment of the PI.
- Uncontrolled infection, including coronavirus disease 2019 (COVID-19), at time of randomization. Individuals with the uncontrolled infection will not be eligible as the symptomology of infection may obscure the outcomes...
- Other medical or psychiatric condition, including recent (within 1 year) or active suicidal ideation/behavior or laboratory abnormality, may increase the risk of study participation or, in the PI's judgment, makes the...
The study team makes the final eligibility decision.
Where it is enrolling
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Portland, Oregon, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.