Advanced Malignant Solid NeoplasmPhase 2NCT05705492
Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esophagogastric, Hepatopancreaticobiliary, Colorectal or Lung Cancer
A Phase 2 study testing Olanzapine and Questionnaire Administration in people with Advanced Malignant Solid Neoplasm and Advanced Biliary Tract Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Neoplasm, Advanced Biliary Tract Carcinoma, Advanced Esophageal Carcinoma
- What is being tested?
- Olanzapine and Questionnaire Administration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2024to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Patients with weight loss as defined by international consensus criteria (documented or patient-reported):
- ≥ 5% weight loss over the past 6 months
- ≥ 2% weight loss with body mass index (BMI) <20 kg/m^2 or sarcopenia
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- 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 first-line palliative antineoplastic therapy. Patients may have received adjuvant antineoplastic therapy at least 6 months prior to screening
- 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. Such individuals must have discontinued corticosteroid treatment and be neurologically stable for at least 4 weeks 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 thereafter while on the study
- 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
Who cannot join
- 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. The use of antipsychotics concurrent with protocol therapy will not be allowed
- 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
- Known history of poorly controlled diabetes, defined as fasting morning blood sugars ≥300 mg/dL or recent hemoglobin A1≥ 8. Individuals with diabetes will undergo hemoglobin A1c (HbA1c) blood testing if they do not have HbA1c results 12 weeks prior to enrollment
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- Inadequate organ function, which may include, but is not limited to, the following laboratory results within 28 days before signing consent:
- 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 (unless the participant has documented Gilbert's syndrome, hepatocellular carcinoma, or hepatic metastases)
- 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 intervention that will render such a condition
- 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. If uncontrolled symptoms can be effectively palliated for ≥1 week prior, enrollment may be considered at the discretion 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 of this study
- 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 participant inappropriate for the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Eric Roeland, M.D., FAAHPM, FASCO, 503-494-8534, roeland@ohsu.edu
Eric Roeland, M.D., FAAHPM, FASCO
About this study
Official title: ACTO: A Phase II, Randomized, Placebo-Controlled Study Evaluating Olanzapine in the Management of Cancer Cachexia
This 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).
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the impact of olanzapine 2.5 mg versus (vs) placebo on the proportion of patients with locally advanced or metastatic EG, HPB, or lung cancers receiving first-line systemic standard-of-care (SOC) therapy with >5% weight gain over 12 weeks. (Part A)
SECONDARY OBJECTIVE:
- To evaluate the impact of olanzapine 2.5 mg and placebo vs olanzapine 5 mg on the proportion of patients with >5% weight gain over 12 weeks. (Part A) II. To evaluate the impact of olanzapine 2.5 mg vs olanzapine 5 mg vs placebo on additional cancer cachexia-associated endpoints over 12 weeks (anorexia, nutritional status, physical function, patient-reported symptoms, QOL, safety and toxicity, and healthcare utilization) over 12 weeks. (Part A)
OUTLINE:
PART A: Patients are randomized to 1 of 3 arms. All three arms have an optional baseline computed tomography (CT) scan (timed with standard-of-care imaging) at baseline and optional monthly blood sample collections.
ARM I: Patients receive a lower (2.5 mg) dose of olanzapine orally (PO) nightly for 12 weeks in the absence of unacceptable toxicity. Patients may choose to enroll in an additional 12 weeks of treatment (Part B). Patients may choose to participate to undergo CT scan and collection of blood samples on study.
ARM II: Patients receive a higher (5 mg) dose of olanzapine PO nightly for 12 weeks in the absence of unacceptable toxicity. Patients may choose to enroll in an additional 12 weeks of treatment. Patients may choose to participate to undergo CT scan and collection of blood samples on study.
ARM III: Patients receive placebo PO nightly for 12 weeks in the absence of unacceptable toxicity. Patients may choose to enroll in an additional 12 weeks of treatment. Patients may choose to participate to undergo CT scan and collection of blood samples on study.
PART B: All patients receive a lower (2.5mg) dose of olanzapine PO nightly for 12 additional weeks in the absence of unacceptable toxicity. Patients may choose to participate in additional blood sample collections.
After completion of study treatment, patients are followed up at 1 week.
- Conditions
- Advanced Malignant Solid Neoplasm, Advanced Biliary Tract Carcinoma, Advanced Esophageal Carcinoma, Metastatic Esophageal Carcinoma, Locally Advanced Colorectal Carcinoma, Locally Advanced Esophageal Carcinoma
- Being tested
- Olanzapine, Placebo Administration, Questionnaire Administration
- Keywords
- cancer, cachexia, weight loss, loss of appetite
- Medical subject headings
- Esophageal Neoplasms, Colorectal Neoplasms, Neoplasms, Cachexia, Weight Loss, Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Also called LY 170053, Zyprexa, Zyprexa Zydis
Given PO
Placebo AdministrationDrug
Given PO
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (olanzapine, optional biospecimen collection) | Experimental | Patients receive a lower (2.5mg) dose of olanzapine orally (PO) nightly for 12 weeks in the absence of unacceptable toxicity. Patients may choose to enroll in an additional 12 weeks of treatment. Patients can choose to undergo computed tomography (CT) scan at baseline and monthly blood sample collections on study. Receives: Drug: Olanzapine; Other: Questionnaire Administration |
| Arm II | Experimental | Patients receive a higher dose (5 mg) of olanzapine PO nightly for 12 weeks in the absence of unacceptable toxicity. Patients may choose to enroll in an additional 12 weeks of treatment. Patients undergo an optional baseline CT scan and collections of monthly blood samples on study. Receives: Drug: Olanzapine; Other: Questionnaire Administration |
| Arm III | Placebo comparator | ARM III: Patients receive placebo PO nightly for 12 weeks in the absence of unacceptable toxicity. Patients may choose to enroll in an additional 12 weeks of treatment. Patients undergo CT scan and monthly collection of blood samples on study. Receives: Drug: Placebo Administration; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients exhibiting weight gain greater 5%
>5% weight gain comparing olanzapine 2.5mg (Arm I) vs. placebo (Arm III)
Measured: Baseline to 12 weeks from baseline
Secondary outcomes (14)
Change in Weight
>5% weight gain comparing olanzapine 2.5 mg (Arm I) vs. olanzapine 5mg (Arm II)
>5% weight gain comparing olanzapine 5 mg (Arm II) vs. placebo (Arm III)
Measured: Baseline to 12 weeks from baseline
Anorexia
Patient reported anorexia comparing olanzapine 2.5 mg (Arm 1) vs. olanzapine 5 mg (Arm 2) vs. placebo (Arm 3) Anorexia will be measured using the Functional Assessment of Anorexia-Cachexia Therapy (FAACT), a 12-item subscale of patients' perceptions of appetite (maximum score of 48, higher scores indicate less anorexia). A FAACT score ≤ 37 indicates anorexia.
Measured: At 12 weeks from baseline]
Appetite
Change in appetite will be measured using the Visual Analog Scale for appetite (VAS), a 10-point scale with a higher score indicating a better appetite. A ≥3-point improvement in appetite at the end of the 12-week placebo-controlled Part A as compared to baseline in each arm will be considered an improvement in appetite.
Measured: Baseline up to 12 weeks from baseline
Nutrition
Nutritional Status will be measured using the Patient- Generated Subjective Assessment Short Form (PG-SGA-SF); scored on a scale of 0-36 with a higher score indicating worse malnutrition.
Measured: At baseline and at 4, 8, 12 weeks from baseline
Physical Function
Eastern Cooperative Oncology Group (ECOG) Performance Status is a clinician's assessment of physical function rated 0 to 5 with a lower score indicating better performance.
Measured: At baseline and at 4, 8, and12 weeks from baseline
Physical Function
Karnofsky Performance Scale (KPS) is a clinician assessed score (0-100) to evaluate physical function and ability to carry out daily activities. A higher score indicates better performance. [Time Frame: At baseline and at 4, 8, 12 weeks from baseline]
Measured: At baseline and at 4, 8, and12 weeks from baseline
Physical Function
Tthe Short Physical Performance Battery (SPPB) is a physical function assessment consisting of 3 timed measures and scored 0 to 12 with a higher score indicating better performance.
Measured: At baseline and at 4, 8, and12 weeks from baseline
Patient Reported Quality of Life
Patient reported quality of life will be measured using the Functional Assessment of Cancer Therapy - General (FACT-G,) consisting of four domains (physical, social, emotional, and functional) of well-being with scores ranging from 0 to 108 with higher scores indicating better QOL.
Measured: Baseline to 12 weeks from baseline
Patient-reported impression of change
Patient Global Impression of Change (PGI-C) is a 7-point scale depicting a patient's rating of overall improvement in appetite and fatigue with a higher score indicating more improvement .
Measured: At 12 weeks from baseline
Patient Reported Symptoms
Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) will be used to capture symptoms associated with cancer cachexia and/or its treatment. Each response is scored from 0-4 with a higher score indicating more severity.
Measured: At 4, 8, and 12 weeks from baseline
Incidence of adverse events
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.
Measured: At 4, 8, and 12 weeks from baseline
Proportion of patients with ≥1 unplanned hospitalization
Calculation and analysis of patients who have 1 or more unplanned hospitalization.
Measured: At baseline and at 4, 8, and 12 weeks from baseline
Proportion of patients with ≥1 emergency department visit
Health care utilization including emergency department visits, hospital admissions.
Measured: At baseline and at 4, 8, and 12 weeks from baseline
Proportion of patients with ≥1 unplanned hospitalization
Number of unplanned hospitalizations
Measured: From baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start17 Jul 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Roeland, M.D.,FASCO, FAAHPM, OHSU Knight Cancer Institute
- Investigators
- Eric Roeland, M.D., FAAHPM, FASCO, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705492
- Sponsor's protocol ID
- STUDY00024724
- Other IDs
- P30CA069533, NCI-2022-10209, STUDY00024724
- Status last verified
- Jul 2026
- First submitted
- 6 Jan 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACTO: A Phase II, Randomized, Placebo-Controlled Study Evaluating Olanzapine in the Management of Cancer Cachexia
- ClinicalTrials.gov ID
- NCT05705492
- Acronym / sponsor ID
- STUDY00024724
- Conditions
- Advanced Malignant Solid Neoplasm, Advanced Biliary Tract Carcinoma, Advanced Esophageal Carcinoma, Metastatic Esophageal Carcinoma, Locally Advanced Colorectal Carcinoma, Locally Advanced Esophageal Carcinoma
- Keywords
- cancer, cachexia, weight loss, loss of appetite
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, National Cancer Institute (NCI)
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 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).
Detailed description
PRIMARY OBJECTIVE:
- To assess the impact of olanzapine 2.5 mg versus (vs) placebo on the proportion of patients with locally advanced or metastatic EG, HPB, or lung cancers receiving first-line systemic standard-of-care (SOC) therapy with >5% weight gain over 12 weeks. (Part A)
SECONDARY OBJECTIVE:
- To evaluate the impact of olanzapine 2.5 mg and placebo vs olanzapine 5 mg on the proportion of patients with >5% weight gain over 12 weeks. (Part A) II. To evaluate the impact of olanzapine 2.5 mg vs olanzapine 5 mg vs placebo on additional cancer cachexia-associated endpoints over 12 weeks (anorexia, nutritional status, physical function, patient-reported symptoms, QOL, safety and toxicity, and healthcare utilization) over 12 weeks. (Part A)
OUTLINE:
PART A: Patients are randomized to 1 of 3 arms. All three arms have an optional baseline computed tomography (CT) scan (timed with standard-of-care imaging) at baseline and optional monthly blood sample collections.
ARM I: Patients receive a lower (2.5 mg) dose of olanzapine orally (PO) nightly for 12 weeks in the absence of unacceptable toxicity. Patients may choose to enroll in an additional 12 weeks of treatment (Part B). Patients may choose to participate to undergo CT scan and collection of blood samples on study.
ARM II: Patients receive a higher (5 mg) dose of olanzapine PO nightly for 12 weeks in the absence of unacceptable toxicity. Patients may choose to enroll in an additional 12 weeks of treatment. Patients may choose to participate to undergo CT scan and collection of blood samples on study.
ARM III: Patients receive placebo PO nightly for 12 weeks in the absence of unacceptable toxicity. Patients may choose to enroll in an additional 12 weeks of treatment. Patients may choose to participate to undergo CT scan and collection of blood samples on study.
PART B: All patients receive a lower (2.5mg) dose of olanzapine PO nightly for 12 additional weeks in the absence of unacceptable toxicity. Patients may choose to participate in additional blood sample collections.
After completion of study treatment, patients are followed up at 1 week.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (olanzapine, optional biospecimen collection) | Experimental | Drug: Olanzapine, Other: Questionnaire AdministrationPatients receive a lower (2.5mg) dose of olanzapine orally (PO) nightly for 12 weeks in the absence of unacceptable toxicity. Patients may choose to enroll in an additional 12 weeks of treatment. Patients can choose to undergo computed tomography (CT) scan at baseline and monthly blood sample collections on study. |
| Arm II | Experimental | Drug: Olanzapine, Other: Questionnaire AdministrationPatients receive a higher dose (5 mg) of olanzapine PO nightly for 12 weeks in the absence of unacceptable toxicity. Patients may choose to enroll in an additional 12 weeks of treatment. Patients undergo an optional baseline CT scan and collections of monthly blood samples on study. |
| Arm III | Placebo comparator | Drug: Placebo Administration, Other: Questionnaire AdministrationARM III: Patients receive placebo PO nightly for 12 weeks in the absence of unacceptable toxicity. Patients may choose to enroll in an additional 12 weeks of treatment. Patients undergo CT scan and monthly collection of blood samples on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
- Patients with weight loss as defined by international consensus criteria (documented or patient-reported):
- 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 first-line palliative antineoplastic therapy. Patients may have received adjuvant antineoplastic therapy at least 6 months prior to screening
Key exclusion criteria (16 listed)
- 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. The use of antipsychotics concurrent with protocol therapy will not be allowed
- Current use of medications or supplements with the goal of enhancing appetite within ≥14 days, including:
- Known history of poorly controlled diabetes, defined as fasting morning blood sugars ≥300 mg/dL or recent hemoglobin A1≥ 8. Individuals with diabetes will undergo hemoglobin A1c (HbA1c) blood testing if they do not have HbA1c results 12 weeks prior to enrollment
- Inadequate organ function, which may include, but is not limited to, the following laboratory results within 28 days before signing consent:
- Tube feeding or parenteral nutrition at the time of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlanzapineAlso: LY 170053, Zyprexa, Zyprexa ZydisGiven PO | Drug | Arm I (olanzapine, optional biospecimen collection), Arm II |
| Placebo AdministrationGiven PO | Drug | Arm III |
| Questionnaire AdministrationAncillary studies | Other | Arm I (olanzapine, optional biospecimen collection), Arm II, Arm III |
Primary outcome
Proportion of patients exhibiting weight gain greater 5%
Time frame: Baseline to 12 weeks from baseline
>5% weight gain comparing olanzapine 2.5mg (Arm I) vs. placebo (Arm III)
14 secondary outcomes
Change in Weight
Time frame: Baseline to 12 weeks from baseline
Anorexia
Time frame: At 12 weeks from baseline]
Appetite
Time frame: Baseline up to 12 weeks from baseline
Nutrition
Time frame: At baseline and at 4, 8, 12 weeks from baseline
Physical Function
Time frame: At baseline and at 4, 8, and12 weeks from baseline
Physical Function
Time frame: At baseline and at 4, 8, and12 weeks from baseline
Physical Function
Time frame: At baseline and at 4, 8, and12 weeks from baseline
Patient Reported Quality of Life
Time frame: Baseline to 12 weeks from baseline
Patient-reported impression of change
Time frame: At 12 weeks from baseline
Patient Reported Symptoms
Time frame: At 4, 8, and 12 weeks from baseline
Incidence of adverse events
Time frame: At 4, 8, and 12 weeks from baseline
Proportion of patients with ≥1 unplanned hospitalization
Time frame: At baseline and at 4, 8, and 12 weeks from baseline
Proportion of patients with ≥1 emergency department visit
Time frame: At baseline and at 4, 8, and 12 weeks from baseline
Proportion of patients with ≥1 unplanned hospitalization
Time frame: From baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Roeland, M.D., FAAHPM, FASCO principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olanzapine and Questionnaire Administration in people with Advanced Malignant Solid Neoplasm and Advanced Biliary Tract Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients exhibiting weight gain greater 5% (time frame: Baseline to 12 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.