Advanced Malignant Solid NeoplasmPhase 3NCT05403580
Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Patients With Advanced Cancer
A Phase 3 study testing Olanzapine and Questionnaire Administration in people with Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, run by Mayo Clinic.
Trial summary
This phase III trial compares olanzapine to placebo in decreasing nausea and vomiting in patients with cancer that has spread to other places in the body (advanced). Patients with advanced cancer may experience nausea and/or vomiting that is unrelated to chemotherapy or radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm
- What is being tested?
- Olanzapine and Questionnaire Administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 3 Jun 2022to Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Age >= 18 years
- Histologically or cytologically-confirmed cancer in an advanced incurable stage
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- Chronic nausea that has been present for at least one week (daily score > 5, on a 0-10 visual analogue scale)
- Serum creatinine < 2.0 mg/dl =< 120 days prior to registration
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) values < 3 times upper limits of normal =< 120 days prior to registration
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- Negative pregnancy test done =< 14 days prior to registration, for persons of childbearing potential only
- Able to provide written informed consent
- Able to complete questionnaire(s) by themselves or with assistance
Who cannot join
- Any of the following because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects:
- Pregnant persons
- Nursing persons
- Received chemotherapy or radiation within the prior 14 days (advanced cancer patients receiving hormonal therapy or targeted therapy that does not come with a recommendation for prophylactic anti-emetic therapy are eligible)
- Receiving treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for =< 30 days prior to registration or planned during protocol therapy (patients may have received prochlorperazine and other phenothiazines as prior anti-emetic therapy)
- Those with concurrent use of ethyol; severe cognitive compromise; concurrent use of amifostine; concurrent use of quinolone antibiotic therapy; known hypersensitivity to olanzapine; or have planned chemotherapy or radiation during the 7 days following study initiation
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- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection (including human immunodeficiency virus [HIV])
- Cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
- Psychiatric illness/social situations that would limit compliance with study requirements
- Inability to swallow oral formulations of the agent(s)
- Tube feeding or nasogastric tube
About this study
Official title: Olanzapine for the Treatment of Chronic Nausea and/or Vomiting, Unrelated to Chemotherapy or Radiation, in Advanced Cancer Patients - A Confirmatory Phase III MNCCTN Trial
This phase III trial compares olanzapine to placebo in decreasing nausea and vomiting in patients with cancer that has spread to other places in the body (advanced). Patients with advanced cancer may experience nausea and/or vomiting that is unrelated to chemotherapy or radiation. Giving olanzapine may help reduce nausea and increase appetite in patients who have advanced cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To conduct a confirmatory phase III double-blind randomized clinical trial to evaluate the ability of olanzapine to decrease nausea in patients with advanced-cancer associated nausea/vomiting.
SECONDARY OBJECTIVES:
- To evaluate toxicity associated with olanzapine in patients with advanced-cancer associated nausea/vomiting.
II. To evaluate the effect of olanzapine on appetite, vomiting, sedation, sleep, the use of other antiemetic agents, fatigue, and well-being.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive olanzapine orally (PO) every night on days 1-28.
ARM II: Patients receive placebo PO every night on days 1-2 and olanzapine PO every night on days 3-28.
- Being tested
- Olanzapine, Placebo Administration, Questionnaire Administration
- Medical subject headings
- Hematologic Neoplasms
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) | Experimental | Patients receive olanzapine PO every night on days 1-28. Receives: Drug: Olanzapine; Other: Questionnaire Administration |
| Arm II (placebo, olanzapine) | Active comparator | Patients receive placebo PO every night on days 1-2 and olanzapine PO every night on days 3-28. Receives: Drug: Olanzapine; Drug: Placebo Administration; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nausea score
Evaluated using Visual Analogue Scale. Nausea scores at baseline and after the first two days and the change scores, for the first 2 days, will be summarized using mean (standard deviation) and median (range). The change scores from baseline to the end of the first 2 days will be compared between arms using a two-sample t-test or a Wilcoxon rank sum test as appropriate. The difference in nausea change scores from baseline to 2 days post treatment initiation between the two arms will be estimated along with a 95% confidence interval.
Measured: Baseline to 24 hours of treatment
Secondary outcomes (4)
Daily nausea and vomiting scores
Chronic nausea this is present for at least 1 week (worst daily nausea numeric rating scores needed to be greater than 3 on a 0-10 scale).
Measured: Up to 28 days
Daily episodes of vomiting/retching (number and time)
Chronic nausea that is present for at least 1 week (worst daily nausea numeric rating scores needed to be greater than 3 on a 0-10 scale).
Measured: Up to 28 days
Utilization of rescue therapy
Baseline evaluation that includes assessment of symptom intensity for appetite, nausea, fatigue, sedation, and pain, all measured and recorded on a numeric rating score. (0 indicated the worst possible; 10, best possible).
Measured: Up to 28 days
Incidence of adverse events with olanzapine
Measured by patient reported outcome questionnaires and Common Terminology Criteria for Adverse Events version 5.0.
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start3 Jun 2022
- Primary completion29 Dec 2023
- Study completionDec 2024 (estimated)
Why it stopped: Closed due to slow accrual
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 Mayo ClinicThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles L Loprinzi, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403580
- Sponsor's protocol ID
- MC211002
- Other IDs
- NCI-2022-02478, MC211002, 21-011317
- Status last verified
- May 2024
- First submitted
- 19 May 2022
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olanzapine for the Treatment of Chronic Nausea and/or Vomiting, Unrelated to Chemotherapy or Radiation, in Advanced Cancer Patients - A Confirmatory Phase III MNCCTN Trial
- ClinicalTrials.gov ID
- NCT05403580
- Acronym / sponsor ID
- MC211002
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Closed due to slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 3 Jun 2022 (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 III trial compares olanzapine to placebo in decreasing nausea and vomiting in patients with cancer that has spread to other places in the body (advanced). Patients with advanced cancer may experience nausea and/or vomiting that is unrelated to chemotherapy or radiation. Giving olanzapine may help reduce nausea and increase appetite in patients who have advanced cancer.
Detailed description
PRIMARY OBJECTIVE:
- To conduct a confirmatory phase III double-blind randomized clinical trial to evaluate the ability of olanzapine to decrease nausea in patients with advanced-cancer associated nausea/vomiting.
SECONDARY OBJECTIVES:
- To evaluate toxicity associated with olanzapine in patients with advanced-cancer associated nausea/vomiting.
II. To evaluate the effect of olanzapine on appetite, vomiting, sedation, sleep, the use of other antiemetic agents, fatigue, and well-being.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive olanzapine orally (PO) every night on days 1-28.
ARM II: Patients receive placebo PO every night on days 1-2 and olanzapine PO every night on days 3-28.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (olanzapine) | Experimental | Drug: Olanzapine, Other: Questionnaire AdministrationPatients receive olanzapine PO every night on days 1-28. |
| Arm II (placebo, olanzapine) | Active comparator | Drug: Olanzapine, Drug: Placebo Administration, Other: Questionnaire AdministrationPatients receive placebo PO every night on days 1-2 and olanzapine PO every night on days 3-28. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >= 18 years
- Histologically or cytologically-confirmed cancer in an advanced incurable stage
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- Chronic nausea that has been present for at least one week (daily score > 5, on a 0-10 visual analogue scale)
- Serum creatinine < 2.0 mg/dl =< 120 days prior to registration
Key exclusion criteria (12 listed)
- Any of the following because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects:
- Received chemotherapy or radiation within the prior 14 days (advanced cancer patients receiving hormonal therapy or targeted therapy that does not come with a recommendation for prophylactic anti-emetic therapy are eligible)
- Receiving treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for =< 30 days prior to registration or planned during protocol therapy (patients may have received prochlorperazine and other phenothiazines as prior anti-emetic therapy)
- Those with concurrent use of ethyol; severe cognitive compromise; concurrent use of amifostine; concurrent use of quinolone antibiotic therapy; known hypersensitivity to olanzapine; or have planned chemotherapy or radiation during the 7 days following study initiation
- Uncontrolled intercurrent illness including, but not limited to:
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), Arm II (placebo, olanzapine) |
| Placebo AdministrationGiven PO | Drug | Arm II (placebo, olanzapine) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (olanzapine), Arm II (placebo, olanzapine) |
Primary outcome
Change in nausea score
Time frame: Baseline to 24 hours of treatment
Evaluated using Visual Analogue Scale. Nausea scores at baseline and after the first two days and the change scores, for the first 2 days, will be summarized using mean (standard deviation) and median (range). The change scores from baseline to the end of the first 2 days will be compared between arms using a two-sample t-test or a Wilcoxon rank sum test as appropriate. The difference in nausea change scores from baseline to 2 days post treatment initiation between the two arms will be estimated along with a 95% confidence interval.
4 secondary outcomes
Daily nausea and vomiting scores
Time frame: Up to 28 days
Daily episodes of vomiting/retching (number and time)
Time frame: Up to 28 days
Utilization of rescue therapy
Time frame: Up to 28 days
Incidence of adverse events with olanzapine
Time frame: Up to 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Charles L Loprinzi principal investigator
Mayo Clinic in Rochester
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olanzapine and Questionnaire Administration in people with Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, run by Mayo Clinic.
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 9 inclusion and 12 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: withdrawn, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nausea score (time frame: Baseline to 24 hours of treatment). 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 6 May 2024.