CancerPhase 2NCT02400866
A Randomized Study of Olanzapine for the Prevention of CINV in Patients Receiving Moderately Emetogenic Chemotherapy
A Phase 2 study testing Olanzapine in people with Cancer, run by Korean South West Oncology Group.
Trial summary
This aim of study is to evaluate the safety and efficacy of olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy by a randomized, double-blind, placebo-controlled trial. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Olanzapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Apr 2017
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 19 years of age
- no history of receiving moderately or highly emetogenic chemotherapy during last 6 months, and is to receive a first course of MEC including one or more of following agents: Carboplatin, Cyclophosphamide ≤ 1,500 mg/m2, Daunorubicin, Doxorubicin < 60 mg/m2, Epirubicin ≤ 90 mg/m2, Irinotecan, Oxaliplatin, Melphalan, Methotrexate ≥ 250 mg/m2
- ECOG performance status 0-2
- predicted life expectancy ≥ 3 months
- adequate bone marrow, kidney, and liver functionas evidenced by: ANC ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, total bilirubine ≤ 2 x ULN, AST ≤ 3 x ULN, ALT ≤ 3 x ULN (for subjects with known liver metastases, total bilirubin ≤ 3 x ULN, AST ≤ 5 x ULN, ALT ≤ 5 x ULN), Creatinine ≤ 1.5 x ULN or Ccr ≥ 50 ml/min
- no episodes of nausea and vomiting during last 24 hours before enrollment
- subjects provides written informed consent
Who cannot join
- subjects with uncontrolled neuro-psychiatric disease (alcohol abuse, seizure, psychosis etc) except malignant tumor
- subject is scheduled to receive highly emetogenic chemotherapeutic agents: Doxorubicin or Epirubicin + cyclophosphamide, Cisplatin ≥ 50 mg/m2, Carmustine > 250 mg/m2, Cisplatin ≥ 50 mg/m2, Cyclophosphamide > 1,500 mg/m2, Dacarbazine, Doxurubicine ≥ 60 mg/m2, Epirubicine > 90 mg/m2, Ifosfamide ≥ 2 g/m2 per dose, Mechlorethamine, Streptozocin
- contraindication to the administration of palonosetron, dexamethasone, and olanzapine due to hypersensitivity or any other reasons
- subject has severe cognitive impairment
- subjects has symptomatic or uncontrolled brain metastasis or brain tumor
- female subjects of childbearing potential who dose not agree to use a proper contraceptive methods or to limit breast feeding
Show all 11Show fewer
- subject has taken the following agents: risperidone, quetiapine, clozapine, phenothiazine, butyrophenone, 5-HT3 antagonist, bezamides, domperidone, cannabinoids, NK1 antagonist, bezodiazepines
- subject has a plan to receive other chemotherapy, abdomial radiation, surgery, or immunotherapy
- any history of arrhythmia, uncontrolled congestive heart failure, acute myocardial infarction durting last 6 months
- history of uncontrolled diabetes
- subject who has used any investigational drugs within 30 days of randomization
Trial locations and contacts
No sites are listed yet.
About this study
This aim of study is to evaluate the safety and efficacy of olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy by a randomized, double-blind, placebo-controlled trial.
- Conditions
- Cancer
- Being tested
- Olanzapine
- Keywords
- cancer patients receiving moderately emetogenic chemotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | palonosetron + dexamethasone + placebo |
| Experimental | Experimental | palonosetron + dexamethasone + olanzapine Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response rate for the acute phase (0-24 hours) after chemotherapy
Measured: during 24 hours after first cycle of moderately emetogenic chemotherapy (MEC)
Secondary outcomes (5)
complete response rate for the delayed phase (24-120 hours) and overall phase (0-120 hours) after chemotherapy
Measured: during 0-120 hours after first cycle of MEC
no vomiting for the overall phase
Measured: during 0-120 hours after first cycle of MEC
significant emesis for the overall phase
Measured: during 0-120 hours after first cycle of MEC
numbers and time for rescue medicaions
Measured: during 0-120 hours after first cycle of MEC
effects on quality of life by FLIE questionnaire
Measured: during 0-120 hours after first cycle of MEC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2015 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korean South West Oncology Group
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Hwan Jung Yun, Korean South West Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400866
- Sponsor's protocol ID
- KSWOG 15-01
- Status last verified
- Mar 2015
- First submitted
- 24 Mar 2015
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Olanzapine for the Prevention of CINV in Patients Receiving Moderately Emetogenic Chemotherapy
- ClinicalTrials.gov ID
- NCT02400866
- Acronym / sponsor ID
- KSWOG 15-01
- Conditions
- Cancer
- Keywords
- cancer patients receiving moderately emetogenic chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Korean South West Oncology GroupResearch network
- Study start
- May 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 27 Mar 2015 (estimated)
- 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 aim of study is to evaluate the safety and efficacy of olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy by a randomized, double-blind, placebo-controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | –palonosetron + dexamethasone + placebo |
| Experimental | Experimental | Drug: Olanzapinepalonosetron + dexamethasone + olanzapine |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- over 19 years of age
- no history of receiving moderately or highly emetogenic chemotherapy during last 6 months, and is to receive a first course of MEC including one or more of following agents: Carboplatin, Cyclophosphamide ≤ 1,500 mg/m2, Daunorubicin, Doxorubicin < 60 mg/m2, Epirubicin ≤ 90 mg/m2, Irinotecan, Oxaliplatin, Melphalan, Methotrexate ≥ 250 mg/m2
- ECOG performance status 0-2
- predicted life expectancy ≥ 3 months
- adequate bone marrow, kidney, and liver functionas evidenced by: ANC ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, total bilirubine ≤ 2 x ULN, AST ≤ 3 x ULN, ALT ≤ 3 x ULN (for subjects with known liver metastases, total bilirubin ≤ 3 x ULN, AST ≤ 5 x ULN, ALT ≤ 5 x ULN), Creatinine ≤ 1.5 x ULN or Ccr ≥ 50 ml/min
Key exclusion criteria (11 listed)
- subjects with uncontrolled neuro-psychiatric disease (alcohol abuse, seizure, psychosis etc) except malignant tumor
- subject is scheduled to receive highly emetogenic chemotherapeutic agents: Doxorubicin or Epirubicin + cyclophosphamide, Cisplatin ≥ 50 mg/m2, Carmustine > 250 mg/m2, Cisplatin ≥ 50 mg/m2, Cyclophosphamide > 1,500 mg/m2, Dacarbazine, Doxurubicine ≥ 60 mg/m2, Epirubicine > 90 mg/m2, Ifosfamide ≥ 2 g/m2 per dose, Mechlorethamine, Streptozocin
- contraindication to the administration of palonosetron, dexamethasone, and olanzapine due to hypersensitivity or any other reasons
- subject has severe cognitive impairment
- subjects has symptomatic or uncontrolled brain metastasis or brain tumor
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 |
|---|---|---|
| Olanzapine | Drug | Experimental |
Primary outcome
complete response rate for the acute phase (0-24 hours) after chemotherapy
Time frame: during 24 hours after first cycle of moderately emetogenic chemotherapy (MEC)
5 secondary outcomes
complete response rate for the delayed phase (24-120 hours) and overall phase (0-120 hours) after chemotherapy
Time frame: during 0-120 hours after first cycle of MEC
no vomiting for the overall phase
Time frame: during 0-120 hours after first cycle of MEC
significant emesis for the overall phase
Time frame: during 0-120 hours after first cycle of MEC
numbers and time for rescue medicaions
Time frame: during 0-120 hours after first cycle of MEC
effects on quality of life by FLIE questionnaire
Time frame: during 0-120 hours after first cycle of MEC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olanzapine in people with Cancer, run by Korean South West Oncology Group.
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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 27 Mar 2015. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jooyoung Lee (82-42-280-7399, poppoya99@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response rate for the acute phase (0-24 hours) after chemotherapy (time frame: during 24 hours after first cycle of moderately emetogenic chemotherapy (MEC)). 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 27 Mar 2015.