EmesisPhase 2OlaCINVNCT03478605
Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis
A Phase 2 study testing Olanzapine, Aprepitant Pill and Ondansetron in people with Emesis and Vomiting, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
Trial summary
Olanzapine-containing regimens for CINV prophylaxis may provide even better protection than aprepitant-containing regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emesis, Vomiting, Nausea Post Chemotherapy
- What is being tested?
- Olanzapine, Aprepitant Pill and Ondansetron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteRussia
- Study dates
- 25 May 2018to 1 Jun 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High-emetogenic chemotherapy (HEC) regimen (e.g., cisplatin ≥70 mg/m2 or doxorubicin ≥60 mg/m2 or carboplatin AUC≥4). Patients that are prescribed less doses of mentioned agents are still allowed if another high-emetogenic drug will be administered (eg, doxorubicin plus cisplatin);
- Administration of HEC component only in first day of the cycle;
- No previous chemotherapy or radiotherapy;
- No concomitant quinolone antibiotics administration;
- ECOG PS ≤2;
- No nausea and vomiting 24 hours before enrollment;
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- Adequate hepatic and renal function (eg, ALaT, ASaT ≤3 ULN, creatinine clearance ≥50 ml/minute).
- No brain metastases, leptomeningeal carcinomatosis, and chronic diseases such as uncontrolled diabetes mellitus and chronic alcohol consumption.
- Subject willing to participate in the trial and provided informed consent form.
Who cannot join
- Previous chemotherapy or radiotherapy;
- Moderate- or low- emetogenic chemotherapy;
- Multiday administration of HEC agents;
- ECOG PS >2;
- History of brain metastases, signs of symptoms of bowel obstruction;
- Nausea and/or vomiting of any genesis 24 hours before enrollment;
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- Uncontrolled diabetes mellitus or other metabolic diseases; chronic alcohol consumption.
- Diseases and conditions interfere with subject ability to swallow the drug and to take oral medication;
- Concomitant therapy with olanzapine or other antipsychotic drugs; history of mental illness;
- Concomitant therapy with quinolone antibiotics;
- Contraindications for olanzapine or aprepitant administration;
- Intraperitoneal or intrapleural administration of HEC drugs;
- Inadequate hepatic and/or renal function.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
N.N. Blokhin Cancer Research Center
Moscow, 115478
Alexey A Rumyantsev, MD, +79100022255, alexeymma@gmail.com
Alexey A Rumyantsev, MD
About this study
Official title: Phase II Randomized Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis
Olanzapine-containing regimens for CINV prophylaxis may provide even better protection than aprepitant-containing regimens.
Read the detailed description
Olanzapine-containing regimens for CINV provide high complete response (CR) rate in patients receiving high emetogenic chemotherapy. Olanzapine may be more effective than aprepitant in this setting but cheaper. However, there is no strong evidence supporting the advantages of olanzapine over aprepitant - and this is the reason why aprepitant is still the standard of care. Due to high cost aprepitant can be not affordable in low- and middle income countries; this compromises quality of life of cancer patients. On the other hand, recommended olanzapine-based regimen includes palonosetron, whose price is quite high as well and undesired sedation is a common side effect for olanzapine doses that currently recommended, these adverse events precludes wide use of olanzapine in oncology. Development of effective, tolerable and affordable regimen for CINV prophylaxis based on low-dose olanzapine and short-acting 5-HT3 inhibitors can improve quality of care for many cancer patients.
- Conditions
- Emesis, Vomiting, Nausea Post Chemotherapy, Nausea, Chemotherapy-induced Nausea and Vomiting
- Being tested
- Olanzapine, Aprepitant Pill, Ondansetron, Dexamethasone
- Keywords
- olanzapine, aprepitant, CINV, nausea, vomiting, nausea and vomiting, antiemetics
- Medical subject headings
- Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Also called Zyprexa
Olanzapine 5 mg/day will be administered orally on days 0-4 of chemotherapy cycle (before bedtime)
Aprepitant PillDrug
Also called Emend
Aprepitant 125 mg orally will be administered on day 1 of chemotherapy cycle; 80 mg - on days 2 and 3.
OndansetronDrug
Ondansetron 16 mg IV on day 1 of chemotherapy cycle (as standard component of antiemetic therapy)
DexamethasoneDrug
Dexamethasone 8 mg IV on day 1 of chemotherapy cycle; 8 mg IV or orally on days 2-3 (as standard component of antiemetic therapy)
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine | Experimental | Olanzapine 5 mg/day p.o. d 0-4 + ondansetron 16 mg IV d 1 + dexamethasone 12 mg IV d 1, 8 mg b.i.d.; IM or P.O. d 2-4; Receives: Drug: Olanzapine; Drug: Ondansetron; Drug: Dexamethasone |
| Aprepitant | Active comparator | Aprepitant 125 mg p.o d 1 + 80 mg p.o d 2,3 + ondansetron 16 mg IV d 1 + dexamethasone 12 mg IV d 1, 8 mg b.i.d. IM or P.O. d 2-4; Receives: Drug: Aprepitant Pill; Drug: Ondansetron; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nausea control
Complete control of nausea (ie, no nausea) in overall treatment period (0-120 hours after chemotherapy).
Measured: 0-120 hours after chemotherapy
Secondary outcomes (4)
Complete Response Rate in Overall Treatment Period
Complete response rate (ie, no vomiting, no use of rescue medication) in 0-120 hours after chemotherapy
Measured: 0-120 hours after chemotherapy
Rate of undesired sedation
Rate of undesired sedation 0-120 hours after chemotherapy
Measured: 0-120 hours after chemotherapy
Complete Response Rate in Acute Treatment Period
Complete response rate (ie, no vomiting, no use of rescue medication) in 0-24 hours after chemotherapy
Measured: 0-24 hours after chemotherapy
Complete Response Rate in Delayed Treatment Period
Complete response rate (ie, no vomiting, no use of rescue medication) in 24-120 hours after chemotherapy
Measured: 24-120 hours after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start25 May 2018
- Primary completion25 May 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmesisStudies 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
- Model description
- Phase II randomized trial
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- RUSSCO/RakFond
- Responsible party
- Principal investigator, Alexey Rumyantsev, Blokhin's Russian Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478605
- Sponsor's protocol ID
- OlaCINV
- Other IDs
- 2018-01-YS-ECI
- Acronym
- OlaCINV
- Status last verified
- Jul 2018
- First submitted
- 14 Mar 2018
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis
- ClinicalTrials.gov ID
- NCT03478605
- Acronym / sponsor ID
- OlaCINV / OlaCINV
- Conditions
- Emesis, Vomiting, Nausea Post Chemotherapy, Nausea, Chemotherapy-induced Nausea and Vomiting
- Keywords
- olanzapine, aprepitant, CINV, nausea, vomiting, nausea and vomiting, antiemetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Blokhin's Russian Cancer Research CenterUniversity, hospital or other
- Collaborators
- RUSSCO/RakFond
- Study start
- 25 May 2018 (actual)
- Primary completion
- 25 May 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 27 Mar 2018 (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.
Olanzapine-containing regimens for CINV prophylaxis may provide even better protection than aprepitant-containing regimens.
Detailed description
Olanzapine-containing regimens for CINV provide high complete response (CR) rate in patients receiving high emetogenic chemotherapy. Olanzapine may be more effective than aprepitant in this setting but cheaper. However, there is no strong evidence supporting the advantages of olanzapine over aprepitant - and this is the reason why aprepitant is still the standard of care. Due to high cost aprepitant can be not affordable in low- and middle income countries; this compromises quality of life of cancer patients. On the other hand, recommended olanzapine-based regimen includes palonosetron, whose price is quite high as well and undesired sedation is a common side effect for olanzapine doses that currently recommended, these adverse events precludes wide use of olanzapine in oncology. Development of effective, tolerable and affordable regimen for CINV prophylaxis based on low-dose olanzapine and short-acting 5-HT3 inhibitors can improve quality of care for many cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase II randomized trial
| Arm | Type | Receives |
|---|---|---|
| Olanzapine | Experimental | Drug: Olanzapine, Drug: Ondansetron, Drug: DexamethasoneOlanzapine 5 mg/day p.o. d 0-4 + ondansetron 16 mg IV d 1 + dexamethasone 12 mg IV d 1, 8 mg b.i.d.; IM or P.O. d 2-4; |
| Aprepitant | Active comparator | Drug: Aprepitant Pill, Drug: Ondansetron, Drug: DexamethasoneAprepitant 125 mg p.o d 1 + 80 mg p.o d 2,3 + ondansetron 16 mg IV d 1 + dexamethasone 12 mg IV d 1, 8 mg b.i.d. IM or P.O. d 2-4; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- High-emetogenic chemotherapy (HEC) regimen (e.g., cisplatin ≥70 mg/m2 or doxorubicin ≥60 mg/m2 or carboplatin AUC≥4). Patients that are prescribed less doses of mentioned agents are still allowed if another high-emetogenic drug will be administered (eg, doxorubicin plus cisplatin);
- Administration of HEC component only in first day of the cycle;
- No previous chemotherapy or radiotherapy;
- No concomitant quinolone antibiotics administration;
- ECOG PS ≤2;
Key exclusion criteria (13 listed)
- Previous chemotherapy or radiotherapy;
- Moderate- or low- emetogenic chemotherapy;
- Multiday administration of HEC agents;
- ECOG PS >2;
- History of brain metastases, signs of symptoms of bowel obstruction;
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: ZyprexaOlanzapine 5 mg/day will be administered orally on days 0-4 of chemotherapy cycle (before bedtime) | Drug | Olanzapine |
| Aprepitant PillAlso: EmendAprepitant 125 mg orally will be administered on day 1 of chemotherapy cycle; 80 mg - on days 2 and 3. | Drug | Aprepitant |
| OndansetronOndansetron 16 mg IV on day 1 of chemotherapy cycle (as standard component of antiemetic therapy) | Drug | Aprepitant, Olanzapine |
| DexamethasoneDexamethasone 8 mg IV on day 1 of chemotherapy cycle; 8 mg IV or orally on days 2-3 (as standard component of antiemetic therapy) | Drug | Aprepitant, Olanzapine |
Primary outcome
Nausea control
Time frame: 0-120 hours after chemotherapy
Complete control of nausea (ie, no nausea) in overall treatment period (0-120 hours after chemotherapy).
4 secondary outcomes
Complete Response Rate in Overall Treatment Period
Time frame: 0-120 hours after chemotherapy
Rate of undesired sedation
Time frame: 0-120 hours after chemotherapy
Complete Response Rate in Acute Treatment Period
Time frame: 0-24 hours after chemotherapy
Complete Response Rate in Delayed Treatment Period
Time frame: 24-120 hours after chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Nausea, Vomiting
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.
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, Aprepitant Pill and Ondansetron in people with Emesis and Vomiting, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
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 13 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 5 Jul 2018. 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 Russia. 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. 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 Alexey A Rumyantsev, MD (+79100022255, alexeymma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nausea control (time frame: 0-120 hours after chemotherapy). 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 5 Jul 2018.