Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis (OlaCINV)
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ClinicalTrials.gov Identifier: NCT03478605 |
Recruitment Status : Unknown
Verified July 2018 by Alexey Rumyantsev, Blokhin's Russian Cancer Research Center.
Recruitment status was: Recruiting
First Posted : March 27, 2018
Last Update Posted : July 5, 2018
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Condition or disease | Intervention/treatment | Phase |
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Emesis Vomiting Nausea Post Chemotherapy Nausea Chemotherapy-induced Nausea and Vomiting | Drug: Olanzapine Drug: Aprepitant Pill Drug: Ondansetron Drug: Dexamethasone | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 130 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Phase II randomized trial |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Randomized Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis |
Actual Study Start Date : | May 25, 2018 |
Estimated Primary Completion Date : | May 25, 2019 |
Estimated Study Completion Date : | June 1, 2019 |

Arm | Intervention/treatment |
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Experimental: Olanzapine
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;
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Drug: Olanzapine
Olanzapine 5 mg/day will be administered orally on days 0-4 of chemotherapy cycle (before bedtime)
Other Name: Zyprexa Drug: Ondansetron Ondansetron 16 mg IV on day 1 of chemotherapy cycle (as standard component of antiemetic therapy) Drug: Dexamethasone 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) |
Active Comparator: Aprepitant
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;
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Drug: Aprepitant Pill
Aprepitant 125 mg orally will be administered on day 1 of chemotherapy cycle; 80 mg - on days 2 and 3.
Other Name: Emend Drug: Ondansetron Ondansetron 16 mg IV on day 1 of chemotherapy cycle (as standard component of antiemetic therapy) Drug: Dexamethasone 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) |
- 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).
- Complete Response Rate in Overall Treatment Period [ Time Frame: 0-120 hours after chemotherapy ]Complete response rate (ie, no vomiting, no use of rescue medication) in 0-120 hours after chemotherapy
- Rate of undesired sedation [ Time Frame: 0-120 hours after chemotherapy ]Rate of undesired sedation 0-120 hours after chemotherapy
- Complete Response Rate in Acute Treatment Period [ Time Frame: 0-24 hours after chemotherapy ]Complete response rate (ie, no vomiting, no use of rescue medication) in 0-24 hours after chemotherapy
- Complete Response Rate in Delayed Treatment Period [ Time Frame: 24-120 hours after chemotherapy ]Complete response rate (ie, no vomiting, no use of rescue medication) in 24-120 hours after chemotherapy

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
- 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;
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478605
Contact: Alexey A Rumyantsev, MD | +79100022255 | alexeymma@gmail.com |
Russian Federation | |
N.N. Blokhin Cancer Research Center | Recruiting |
Moscow, Russian Federation, 115478 | |
Contact: Alexey A Rumyantsev, MD +79100022255 alexeymma@gmail.com | |
Principal Investigator: Alexey A Rumyantsev, MD | |
Principal Investigator: Ilya A Pokataev, MD |
Responsible Party: | Alexey Rumyantsev, MD, Blokhin's Russian Cancer Research Center |
ClinicalTrials.gov Identifier: | NCT03478605 |
Other Study ID Numbers: |
OlaCINV 2018-01-YS-ECI ( Other Grant/Funding Number: RUSSCO/RakFond ) |
First Posted: | March 27, 2018 Key Record Dates |
Last Update Posted: | July 5, 2018 |
Last Verified: | July 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
olanzapine aprepitant CINV nausea |
vomiting nausea and vomiting antiemetics |
Nausea Vomiting Signs and Symptoms, Digestive Dexamethasone Ondansetron Olanzapine Aprepitant Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Antipruritics Dermatologic Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Anti-Anxiety Agents Serotonin Uptake Inhibitors |