Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis

NCT03478605 | Unknown Phase 2 DMC

• 2 other identifiers: OlaCINV2018-01-YS-ECI
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Olanzapine-containing regimens for CINV prophylaxis may provide even better protection than aprepitant-containing regimens.

Conditions

Emesis; Vomiting; Nausea Post Chemotherapy; Nausea; Chemotherapy-induced Nausea and Vomiting

Keywords

olanzapine; aprepitant; CINV; nausea; vomiting; nausea and vomiting; antiemetics

Outcome Measures

Primary Outcomes (1)

• Nausea control

  Complete control of nausea (ie, no nausea) in overall treatment period (0-120 hours after chemotherapy).

  0-120 hours after chemotherapy

Secondary Outcomes (4)

• Complete Response Rate in Overall Treatment Period

  0-120 hours after chemotherapy

• Rate of undesired sedation

  0-120 hours after chemotherapy

• Complete Response Rate in Acute Treatment Period

  0-24 hours after chemotherapy

• Complete Response Rate in Delayed Treatment Period

  24-120 hours after chemotherapy

Study Arms (2)

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;

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;

Drug: Aprepitant Pill; Drug: Ondansetron; Drug: Dexamethasone

Interventions

Olanzapine DRUG

Olanzapine 5 mg/day will be administered orally on days 0-4 of chemotherapy cycle (before bedtime)

Also known as: Zyprexa

Olanzapine

Aprepitant Pill DRUG

Aprepitant 125 mg orally will be administered on day 1 of chemotherapy cycle; 80 mg - on days 2 and 3.

Also known as: Emend

Aprepitant

Ondansetron DRUG

Ondansetron 16 mg IV on day 1 of chemotherapy cycle (as standard component of antiemetic therapy)

Aprepitant; Olanzapine

Dexamethasone DRUG

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)

Aprepitant; Olanzapine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Blokhin's Russian Cancer Research Center: lead
• RUSSCO/RakFond: collaborator

Study Sites (1)

N.N. Blokhin Cancer Research Center

Moscow, 115478, Russia

RECRUITING

MeSH Terms

Conditions

Vomiting; Nausea

Interventions

Olanzapine; Aprepitant; Ondansetron; Dexamethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Alexey A Rumyantsev, MD

CONTACT

+79100022255; alexeymma@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Phase II randomized trial

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 27, 2018
• Study Start: May 25, 2018
• Primary Completion: May 25, 2019
• Study Completion: June 1, 2019
• Last Updated: July 5, 2018

Record last verified: 2018-07

Locations

RU (1)