Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Chinese Breast Cancer Patients

NCT03079219 | Completed Phase 3

• 1 other identifier: SYM010
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The Olanzapine Regimen will be superior to the Standard Regimen, as measured by the proportion of patients with Complete Response in the 120 hours following AC chemotherapy.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Number of episodes of nausea in the first 120 hours after first cycle of chemotherapy.

  Number of episodes of nausea in the first 120 hours after first cycle of chemotherapy.

  120 hours

• Number of episodes of vomiting in the first 120 hours after first cycle of chemotherapy.

  Number of episodes of vomiting in the first 120 hours after first cycle of chemotherapy.

  120 hours

Secondary Outcomes (2)

• Number of episodes of nausea in the first 120 hours during 4 cycles of chemotherapy.

  120 hours

• Number of episodes of vomiting in the first 120 hours during 4 cycles of chemotherapy.

  120 hours

Study Arms (2)

Experimental

EXPERIMENTAL

Aprepitant, Ondansetron, Dexamethasone and Olanzapine

Drug: Experimental drug: Aprepitant; Drug: Experimental drug: Ondansetron; Drug: Experimental drug: Dexamethasone; Drug: Experimental drug: Olanzapine

Standard

OTHER

Aprepitant, Ondansetron, Dexamethasone

Drug: Standard: Aprepitant; Drug: Standard: Ondansetron; Drug: Standard: Dexamethasone

Interventions

Experimental drug: Aprepitant DRUG

Day 1: 125mg QD; Day 2 to Day 3: 80mg QD

Experimental

Experimental drug: Ondansetron DRUG

Day 1: 8mg BD, First dose 8mg, Second dose 8mg, 8 hours after first dose

Experimental

Experimental drug: Dexamethasone DRUG

Day 1: 12mg QD

Experimental

Experimental drug: Olanzapine DRUG

Day 1 to Day 5: 10mg QD

Experimental

Standard: Aprepitant DRUG

Day 1: 125mg QD, Day 2 to Day3: 80mg QD

Standard

Standard: Ondansetron DRUG

Day 1: 8mg BD, First dose 8mg, second dose 8mg, 8 hours after first dose

Standard

Standard: Dexamethasone DRUG

Day 1: 12mg QD ; Day 2 to Day 3: 4mg BD

Standard

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese patient, female \>=18 and \< 75 years of age.
• Patient is diagnosed with early breast cancer.
• Patient is naïve to emetogenic chemotherapy moderately or highly emetogenecity.
• Patient is scheduled to receive her first course of adjuvant chemotherapy for breast cancer follows:
• IV adriamycin 60 mg/m2 + cyclophosphamide 600 mg/m2
• Patient has a predicted life expectancy of \>=4 months.
• Patient has ECOG Performance Status of 0-1
• Premenopausal female patients must not be pregnant (documented negative urine pregnancy test).
• Patient is able to read, understand and complete study questionnaires and diary, including questions requiring a visual analog scale (VAS) response.
• Patient understands the procedures and agrees to participate in the study by giving written informed consent

You may not qualify if:

• Patient with advanced breast cancer.
• Patient receiving cisplatin or any other chemotherapy of higher emetogenic potential, except for cyclophosphamide and doxorubicin in the regimens described above.
• Patients who are scheduled to receive concurrent radiation as part of their chemotherapy regimen for their malignancy
• Patients who experience any vomiting or grade 2-3 nausea per Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.03) in the 24 hours before Day 1 of chemotherapy
• Patient has a history of treatment with moderately to highly emetogenic chemotherapy.
• Patient has an active infection (e.g., pneumonia, systemic fungal infection) or any uncontrolled disease (e.g., diabetes mellitus, hypertension) which, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk.
• Patient with history of glaucoma, dementia, seizures, Parkinson's disease, Neuroleptic Malignant Syndrome (NMS), thromboembolic events.
• Patient currently uses any illicit drugs, including marijuana, or has current evidence of alcohol abuse as determined by the investigator.
• Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.
• Patients who are regular alcohol drinker or smoker
• Patient has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk.
• Patient has a history of hypersensitivity to aprepitant, ondansetron or dexamethasone.
• Patients who have phenylketonuria and abnormal uric acid.
• Any investigational drugs taken within 4 weeks prior to Day 1 of cycle 1, and/or is scheduled to receive any investigational drug during the study;
• Patient is taking systemic corticosteroid therapy at any dose; however, topical and inhaled corticosteroids are permitted.

Sponsors & Collaborators

• CCTU: lead

Study Sites (1)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Winnie Yeo, MD, FRCP

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Comprehensive Clinical Trial Unit

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: March 14, 2017
• Study Start: March 23, 2017
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

HK (1)