Olanzapine Versus Aprepitant Based Antiemetic Regimen for... | NCT03876938

Studies
Olanzapine Versus Aprepitant Based Antiemetic Regimen for High Emetic Chemotherapy

NCT03876938

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

Mar 15, 2019Actual

Enrollment

147Estimated

Phase

Phase 3

Conditions

Antiemetic for Highly Emetogenic Chemotherapy

Interventions

aprepitant
olanzapine 10 mg
olanzapine 5 mg

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2019Actual

Primary Completion Date

Aug 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Mar 14, 2019

First Submission Date that Met QC Criteria

Mar 14, 2019

First Posted Date

Mar 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2019

Last Update Posted Date

Mar 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

Aprepitant and olanzapine have been recommended for emesis prevention from highly emetogenic chemotherapy. We hypothesized that olanzapine may lead to less nausea compared to aprepitant based on previous study. However, data on efficacy and adverse effects of combination of olanzapine and ondansetron which is only serotonin antagonist in Thai national essential drug list, is scarce. Also, we aims to assess the efficacy of olanzapine dosage of 5 mg which is more commonly used in Thai patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

147Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
aprepitant	Active Comparator	aprepitant / dexamethasone/ ondansetron	Drug: aprepitant
olanzapine 10 mg	Experimental	olanzapine 10 mg/dexamethasone/ ondansetron	Drug: olanzapine 10 mg
olanzapine 5 mg	Experimental	olanzapine 5 mg/dexamethasone/ ondansetron	Drug: olanzapine 5 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
aprepitant	Drug	aprepitant 125 mg orally, dexamethasone 12 mg iv, ondansetron 8 mg iv before chemotherapy aprepitant 80 mg orally D2-4, dexamethasone 8 mg/day orally D2-4	aprepitant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
no nausea rate	proportion of patients report no nausea	Days 1-5 of chemotherapy

Secondary Outcomes

Measure	Description	Time Frame
complete remission	no episode of vomiting	Days 1-5 of chemotherapy
>= grade 3 vomiting	higher than grade 3 vomiting	Days 1-5 of chemotherapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pathologically proved of solid malignancy
receive first cycle of cisplatin >= 50 mg/m2 or cyclophosphamide/doxorubicin

Exclusion Criteria:

pregnancy
patients with episode of vomiting within 24 hours before starting chemotherapy
uncontrolled brain/ CNS metastasis
gut obstruction
receive combination of moderate or high emetogenic chemotherapy during Day 2-5
Known allergy to ondansetron, olanzapine, aprepitant or dexamethasone
currently receive olanzapine with other indication and plan to continue the drug

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Suthinee Ithimakin, MD	Contact	+6624194489		aesi105@yahoo.co.th

Overall Officials

Name	Affiliation	Role
Suthinee Ithimakin, MD	Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of medical oncology, department of medicine Siriraj Hospital	Recruiting	Bangkok		10700	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077608	Aprepitant
D000077152	Olanzapine

Ancestor Terms

ID	Term
D009025	Morpholines
D010078	Oxazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided