Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for... | NCT02484911

NCT02484911

Status Module

Sponsor/Collaborators Module

Name	Class
Harbin Medical University	OTHER

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Olanzapine regimen	Experimental	Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.	Drug: Olanzapine Drug: Aprepitant Drug: Palonosetron Drug: Dexamethasone
Control regimen	Other	Aprepitant in combination with palonosetron and dexamethasone	Drug: Aprepitant Drug: Palonosetron Drug: Dexamethasone

Name	Type	Description	Arm Group Labels	Other Names
Olanzapine	Drug	5mg,twice a day orally on day 1 to day 4	Olanzapine regimen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of Participants Receiving HEC With Complete Response in Overall Phase	Overall phase was defined as 0 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.	0 to 120 hours
Proportion of Participants Receiving MEC With Complete Response in Overall Phase	Overall phase was defined as 0 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.	0 to 120 hours

Secondary Outcomes

Measure	Description	Time Frame
Proportion of Participants Receiving HEC With Complete Response in the Acute Phase	Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.	0 to 24 hours
Proportion of Participants Receiving HEC With Complete Response in the Delayed Phase

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Daxin Zhang, MD	First Affiliated Hospital of Harbin Medical University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
First Affiliated Hospital of Harbin Medical University		Harbin	Heilongjiang	150000	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9629870	Background	Andrews PL, Naylor RJ, Joss RA. Neuropharmacology of emesis and its relevance to anti-emetic therapy. Consensus and controversies. Support Care Cancer. 1998 May;6(3):197-203. doi: 10.1007/s005200050154.
8181539	Background	Matsuki N, Torii Y, Saito H. Effects of iron and deferoxamine on cisplatin-induced emesis: further evidence for the role of free radicals. Eur J Pharmacol. 1993 Dec 1;248(4):329-31. doi: 10.1016/0926-6917(93)90008-e.

Label	URL
Related Info	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Olanzapine Regimen	Olanzapine in combination with aprepitant ,palonosetron and dexamethasone. Olanzapine: 5mg,twice a day orally on day 1 to day 4 Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3. Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1 Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Olanzapine Regimen	Olanzapine in combination with aprepitant ,palonosetron and dexamethasone. Olanzapine: 5mg,twice a day orally on day 1 to day 4 Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3. Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1 Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4
BG001	Control Regimen	Aprepitant in combination with palonosetron and dexamethasone Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3. Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1 Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00055.43± 9.55 BG00152.98± 10.81 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00033 BG00137 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

China

Title	Measurements
	BG00056 BG00156 BG002

History of drinking

Number

participants

Title

Denominators

Categories

YES

Title	Measurements
	BG00015 BG0019 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Proportion of Participants Receiving HEC With Complete Response in Overall Phase

Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.

Complete response was defined as no vomiting with no rescue therapy.

FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.

Posted

Count of Participants

Participants

0 to 120 hours

ID	Title	Description
OG000	Olanzapine Regimen	Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
OG001	Control Regimen	Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV

Units	Counts
Participants	OG00020 OG00117

Title

Denominators

Categories

Title	Measurements
	OG00020 OG00115

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Chi-squared		0.397														Superiority or Other

Primary

Proportion of Participants Receiving MEC With Complete Response in Overall Phase

Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.

Complete response was defined as no vomiting with no rescue therapy.

FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.

Posted

Count of Participants

Participants

0 to 120 hours

ID	Title	Description
OG000	Olanzapine Regimen	Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
OG001	Control Regimen	Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV

Units	Counts

Secondary

Proportion of Participants Receiving HEC With Complete Response in the Acute Phase

Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.

Posted

Count of Participants

Participants

0 to 24 hours

ID	Title	Description
OG000	Olanzapine Regimen	Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
OG001	Control Regimen	Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV

Units	Counts

Secondary

Proportion of Participants Receiving HEC With Complete Response in the Delayed Phase

Delayed phase was defined as 24 to 120 hours following initiation of chemotherapy.

Complete response was defined as no vomiting with no rescue therapy.

Posted

Count of Participants

Participants

24 to 120 hours

ID	Title	Description
OG000	Olanzapine Regimen	Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
OG001	Aprepitant Regimen	Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV

Units	Counts

Secondary

Proportion of Participants Receiving HEC With No Vomiting in the Overall Phase

Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.

No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).

Posted

Count of Participants

Participants

0 to 120 hours

ID	Title	Description
OG000	Olanzapine Regimen	Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
OG001	Control Regimen	Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV

Units

Secondary

Proportion of Participants Receiving HEC With No Vomiting in the Acute Phase

Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.

No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue ）

Posted

Count of Participants

Participants

0 to 24 hours

ID	Title	Description
OG000	Olanzapine Regimen	Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
OG001	Control Regimen	Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV

Units	Counts

Secondary

Proportion of Participants Receiving HEC With No Vomiting in the Delayed Phase

Overall Phase was defined as 24 to 120 hours following initiation of chemotherapy.

No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).

Posted

Count of Participants

Participants

24 to 120 hours

ID	Title	Description
OG000	Olanzapine Regimen	Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
OG001	Control Regimen	Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV

Units

Secondary

Proportion of Participants Receiving MEC With Complete Response in the Acute Phase

Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.

Posted

Count of Participants

Participants

0 to 24 hours

ID	Title	Description
OG000	Olanzapine Regimen	Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
OG001	Control Regimen	Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV

Units	Counts

Secondary

Proportion of Participants Receiving MEC With Complete Response in the Delayed Phase

Delayed phase was defined as 24 to 120 hours following initiation of chemotherapy.

Complete response was defined as no vomiting with no rescue therapy.

Posted

Count of Participants

Participants

24 to 120 hours

ID	Title	Description
OG000	Olanzapine Regimen	Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
OG001	Control Regimen	Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV

Units	Counts

Secondary

Proportion of Participants Receiving MEC With No Vomiting in the Overall Phase

Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.

No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).

Posted

Count of Participants

Participants

0-120 hours

ID	Title	Description
OG000	Olanzapine Regimen	Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
OG001	Control Regimen	Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV

Units

Secondary

Proportion of Participants Receiving MEC With No Vomiting in the Acute Phase

Overall Phase was defined as 0 to 24 hours following initiation of chemotherapy.

No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).

Posted

Count of Participants

Participants

0 to 24 hours

ID	Title	Description
OG000	Olanzapine Regimen	Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
OG001	Control Regimen	Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV

Units

Secondary

Proportion of Participants Receiving MEC With No Vomiting in the Delayed Phase

Overall Phase was defined as 24 to 120 hours following initiation of chemotherapy.

No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).

Posted

Count of Participants

Participants

24 to 120 hours

ID	Title	Description
OG000	Olanzapine Regimen	Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
OG001	Control Regimen	Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV

Units

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Olanzapine Regimen	Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV	0	56	0	56	21	56
EG001	Control Regimen	Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV	0	58	0	58	14	58

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Abdominal distension	Gastrointestinal disorders	Non-systematic Assessment	EG0004 affected56 at risk EG0015 affected58 at risk
Drowsiness	Nervous system disorders	Non-systematic Assessment	EG00011 affected56 at risk EG0010 affected58 at risk
Dizzy	Nervous system disorders	Non-systematic Assessment	EG0002 affected56 at risk EG0010 affected58 at risk
Headache	Nervous system disorders	Non-systematic Assessment	EG0001 affected56 at risk EG0013 affected58 at risk
Fatigue	General disorders	Non-systematic Assessment	EG0000 affected56 at risk EG0012 affected58 at risk
dry mouth	General disorders	Non-systematic Assessment	EG0001 affected56 at risk EG0011 affected58 at risk
Oral ulcer	General disorders	Non-systematic Assessment	EG0000 affected56 at risk EG0011 affected58 at risk
Abdominal distension	Gastrointestinal disorders	Non-systematic Assessment	EG0002 affected56 at risk EG0012 affected58 at risk

ID	Term
D014839	Vomiting

ID	Term
D000077152	Olanzapine
D000077608	Aprepitant
D000077924	Palonosetron
D003907	Dexamethasone

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D009025	Morpholines
D010078	Oxazines
D006573	Heterocyclic Compounds, 1-Ring
D011812	Quinuclidines
D006572	Heterocyclic Compounds, Bridged-Ring
D007546	Isoquinolines
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms