Trial Outcomes & Findings for Study of FOND Versus FOND+O for the Prevention of CINV in Hematology Patients Receiving Highly Emetogenic Chemotherapy Regimens (NCT NCT02635984)

NCT ID: NCT02635984

Last Updated: 2018-08-20

Results Overview

Overall percentage of patients who had a complete response (CR) defined as no emesis and minimal nausea (\< 25 mm on a 100 mm visual analog scale \[VAS\]) during the overall assessment period (starting day 1 of chemotherapy and continuing for 5 days after discontinuation of chemotherapy) for the first cycle of chemotherapy.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 108 participants
• Primary outcome timeframe: Until study completion; estimated 1.5 years
• Results posted on: 2018-08-20

Participant Flow

Participant milestones

Measure	Triplet Therapy Plus Placebo All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy. Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy	Triplet Therapy Plus Olanzapine All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy. Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy
Overall Study STARTED	53	55
Overall Study COMPLETED	50	51
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	Triplet Therapy Plus Placebo All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy. Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy	Triplet Therapy Plus Olanzapine All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy. Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy
Overall Study Lost to Follow-up	2	4
Overall Study Study Arm Closed	1	0

Baseline Characteristics

Study of FOND Versus FOND+O for the Prevention of CINV in Hematology Patients Receiving Highly Emetogenic Chemotherapy Regimens

Baseline characteristics by cohort

Measure	Triplet Therapy Plus Placebo n=50 Participants All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy. Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy	Triplet Therapy Plus Olanzapine n=51 Participants All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy. Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy	Total n=101 Participants Total of all reporting groups
Age, Continuous	56 years n=5 Participants	54 years n=7 Participants	55 years n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	29 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	22 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	27 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Treatment Regimen Chemotherapy Alone	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Treatment Regimen HCT Conditioning	34 Participants n=5 Participants	34 Participants n=7 Participants	68 Participants n=5 Participants

PRIMARY outcome

Timeframe: Until study completion; estimated 1.5 years

Overall percentage of patients who had a complete response (CR) defined as no emesis and minimal nausea (< 25 mm on a 100 mm visual analog scale [VAS]) during the overall assessment period (starting day 1 of chemotherapy and continuing for 5 days after discontinuation of chemotherapy) for the first cycle of chemotherapy.

Outcome measures

Measure	Triplet Therapy Plus Placebo n=50 Participants All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy. Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy	Triplet Therapy Plus Olanzapine n=51 Participants All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy. Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy
Overall Percentage of Patients Who Had a Complete Response	13 Participants	28 Participants

SECONDARY outcome

Timeframe: Until study completion; estimated 1.5 years

Reported for overall phases [chemotherapy days plus 5 days after] where all VAS < 25 mm

Outcome measures

Measure	Triplet Therapy Plus Placebo n=50 Participants All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy. Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy	Triplet Therapy Plus Olanzapine n=51 Participants All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy. Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy
Percent of Patients With no Significant Nausea in Overall Assessment Period	14 Participants	30 Participants

SECONDARY outcome

Timeframe: Until study completion; estimated 1.5 years

(CP = no emesis, no breakthrough antiemetic use, no significant nausea). To be reported as overall phases [chemotherapy days plus 5 days after]

Outcome measures

Measure	Triplet Therapy Plus Placebo n=50 Participants All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy. Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy	Triplet Therapy Plus Olanzapine n=51 Participants All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy. Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy
Percent of Patients Achieving Complete Protection in Overall Assessment Phase	6 Participants	13 Participants

SECONDARY outcome

Timeframe: Until study completion; estimated 1.5 years

Reported as acute [chemotherapy days]. All assessment with all VAS < 25 mm on days of chemotherapy

Outcome measures

Measure	Triplet Therapy Plus Placebo n=50 Participants All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy. Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy	Triplet Therapy Plus Olanzapine n=51 Participants All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy. Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy
Percent of Participants With no Significant Nausea in Acute Phase	33 Participants	39 Participants

SECONDARY outcome

Timeframe: Until study completion; estimated 1.5 years

Reported for delayed [5 days after chemotherapy administration] All assessment with all VAS < 25 mm

Outcome measures

Measure	Triplet Therapy Plus Placebo n=50 Participants All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy. Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy	Triplet Therapy Plus Olanzapine n=51 Participants All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy. Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy
Percent of Participants With no Significant Nausea in Delayed Phase	16 Participants	34 Participants

SECONDARY outcome

Timeframe: Until study completion; estimated 1.5 years

No nausea (all VAS <5 mm) in overall assessment period (days of chemotherapy plus five days after)

Outcome measures

Measure	Triplet Therapy Plus Placebo n=50 Participants All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy. Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy	Triplet Therapy Plus Olanzapine n=51 Participants All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy. Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy
Percent of Patients With no Nausea in Overall Assessment Period	6 Participants	18 Participants

SECONDARY outcome

Timeframe: Until study completion; estimated 1.5 years

Complete response (no emesis and no more than minimal nausea, defined as < 25 mm on a 100 mm visual analog scale [VAS]) in acute phase (days of chemotherapy)

Outcome measures

Measure	Triplet Therapy Plus Placebo n=50 Participants All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy. Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy	Triplet Therapy Plus Olanzapine n=51 Participants All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy. Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy
Percent of Patients With Complete Response in Acute Phase	31 Participants	39 Participants

SECONDARY outcome

Timeframe: Until study completion; estimated 1.5 years

Complete response (no emesis and no more than minimal nausea, defined as < 25 mm on a 100 mm visual analog scale [VAS]) in delayed phase (5 days after chemotherapy)

Outcome measures

Measure	Triplet Therapy Plus Placebo n=50 Participants All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy. Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy	Triplet Therapy Plus Olanzapine n=51 Participants All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy. Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy
Percent of Patients With Complete Response in Delayed Phase	15 Participants	31 Participants

Adverse Events

Triplet Therapy Plus Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Triplet Therapy Plus Olanzapine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Triplet Therapy Plus Placebo n=50 participants at risk All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy. Placebo: Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy	Triplet Therapy Plus Olanzapine n=51 participants at risk All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy. Olanzapine: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy
General disorders Withdrawal From Study	6.0% 3/50 • Number of events 3 • All-cause mortality, serious, and other (non-serious) adverse events were not monitored/assessed during this study. Adverse events were reported only via quantification of number of subjects who withdrew from study for potential adverse events (by patient report or investigator discretion). The time frame in which withdrawal from study was monitored for each patient was the duration of active study period (chemotherapy plus five days after). All-cause mortality, serious, and other (non-serious) adverse events were not monitored/assessed. Adverse events were monitored only by quantifying number of subjects who withdrew from study for potential adverse events (by patient report or investigator discretion).	0.00% 0/51 • All-cause mortality, serious, and other (non-serious) adverse events were not monitored/assessed during this study. Adverse events were reported only via quantification of number of subjects who withdrew from study for potential adverse events (by patient report or investigator discretion). The time frame in which withdrawal from study was monitored for each patient was the duration of active study period (chemotherapy plus five days after). All-cause mortality, serious, and other (non-serious) adverse events were not monitored/assessed. Adverse events were monitored only by quantifying number of subjects who withdrew from study for potential adverse events (by patient report or investigator discretion).

Additional Information

Dr. Amber Clemmons, Clinical Pharmacist - BMT/Hematology & Clinical Associate Professor

AU Medical Center / University of Georgia College of Pharmacy

Phone: 706-721-6493

Email: aclemmons@augusta.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place