Trial Outcomes & Findings for Aprepitant in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant (NCT NCT00248547)

Results Overview

To compare the efficacy of aprepitant plus standard therapy to placebo plus standard therapy in control of nausea and vomiting during conditioning therapy for autologous or allogeneic hematopoietic stem cell transplantation (HSCT) as defined by the number of retch/emesis free days during the study period

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Up to three weeks

Results posted on

2017-05-09

Participant Flow

Inpatients receiving allogeneic bone marrow transplants who were to get either Busulfan/Cytoxan or Cytoxan/Total Body Radiation as conditioning regimen.

Participant milestones

Participant milestones
Measure	Aprepitant Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant	Placebo Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aprepitant in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aprepitant n=20 Participants Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant	Placebo n=20 Participants Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	46 years STANDARD_DEVIATION 12.9 • n=5 Participants	46 years STANDARD_DEVIATION 13 • n=7 Participants	46 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to three weeks

To compare the efficacy of aprepitant plus standard therapy to placebo plus standard therapy in control of nausea and vomiting during conditioning therapy for autologous or allogeneic hematopoietic stem cell transplantation (HSCT) as defined by the number of retch/emesis free days during the study period

Outcome measures

Outcome measures
Measure	Aprepitant n=20 Participants Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant	Placebo (Sugar Pill) n=20 Participants Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
Number of Emesis Free Participants During the Study Period.	13 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to three weeks

To assess the safety of aprepitant in the bone marrow transplant population

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to three weeks

To assess the effects of aprepitant on nausea, appetite, and taste changes, (via visual analogue scale \[VAS\]), nutritional intake, and mucositis in the bone marrow transplant population.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to three weeks

To assess the potential for aprepitant and cyclophosphamide to interact pharmacokinetically in a significant manner to change blood levels of aprepitant, cyclophosphamide, hydroxycyclophosphamide or CEPM.

Outcome measures

Outcome data not reported

Adverse Events

Aprepitant

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Aprepitant n=20 participants at risk Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant	Placebo n=20 participants at risk Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
Gastrointestinal disorders Subileus	10.0% 2/20	0.00% 0/20

Other adverse events

Adverse event data not reported

Additional Information

Joseph Bubalo, PharmD

Oregon Health & Science University, Knight Cancer Institute

Phone: 503-494-1054

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place