Trial Outcomes & Findings for Aprepitant as Antiemetic Prophylaxis in Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy (NCT NCT01334086)
NCT ID: NCT01334086
Last Updated: 2021-11-22
Results Overview
Cumulative incidence will be determined by the patient self-assessment form, supplemented by the nursing inpatient records.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Day 1 through end of Day 5
Results posted on
2021-11-22
Participant Flow
Participant milestones
| Measure |
Aprepitant
Aprepitant: Oral aprepitant will be given to the participant on Days 1-5 of standard induction treatment. A dose of 125 mg will be given on Day 1 and 80 mg will be given on Days 2-5.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aprepitant as Antiemetic Prophylaxis in Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy
Baseline characteristics by cohort
| Measure |
Aprepitant
n=41 Participants
Aprepitant: Oral aprepitant will be given to the participant on Days 1-5 of standard induction treatment. A dose of 125 mg will be given on Day 1 and 80 mg will be given on Days 2-5.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through end of Day 5Cumulative incidence will be determined by the patient self-assessment form, supplemented by the nursing inpatient records.
Outcome measures
| Measure |
Aprepitant
n=38 Participants
Aprepitant: Oral aprepitant will be given to the participant on Days 1-5 of standard induction treatment. A dose of 125 mg will be given on Day 1 and 80 mg will be given on Days 2-5.
|
|---|---|
|
Percentage of Participants With Incidence of Vomiting/Retching From Day 1 Through End of Day 5
|
26.3 percentage of particpants
|
SECONDARY outcome
Timeframe: Days 1 to 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 to 8This will be determined by both self-assessment form which will be filled out by the patient on a daily basis, and review of the nursing inpatient records.
Outcome measures
| Measure |
Aprepitant
n=38 Participants
Aprepitant: Oral aprepitant will be given to the participant on Days 1-5 of standard induction treatment. A dose of 125 mg will be given on Day 1 and 80 mg will be given on Days 2-5.
|
|---|---|
|
Daily Number of Vomiting or Retching Incidents From Days 1-8
Day 1
|
7 incidents
|
|
Daily Number of Vomiting or Retching Incidents From Days 1-8
Day 2
|
11 incidents
|
|
Daily Number of Vomiting or Retching Incidents From Days 1-8
Day 3
|
16 incidents
|
|
Daily Number of Vomiting or Retching Incidents From Days 1-8
Day 4
|
13 incidents
|
|
Daily Number of Vomiting or Retching Incidents From Days 1-8
Day 5
|
13 incidents
|
|
Daily Number of Vomiting or Retching Incidents From Days 1-8
Day 6
|
24 incidents
|
|
Daily Number of Vomiting or Retching Incidents From Days 1-8
Day 7
|
13 incidents
|
|
Daily Number of Vomiting or Retching Incidents From Days 1-8
Day 8
|
11 incidents
|
SECONDARY outcome
Timeframe: Days 1 to 8This will be determined by both self-assessment form which will be filled out by the patient on a daily basis, and review of the nursing inpatient records.
Outcome measures
| Measure |
Aprepitant
n=38 Participants
Aprepitant: Oral aprepitant will be given to the participant on Days 1-5 of standard induction treatment. A dose of 125 mg will be given on Day 1 and 80 mg will be given on Days 2-5.
|
|---|---|
|
Percentage of Participants Experiencing Vomiting or Retching From Days 1-8.
|
34.2 percentage of particpants
|
SECONDARY outcome
Timeframe: Days 1 to 8Outcome measures
| Measure |
Aprepitant
n=38 Participants
Aprepitant: Oral aprepitant will be given to the participant on Days 1-5 of standard induction treatment. A dose of 125 mg will be given on Day 1 and 80 mg will be given on Days 2-5.
|
|---|---|
|
Percentage of Patients Experiencing Nausea From Days 1-8.
|
68.4 percentage of particpants
|
SECONDARY outcome
Timeframe: Days 1 to 8Outcome measures
| Measure |
Aprepitant
n=41 Participants
Aprepitant: Oral aprepitant will be given to the participant on Days 1-5 of standard induction treatment. A dose of 125 mg will be given on Day 1 and 80 mg will be given on Days 2-5.
|
|---|---|
|
Percentage of Patients' Use of Supplemental Anti-emetics as Determined by the Total Number of Doses Per Day and in Total, From Days 1-8.
Day 1
|
18 % of pts receiving breakthrough
|
|
Percentage of Patients' Use of Supplemental Anti-emetics as Determined by the Total Number of Doses Per Day and in Total, From Days 1-8.
Day 2
|
29 % of pts receiving breakthrough
|
|
Percentage of Patients' Use of Supplemental Anti-emetics as Determined by the Total Number of Doses Per Day and in Total, From Days 1-8.
Day 3
|
39 % of pts receiving breakthrough
|
|
Percentage of Patients' Use of Supplemental Anti-emetics as Determined by the Total Number of Doses Per Day and in Total, From Days 1-8.
Day 4
|
58 % of pts receiving breakthrough
|
|
Percentage of Patients' Use of Supplemental Anti-emetics as Determined by the Total Number of Doses Per Day and in Total, From Days 1-8.
Day 5
|
65 % of pts receiving breakthrough
|
|
Percentage of Patients' Use of Supplemental Anti-emetics as Determined by the Total Number of Doses Per Day and in Total, From Days 1-8.
Day 6
|
75 % of pts receiving breakthrough
|
|
Percentage of Patients' Use of Supplemental Anti-emetics as Determined by the Total Number of Doses Per Day and in Total, From Days 1-8.
Day 7
|
68 % of pts receiving breakthrough
|
|
Percentage of Patients' Use of Supplemental Anti-emetics as Determined by the Total Number of Doses Per Day and in Total, From Days 1-8.
Day 8
|
53 % of pts receiving breakthrough
|
SECONDARY outcome
Timeframe: Days 1 to 8Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 to 8Outcome measures
Outcome data not reported
Adverse Events
Aprepitant
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aprepitant
n=41 participants at risk
Aprepitant: Oral aprepitant will be given to the participant on Days 1-5 of standard induction treatment. A dose of 125 mg will be given on Day 1 and 80 mg will be given on Days 2-5.
|
|---|---|
|
Gastrointestinal disorders
Vomitting
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.4%
1/41 • Number of events 1
|
Other adverse events
| Measure |
Aprepitant
n=41 participants at risk
Aprepitant: Oral aprepitant will be given to the participant on Days 1-5 of standard induction treatment. A dose of 125 mg will be given on Day 1 and 80 mg will be given on Days 2-5.
|
|---|---|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
4.9%
2/41 • Number of events 2
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
7.3%
3/41 • Number of events 3
|
|
Blood and lymphatic system disorders
ANEMIA
|
4.9%
2/41 • Number of events 2
|
|
Metabolism and nutrition disorders
ANOREXIA
|
31.7%
13/41 • Number of events 13
|
|
Psychiatric disorders
ANXIETY
|
12.2%
5/41 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
7.3%
3/41 • Number of events 3
|
|
Eye disorders
BLURRED VISION
|
9.8%
4/41 • Number of events 4
|
|
Injury, poisoning and procedural complications
BRUISING
|
7.3%
3/41 • Number of events 3
|
|
General disorders
CHILLS
|
22.0%
9/41 • Number of events 10
|
|
Gastrointestinal disorders
CONSTIPATION
|
4.9%
2/41 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
14.6%
6/41 • Number of events 6
|
|
Psychiatric disorders
DEPRESSION
|
4.9%
2/41 • Number of events 2
|
|
Gastrointestinal disorders
DIARRHEA
|
43.9%
18/41 • Number of events 19
|
|
Nervous system disorders
DIZZINESS
|
24.4%
10/41 • Number of events 10
|
|
Gastrointestinal disorders
DRY MOUTH
|
7.3%
3/41 • Number of events 3
|
|
Nervous system disorders
DYSGEUSIA
|
9.8%
4/41 • Number of events 4
|
|
Gastrointestinal disorders
DYSPEPSIA
|
12.2%
5/41 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
14.6%
6/41 • Number of events 6
|
|
Eye disorders
EYE PAIN
|
4.9%
2/41 • Number of events 2
|
|
General disorders
FATIGUE
|
24.4%
10/41 • Number of events 10
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
46.3%
19/41 • Number of events 19
|
|
General disorders
FEVER
|
9.8%
4/41 • Number of events 4
|
|
Vascular disorders
FLUSHING
|
7.3%
3/41 • Number of events 3
|
|
Nervous system disorders
HEADACHE
|
39.0%
16/41 • Number of events 16
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
7.3%
3/41 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
9.8%
4/41 • Number of events 4
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
14.6%
6/41 • Number of events 6
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
7.3%
3/41 • Number of events 3
|
|
Vascular disorders
HYPOTENSION
|
31.7%
13/41 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
4.9%
2/41 • Number of events 2
|
|
Psychiatric disorders
INSOMNIA
|
9.8%
4/41 • Number of events 4
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
46.3%
19/41 • Number of events 21
|
|
Gastrointestinal disorders
NAUSEA
|
61.0%
25/41 • Number of events 27
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
7.3%
3/41 • Number of events 3
|
|
General disorders
DYSOSMIA
|
4.9%
2/41 • Number of events 2
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
9.8%
4/41 • Number of events 5
|
|
Gastrointestinal disorders
ORAL HEMORRHAGE
|
4.9%
2/41 • Number of events 2
|
|
Gastrointestinal disorders
ORAL PAIN
|
9.8%
4/41 • Number of events 4
|
|
General disorders
PAIN
|
7.3%
3/41 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
12.2%
5/41 • Number of events 5
|
|
Nervous system disorders
PARESTHESIA
|
9.8%
4/41 • Number of events 4
|
|
Investigations
PLATELET COUNT DECREASED
|
4.9%
2/41 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
9.8%
4/41 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
24.4%
10/41 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
22.0%
9/41 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
22.0%
9/41 • Number of events 10
|
|
Infections and infestations
SEPSIS
|
4.9%
2/41 • Number of events 2
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
7.3%
3/41 • Number of events 3
|
|
Infections and infestations
SKIN INFECTION
|
12.2%
5/41 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
SKIN ULCERATION
|
4.9%
2/41 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
7.3%
3/41 • Number of events 3
|
|
Gastrointestinal disorders
STOMACH PAIN
|
4.9%
2/41 • Number of events 2
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
4.9%
2/41 • Number of events 2
|
|
Gastrointestinal disorders
VOMITING
|
9.8%
4/41 • Number of events 4
|
|
General disorders
EDEMA LIMBS
|
19.5%
8/41 • Number of events 10
|
|
Infections and infestations
LUNG INFECTION
|
12.2%
5/41 • Number of events 5
|
|
General disorders
LOCALIZED EDEMA
|
4.9%
2/41 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
9.8%
4/41 • Number of events 4
|
|
Infections and infestations
PAPULOPUSTULAR RASH
|
7.3%
3/41 • Number of events 3
|
Additional Information
Dr. Karen Yee, Hematology and Medical Oncology Site Group Lead
Princess Margaret Cancer Centre
Phone: 416-946-4501
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place