Trial Outcomes & Findings for Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)(0869-130)(COMPLETED) (NCT NCT00337727)
NCT ID: NCT00337727
Last Updated: 2017-06-02
Results Overview
The number of patients who reported No Vomiting in the overall phase in Cycle 1
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
848 participants
Primary outcome timeframe
Overall phase (0-120 hours post initiation of MEC) in Cycle 1.
Results posted on
2017-06-02
Participant Flow
This study was conducted at 58 investigative sites worldwide. The first patient entered the study on 16-Jan- 2007 and the last patient's last visit was on 28-Oct-2008.
Cancer patients naïve to both moderately and highly emetogenic chemotherapy (MEC and HEC, respectively) scheduled to receive an initial course of MEC for confirmed malignant disease. The study focused on patients receiving an initial cycle of MEC (Cycle 1).
Participant milestones
| Measure |
Aprepitant Regimen
Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
|
Standard Regimen
Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
|
|---|---|---|
|
Overall Study
STARTED
|
430
|
418
|
|
Overall Study
COMPLETED
|
412
|
406
|
|
Overall Study
NOT COMPLETED
|
18
|
12
|
Reasons for withdrawal
| Measure |
Aprepitant Regimen
Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
|
Standard Regimen
Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Protocol Violation
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
Baseline Characteristics
Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)(0869-130)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Aprepitant Regimen
n=430 Participants
Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
|
Standard Regimen
n=418 Participants
Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
|
Total
n=848 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
56.5 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
327 Participants
n=5 Participants
|
325 Participants
n=7 Participants
|
652 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
287 participants
n=5 Participants
|
296 participants
n=7 Participants
|
583 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
49 participants
n=5 Participants
|
35 participants
n=7 Participants
|
84 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
26 participants
n=5 Participants
|
20 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi-racial
|
50 participants
n=5 Participants
|
53 participants
n=7 Participants
|
103 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
18 participants
n=5 Participants
|
14 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
History of Motion Sickness
Yes
|
24 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
History of Motion Sickness
No
|
405 Participants
n=5 Participants
|
376 Participants
n=7 Participants
|
781 Participants
n=5 Participants
|
|
History of Motion Sickness
No Data - Assessment Not Completed
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
History of Vomiting with Pregnancy
Yes
|
61 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
History of Vomiting with Pregnancy
No
|
266 Participants
n=5 Participants
|
250 Participants
n=7 Participants
|
516 Participants
n=5 Participants
|
|
History of Vomiting with Pregnancy
Not Applicable- Male Patients
|
103 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Overall phase (0-120 hours post initiation of MEC) in Cycle 1.Population: FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderately Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed at least one post treatment efficacy assessment.
The number of patients who reported No Vomiting in the overall phase in Cycle 1
Outcome measures
| Measure |
Aprepitant Regimen
n=425 Participants
Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
|
Standard Regimen
n=406 Participants
Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
|
|---|---|---|
|
Number of Patients Who Reported No Vomiting
|
324 Participants
|
252 Participants
|
SECONDARY outcome
Timeframe: Overall phase (0-120 hours post initiation of MEC) in Cycle 1Population: FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received MEC, (2) took a dose of study drug, and (3) completed at least one post treatment efficacy assessment.
The number of patients who reported Complete Response (no vomiting and no use of rescue medication) in the overall phase in Cycle 1.
Outcome measures
| Measure |
Aprepitant Regimen
n=425 Participants
Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
|
Standard Regimen
n=407 Participants
Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
|
|---|---|---|
|
Number of Patients Who Reported Complete Response
|
292 Participants
|
229 Participants
|
Adverse Events
Aprepitant Regimen
Serious events: 12 serious events
Other events: 265 other events
Deaths: 0 deaths
Standard Regimen
Serious events: 20 serious events
Other events: 270 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aprepitant Regimen
n=430 participants at risk
Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
|
Standard Regimen
n=418 participants at risk
Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.93%
4/430
|
0.72%
3/418
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.23%
1/430
|
0.24%
1/418
|
|
Cardiac disorders
Myocardial Infarction
|
0.23%
1/430
|
0.00%
0/418
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/430
|
0.24%
1/418
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/430
|
0.24%
1/418
|
|
Gastrointestinal disorders
Ileitis
|
0.00%
0/430
|
0.24%
1/418
|
|
General disorders
General physical health deterioration
|
0.00%
0/430
|
0.24%
1/418
|
|
General disorders
Mucosal Inflammation
|
0.23%
1/430
|
0.00%
0/418
|
|
General disorders
Pyrexia
|
0.00%
0/430
|
0.24%
1/418
|
|
Infections and infestations
Abdominal Infection
|
0.00%
0/430
|
0.24%
1/418
|
|
Infections and infestations
Abscess Limb
|
0.23%
1/430
|
0.00%
0/418
|
|
Infections and infestations
Cellulitis
|
0.47%
2/430
|
0.24%
1/418
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/430
|
0.24%
1/418
|
|
Infections and infestations
Lobar pneumonia
|
0.23%
1/430
|
0.00%
0/418
|
|
Infections and infestations
Lung Infection
|
0.23%
1/430
|
0.00%
0/418
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/430
|
0.24%
1/418
|
|
Injury, poisoning and procedural complications
Compression Fracture
|
0.00%
0/430
|
0.24%
1/418
|
|
Metabolism and nutrition disorders
Dehydration
|
0.23%
1/430
|
0.00%
0/418
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.23%
1/430
|
0.00%
0/418
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/430
|
0.24%
1/418
|
|
Nervous system disorders
Syncope
|
0.00%
0/430
|
0.24%
1/418
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/430
|
0.24%
1/418
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/430
|
0.24%
1/418
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/430
|
0.24%
1/418
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/430
|
0.24%
1/418
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/430
|
0.24%
1/418
|
|
Vascular disorders
Arterial Occlusive Disease
|
0.00%
0/430
|
0.24%
1/418
|
|
Vascular disorders
Peripheral Ischemia
|
0.23%
1/430
|
0.00%
0/418
|
|
Vascular disorders
Superior Vena Cava Occlusion
|
0.23%
1/430
|
0.00%
0/418
|
Other adverse events
| Measure |
Aprepitant Regimen
n=430 participants at risk
Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
|
Standard Regimen
n=418 participants at risk
Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
2.3%
10/430
|
2.2%
9/418
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.0%
17/430
|
3.8%
16/418
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.1%
9/430
|
1.9%
8/418
|
|
Gastrointestinal disorders
Constipation
|
8.6%
37/430
|
12.7%
53/418
|
|
Gastrointestinal disorders
Diarrhoea
|
9.3%
40/430
|
11.0%
46/418
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
14/430
|
3.1%
13/418
|
|
Gastrointestinal disorders
Nausea
|
4.2%
18/430
|
2.6%
11/418
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
9/430
|
1.4%
6/418
|
|
General disorders
Asthenia
|
6.0%
26/430
|
5.5%
23/418
|
|
General disorders
Fatigue
|
10.9%
47/430
|
9.8%
41/418
|
|
General disorders
Mucosal Inflammation
|
1.9%
8/430
|
2.2%
9/418
|
|
Metabolism and nutrition disorders
Anorexia
|
8.1%
35/430
|
8.9%
37/418
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.2%
5/430
|
2.6%
11/418
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
5/430
|
2.2%
9/418
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
9/430
|
1.2%
5/418
|
|
Nervous system disorders
Dizziness
|
2.1%
9/430
|
2.6%
11/418
|
|
Nervous system disorders
Dysgeusia
|
0.70%
3/430
|
2.4%
10/418
|
|
Nervous system disorders
Headache
|
9.8%
42/430
|
11.7%
49/418
|
|
Nervous system disorders
Neuropathy Peripheral
|
2.1%
9/430
|
1.9%
8/418
|
|
Nervous system disorders
Paraesthesia
|
1.4%
6/430
|
2.2%
9/418
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.5%
28/430
|
7.7%
32/418
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER