Trial Outcomes & Findings for Emend and Ondansetron Compared to Ondansetron Alone to Prevent CINV in Glioma Patients Receiving Temozolomide (NCT NCT01450826)
NCT ID: NCT01450826
Last Updated: 2018-06-26
Results Overview
Complete control (CC): study days 1-7 (acute and delayed CINV) the proportion of patients achieving complete control (CC); defined as no emetic episode, no need for rescue medication during days 1-7; number of emetic episodes daily; time to first emetic episode; as captured by the MAT (MASCC Antiemesis Tool)/Osoba survey (MASCC refers to Multinational Association for Supportive Care in Cancer™). Severity of nausea and other toxicities measured daily by the NCI Common Toxicity Criteria (version 4.0).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
136 participants
Primary outcome timeframe
7 days
Results posted on
2018-06-26
Participant Flow
Participant milestones
| Measure |
Aprepitant+Ondansetron
On day 1, patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide). Additionally, On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.
Aprepitant: On day 1, eligible patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide).
Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen.
|
Ondansetron
On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.
Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
66
|
|
Overall Study
COMPLETED
|
70
|
66
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Aprepitant+Ondansetron
n=70 Participants
On day 1, patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide). Additionally, On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.
Aprepitant: On day 1, eligible patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide).
Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen.
|
Ondansetron
n=66 Participants
On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.
Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.96 years
STANDARD_DEVIATION 14.25 • n=70 Participants
|
55.03 years
STANDARD_DEVIATION 12.17 • n=66 Participants
|
53.96 years
STANDARD_DEVIATION 13.27 • n=136 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=70 Participants
|
24 Participants
n=66 Participants
|
53 Participants
n=136 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=70 Participants
|
42 Participants
n=66 Participants
|
83 Participants
n=136 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 7 daysPopulation: Intent to treat
Complete control (CC): study days 1-7 (acute and delayed CINV) the proportion of patients achieving complete control (CC); defined as no emetic episode, no need for rescue medication during days 1-7; number of emetic episodes daily; time to first emetic episode; as captured by the MAT (MASCC Antiemesis Tool)/Osoba survey (MASCC refers to Multinational Association for Supportive Care in Cancer™). Severity of nausea and other toxicities measured daily by the NCI Common Toxicity Criteria (version 4.0).
Outcome measures
| Measure |
Aprepitant+Ondansetron
n=70 Participants
On day 1, patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide). Additionally, On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.
Aprepitant: On day 1, eligible patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide).
Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen.
|
Ondansetron
n=66 Participants
On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.
Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen.
|
|---|---|---|
|
Proportion of Patients Achieving Complete Control (CC)
|
0.59 proportion of patients
|
0.55 proportion of patients
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Intent to treat
CR is the proportion of patients with no emetic episode and no rescue medication. (1) Assessed from the beginning of study day 1, CR is defined for acute CINV as no emetic episode and no use of rescue anti-nausea medication during the first 24 hours following chemotherapy administration. An emetic episode is defined as one episode of vomiting or a sequence of episodes in very close succession not relieved by a period of relaxation of at least 1 min, any number of unproductive emetic episodes (retches) in any given 5 minute period, or an episode of retching lasting \<5 minutes combined with vomiting not relieved by a period of relaxation of at least 1 minute; (2) Complete response (CR) on study days 2-7 (delayed CINV) is defined as the proportion of patients achieving a CR during the delayed time period. The data will be captured by the validated ultinational Association of Supportive Care in Cancer (MASCC) Anti-emesis Tool (MAT)/Osoba survey.
Outcome measures
| Measure |
Aprepitant+Ondansetron
n=70 Participants
On day 1, patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide). Additionally, On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.
Aprepitant: On day 1, eligible patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide).
Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen.
|
Ondansetron
n=66 Participants
On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.
Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen.
|
|---|---|---|
|
Proportion of Patients Achieving an Acute and Delayed Complete Response (CR)
Acute CINV CR
|
0.97 proportion of patients
|
0.88 proportion of patients
|
|
Proportion of Patients Achieving an Acute and Delayed Complete Response (CR)
Delayed CINV CR
|
0.59 proportion of patients
|
0.58 proportion of patients
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 2 patients in the Aprepitant + Ondansetron arm and 4 patients in the Ondansetron arm did not have adequate survey data for this analysis
Patients' global satisfaction with the antiemetic regimen is measured using the Osoba survey, which was administered on days 1-7. This survey asks patients "In the past 24 hours, did vomiting or dry heaves a) interfere with your appetite, b) affect your sleep, c) interfere with your physical activities, d) interfere with your social life, and e) interfere with your enjoyment of life?" Patients responded on a scale of 1-4 ranging from 'Not at all' to 'Very much.' Global satisfaction was defined as responding 'Not at all' for all questions related to vomiting/retching for each study day. The proportion of patients responding 'Not at all' for all Osoba vomiting/retching questions over the study period is reported.
Outcome measures
| Measure |
Aprepitant+Ondansetron
n=68 Participants
On day 1, patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide). Additionally, On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.
Aprepitant: On day 1, eligible patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide).
Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen.
|
Ondansetron
n=62 Participants
On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.
Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen.
|
|---|---|---|
|
Patient's Global Satisfaction With the Antiemetic Regimen
|
0.87 proportion of patients
|
0.81 proportion of patients
|
SECONDARY outcome
Timeframe: 7 daysPopulation: This analysis only includes those patients no achieving complete control (no emetic episode or need for rescue medication throughout the 7-day study period).
Median time in days to first emetic episode or first need of rescue medication, whichever occurred first as measured by the MAT/Osoba survey, among those patients experiencing an emetic episode or need of rescue medication
Outcome measures
| Measure |
Aprepitant+Ondansetron
n=29 Participants
On day 1, patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide). Additionally, On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.
Aprepitant: On day 1, eligible patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide).
Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen.
|
Ondansetron
n=30 Participants
On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.
Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen.
|
|---|---|---|
|
Time to Treatment Failure
|
5 days
Interval 1.0 to 7.0
|
4 days
Interval 1.0 to 7.0
|
Adverse Events
Aprepitant+Ondansetron
Serious events: 1 serious events
Other events: 57 other events
Deaths: 0 deaths
Ondansetron Alone
Serious events: 3 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aprepitant+Ondansetron
n=70 participants at risk
On day 1, patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide). Additionally, On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.
Aprepitant: On day 1, eligible patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide).
Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen.
|
Ondansetron Alone
n=66 participants at risk
On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.
Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen.
|
|---|---|---|
|
Nervous system disorders
Dysphasia
|
0.00%
0/70 • 30 days
|
1.5%
1/66 • 30 days
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Nervous system disorders
Nervous system disorders - Other, specify: R HEMIPLEGIA DUE TO DISEASE PROGRESSION
|
0.00%
0/70 • 30 days
|
1.5%
1/66 • 30 days
|
|
Nervous system disorders
Seizure
|
0.00%
0/70 • 30 days
|
3.0%
2/66 • 30 days
|
Other adverse events
| Measure |
Aprepitant+Ondansetron
n=70 participants at risk
On day 1, patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide). Additionally, On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.
Aprepitant: On day 1, eligible patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide).
Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen.
|
Ondansetron Alone
n=66 participants at risk
On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.
Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/70 • 30 days
|
1.5%
1/66 • 30 days
|
|
Ear and labyrinth disorders
Tinnitus
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
2/70 • 30 days
|
1.5%
1/66 • 30 days
|
|
Gastrointestinal disorders
Constipation
|
12.9%
9/70 • 30 days
|
10.6%
7/66 • 30 days
|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
2/70 • 30 days
|
1.5%
1/66 • 30 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/70 • 30 days
|
4.5%
3/66 • 30 days
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/70 • 30 days
|
1.5%
1/66 • 30 days
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: LIKELY VIRUS: DIARRHEA, FATIGUE, LOW GRADE FEVER
|
0.00%
0/70 • 30 days
|
1.5%
1/66 • 30 days
|
|
Gastrointestinal disorders
Nausea
|
52.9%
37/70 • 30 days
|
56.1%
37/66 • 30 days
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
7/70 • 30 days
|
7.6%
5/66 • 30 days
|
|
General disorders
Chills
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
General disorders
Edema limbs
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
General disorders
Fatigue
|
28.6%
20/70 • 30 days
|
19.7%
13/66 • 30 days
|
|
General disorders
Fever
|
1.4%
1/70 • 30 days
|
3.0%
2/66 • 30 days
|
|
General disorders
Non-cardiac chest pain
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
General disorders
Pain
|
0.00%
0/70 • 30 days
|
1.5%
1/66 • 30 days
|
|
Immune system disorders
Allergic reaction
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Infections and infestations
Sinusitis
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/70 • 30 days
|
1.5%
1/66 • 30 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/70 • 30 days
|
1.5%
1/66 • 30 days
|
|
Injury, poisoning and procedural complications
Fall
|
4.3%
3/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify: LACERATION REQUIRING STITCHES
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Investigations
Lymphocyte count decreased
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Investigations
Platelet count decreased
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Investigations
White blood cell decreased
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Metabolism and nutrition disorders
Anorexia
|
8.6%
6/70 • 30 days
|
10.6%
7/66 • 30 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.9%
2/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.4%
1/70 • 30 days
|
1.5%
1/66 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/70 • 30 days
|
1.5%
1/66 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.4%
1/70 • 30 days
|
1.5%
1/66 • 30 days
|
|
Nervous system disorders
Dizziness
|
2.9%
2/70 • 30 days
|
1.5%
1/66 • 30 days
|
|
Nervous system disorders
Dysgeusia
|
1.4%
1/70 • 30 days
|
1.5%
1/66 • 30 days
|
|
Nervous system disorders
Dysphasia
|
1.4%
1/70 • 30 days
|
1.5%
1/66 • 30 days
|
|
Nervous system disorders
Headache
|
8.6%
6/70 • 30 days
|
7.6%
5/66 • 30 days
|
|
Nervous system disorders
Nervous system disorders - Other, specify: DIFFICULTY WALKING AND GETTING UP FROM SITTING POSITION
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Nervous system disorders
Nervous system disorders - Other, specify: R FACIAL DROOP DUE TO DISEASE PROGRESSION
|
0.00%
0/70 • 30 days
|
1.5%
1/66 • 30 days
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/70 • 30 days
|
1.5%
1/66 • 30 days
|
|
Nervous system disorders
Seizure
|
4.3%
3/70 • 30 days
|
6.1%
4/66 • 30 days
|
|
Nervous system disorders
Tremor
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Psychiatric disorders
Anxiety
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Psychiatric disorders
Confusion
|
0.00%
0/70 • 30 days
|
1.5%
1/66 • 30 days
|
|
Psychiatric disorders
Insomnia
|
1.4%
1/70 • 30 days
|
3.0%
2/66 • 30 days
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/70 • 30 days
|
1.5%
1/66 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
1.4%
1/70 • 30 days
|
1.5%
1/66 • 30 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/70 • 30 days
|
1.5%
1/66 • 30 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.4%
1/70 • 30 days
|
3.0%
2/66 • 30 days
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: RASH TO CHEST; TEMO;UNRELATED TO EMEND
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: RASH; EMEND
|
1.4%
1/70 • 30 days
|
0.00%
0/66 • 30 days
|
|
Vascular disorders
Hot flashes
|
0.00%
0/70 • 30 days
|
1.5%
1/66 • 30 days
|
Additional Information
Mary Lou Affronti, DNP, RN, MHSc, ANP
Duke University Medical Center
Phone: 9196845301
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place