Trial Outcomes & Findings for Dose-finding Study of APD403 to Prevent Nausea and Vomiting After Chemotherapy (NCT NCT01857232)
NCT ID: NCT01857232
Last Updated: 2020-11-25
Results Overview
Delayed phase complete response (CR), defined as an absence of emetic episodes and no rescue medication use in the period from 24 to 120 hours after the initiation of chemotherapy. The primary endpoint was analysed separately in the strata of chemotherapy regimen and gender, and in the strata of country.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
342 participants
Primary outcome timeframe
24-120 hours
Results posted on
2020-11-25
Participant Flow
Participant milestones
| Measure |
Control
ACUTE (day 1): IV OND + FOS + DEX
• DELAYED (days 2 to 4): Oral DEX
|
Placebo
ACUTE (day 1): IV OND + APD403 20 mg DELAYED (days 2 to 4): Oral Placebo
|
APD403 10MG
ACUTE (day 1): IV OND + APD403 20 mg
• DELAYED (days 2 to 4): Oral APD403 10 mg
|
APD403 20MG
ACUTE (day 1): IV OND + APD403 20 mg
• DELAYED (days 2 to 4): Oral APD403 20 mg
|
ADP403 40MG
ACUTE (day 1): IV OND + APD403 20 mg
• DELAYED (days 2 to 4): Oral APD403 40 mg
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
69
|
67
|
67
|
70
|
69
|
|
Overall Study
Evaluable ITT
|
66
|
66
|
63
|
68
|
65
|
|
Overall Study
COMPLETED
|
61
|
65
|
63
|
68
|
63
|
|
Overall Study
NOT COMPLETED
|
8
|
2
|
4
|
2
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose-finding Study of APD403 to Prevent Nausea and Vomiting After Chemotherapy
Baseline characteristics by cohort
| Measure |
Control ( Dexamethazon)
n=66 Participants
ACUTE (day 1): IV OND + FOS + DEX
• DELAYED (days 2 to 4): Oral DEX
|
Placebo
n=66 Participants
ACUTE (day 1): IV OND + APD403 20 mg DELAYED (days 2 to 4): Oral Placebo
|
APD403 10MG
n=63 Participants
ACUTE (day 1): IV OND + APD403 20 mg
• DELAYED (days 2 to 4): Oral APD403 10 mg
|
APD403 20MG
n=68 Participants
ACUTE (day 1): IV OND + APD403 20 mg
• DELAYED (days 2 to 4): Oral APD403 20 mg
|
ADP403 40MG
n=65 Participants
ACUTE (day 1): IV OND + APD403 20 mg
• DELAYED (days 2 to 4): Oral APD403 40 mg
|
Total
n=328 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Region of Enrollment
United Kingdom
|
27 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
147 Participants
n=8 Participants
|
|
Age, Continuous
|
58.1 Years
STANDARD_DEVIATION 10.38 • n=5 Participants
|
57.3 Years
STANDARD_DEVIATION 11.01 • n=7 Participants
|
56.9 Years
STANDARD_DEVIATION 11.24 • n=5 Participants
|
56.6 Years
STANDARD_DEVIATION 10.53 • n=4 Participants
|
56.5 Years
STANDARD_DEVIATION 10.59 • n=21 Participants
|
57.1 Years
STANDARD_DEVIATION 10.70 • n=8 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
257 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
71 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
323 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Region of Enrollment
Denmark
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
73 Participants
n=8 Participants
|
|
Region of Enrollment
Germany
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
108 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 24-120 hoursPopulation: ITT
Delayed phase complete response (CR), defined as an absence of emetic episodes and no rescue medication use in the period from 24 to 120 hours after the initiation of chemotherapy. The primary endpoint was analysed separately in the strata of chemotherapy regimen and gender, and in the strata of country.
Outcome measures
| Measure |
Control
n=66 Participants
ACUTE (day 1): IV OND + FOS + DEX
• DELAYED (days 2 to 4): Oral DEX
|
PLACEBO
n=66 Participants
ACUTE (day 1): IV OND + APD403 20 mg
• DELAYED (days 2 to 4): Oral Placebo
|
APD403 10MG
n=63 Participants
ACUTE (day 1): IV OND + APD403 20 mg
• DELAYED (days 2 to 4): Oral APD403 10 mg
|
ADP421 20MG
n=68 Participants
ACUTE (day 1): IV OND + APD403 20 mg
• DELAYED (days 2 to 4): Oral APD403 20 mg
|
APD421 40MG
n=65 Participants
ACUTE (day 1): IV OND + APD403 20 mg
• DELAYED (days 2 to 4): Oral APD403 40 mg
|
|---|---|---|---|---|---|
|
Number of Participants With Delayed Phase Complete Response(CR)
|
37 Participants
|
13 Participants
|
27 Participants
|
21 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 0 to 120 hours after the initiation of chemotherapyCR defined as no emesis and no use of rescue medication, in the overall phase (0 to 120 hours after the initiation of chemotherapy)
Outcome measures
| Measure |
Control
n=66 Participants
ACUTE (day 1): IV OND + FOS + DEX
• DELAYED (days 2 to 4): Oral DEX
|
PLACEBO
n=66 Participants
ACUTE (day 1): IV OND + APD403 20 mg
• DELAYED (days 2 to 4): Oral Placebo
|
APD403 10MG
n=63 Participants
ACUTE (day 1): IV OND + APD403 20 mg
• DELAYED (days 2 to 4): Oral APD403 10 mg
|
ADP421 20MG
n=68 Participants
ACUTE (day 1): IV OND + APD403 20 mg
• DELAYED (days 2 to 4): Oral APD403 20 mg
|
APD421 40MG
n=65 Participants
ACUTE (day 1): IV OND + APD403 20 mg
• DELAYED (days 2 to 4): Oral APD403 40 mg
|
|---|---|---|---|---|---|
|
Number of Participants With CR in the Overall Phase.
|
33 Participants
|
11 Participants
|
21 Participants
|
17 Participants
|
17 Participants
|
Adverse Events
Control
Serious events: 8 serious events
Other events: 36 other events
Deaths: 2 deaths
Placebo
Serious events: 12 serious events
Other events: 47 other events
Deaths: 0 deaths
APD403 10MG
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
APD403 20MG
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
ADP403 40MG
Serious events: 4 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=66 participants at risk
ACUTE (day 1): IV OND + FOS + DEX
• DELAYED (days 2 to 4): Oral DEX
|
Placebo
n=66 participants at risk
ACUTE (day 1): IV OND + APD403 20 mg DELAYED (days 2 to 4): Oral Placebo
|
APD403 10MG
n=63 participants at risk
ACUTE (day 1): IV OND + APD403 20 mg
• DELAYED (days 2 to 4): Oral APD403 10 mg
|
APD403 20MG
n=68 participants at risk
ACUTE (day 1): IV OND + APD403 20 mg
• DELAYED (days 2 to 4): Oral APD403 20 mg
|
ADP403 40MG
n=65 participants at risk
ACUTE (day 1): IV OND + APD403 20 mg
• DELAYED (days 2 to 4): Oral APD403 40 mg
|
|---|---|---|---|---|---|
|
General disorders
Chest Pain
|
0.00%
0/66 • 7 Days
|
1.5%
1/66 • Number of events 1 • 7 Days
|
0.00%
0/63 • 7 Days
|
0.00%
0/68 • 7 Days
|
1.5%
1/65 • Number of events 1 • 7 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/66 • 7 Days
|
0.00%
0/66 • 7 Days
|
0.00%
0/63 • 7 Days
|
0.00%
0/68 • 7 Days
|
1.5%
1/65 • Number of events 1 • 7 Days
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/66 • Number of events 1 • 7 Days
|
6.1%
4/66 • Number of events 4 • 7 Days
|
1.6%
1/63 • Number of events 1 • 7 Days
|
1.5%
1/68 • Number of events 1 • 7 Days
|
0.00%
0/65 • 7 Days
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/66 • Number of events 1 • 7 Days
|
1.5%
1/66 • Number of events 1 • 7 Days
|
0.00%
0/63 • 7 Days
|
1.5%
1/68 • Number of events 1 • 7 Days
|
0.00%
0/65 • 7 Days
|
|
Investigations
Electrocardiogram QT Prolonged
|
0.00%
0/66 • 7 Days
|
0.00%
0/66 • 7 Days
|
0.00%
0/63 • 7 Days
|
1.5%
1/68 • Number of events 1 • 7 Days
|
0.00%
0/65 • 7 Days
|
|
Investigations
Blood Creatine Increase
|
0.00%
0/66 • 7 Days
|
0.00%
0/66 • 7 Days
|
0.00%
0/63 • 7 Days
|
1.5%
1/68 • Number of events 1 • 7 Days
|
0.00%
0/65 • 7 Days
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/66 • 7 Days
|
1.5%
1/66 • Number of events 1 • 7 Days
|
1.6%
1/63 • Number of events 1 • 7 Days
|
0.00%
0/68 • 7 Days
|
0.00%
0/65 • 7 Days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/66 • 7 Days
|
1.5%
1/66 • Number of events 1 • 7 Days
|
0.00%
0/63 • 7 Days
|
0.00%
0/68 • 7 Days
|
0.00%
0/65 • 7 Days
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/66 • 7 Days
|
1.5%
1/66 • Number of events 1 • 7 Days
|
0.00%
0/63 • 7 Days
|
0.00%
0/68 • 7 Days
|
0.00%
0/65 • 7 Days
|
|
General disorders
Pyrexia
|
0.00%
0/66 • 7 Days
|
3.0%
2/66 • Number of events 2 • 7 Days
|
0.00%
0/63 • 7 Days
|
0.00%
0/68 • 7 Days
|
0.00%
0/65 • 7 Days
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/66 • 7 Days
|
1.5%
1/66 • Number of events 1 • 7 Days
|
0.00%
0/63 • 7 Days
|
0.00%
0/68 • 7 Days
|
0.00%
0/65 • 7 Days
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.0%
2/66 • Number of events 2 • 7 Days
|
0.00%
0/66 • 7 Days
|
0.00%
0/63 • 7 Days
|
0.00%
0/68 • 7 Days
|
0.00%
0/65 • 7 Days
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.5%
1/66 • Number of events 1 • 7 Days
|
0.00%
0/66 • 7 Days
|
0.00%
0/63 • 7 Days
|
0.00%
0/68 • 7 Days
|
0.00%
0/65 • 7 Days
|
|
Gastrointestinal disorders
Duodenal Obstruction
|
1.5%
1/66 • Number of events 1 • 7 Days
|
0.00%
0/66 • 7 Days
|
0.00%
0/63 • 7 Days
|
0.00%
0/68 • 7 Days
|
0.00%
0/65 • 7 Days
|
|
Infections and infestations
Neutropenic sepsis
|
1.5%
1/66 • Number of events 1 • 7 Days
|
0.00%
0/66 • 7 Days
|
0.00%
0/63 • 7 Days
|
0.00%
0/68 • 7 Days
|
3.1%
2/65 • Number of events 2 • 7 Days
|
|
Cardiac disorders
Cardiac arrest
|
1.5%
1/66 • Number of events 1 • 7 Days
|
0.00%
0/66 • 7 Days
|
0.00%
0/63 • 7 Days
|
0.00%
0/68 • 7 Days
|
0.00%
0/65 • 7 Days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.5%
1/66 • Number of events 1 • 7 Days
|
0.00%
0/66 • 7 Days
|
0.00%
0/63 • 7 Days
|
0.00%
0/68 • 7 Days
|
0.00%
0/65 • 7 Days
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.5%
1/66 • Number of events 1 • 7 Days
|
0.00%
0/66 • 7 Days
|
0.00%
0/63 • 7 Days
|
0.00%
0/68 • 7 Days
|
0.00%
0/65 • 7 Days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
1/66 • Number of events 1 • 7 Days
|
0.00%
0/66 • 7 Days
|
0.00%
0/63 • 7 Days
|
0.00%
0/68 • 7 Days
|
0.00%
0/65 • 7 Days
|
|
Investigations
Blood Prolactin Increased
|
1.5%
1/66 • Number of events 1 • 7 Days
|
1.5%
1/66 • Number of events 1 • 7 Days
|
0.00%
0/63 • 7 Days
|
0.00%
0/68 • 7 Days
|
0.00%
0/65 • 7 Days
|
|
Investigations
General Physical Condition Abnormal
|
0.00%
0/66 • 7 Days
|
1.5%
1/66 • Number of events 1 • 7 Days
|
0.00%
0/63 • 7 Days
|
0.00%
0/68 • 7 Days
|
0.00%
0/65 • 7 Days
|
Other adverse events
| Measure |
Control
n=66 participants at risk
ACUTE (day 1): IV OND + FOS + DEX
• DELAYED (days 2 to 4): Oral DEX
|
Placebo
n=66 participants at risk
ACUTE (day 1): IV OND + APD403 20 mg DELAYED (days 2 to 4): Oral Placebo
|
APD403 10MG
n=63 participants at risk
ACUTE (day 1): IV OND + APD403 20 mg
• DELAYED (days 2 to 4): Oral APD403 10 mg
|
APD403 20MG
n=68 participants at risk
ACUTE (day 1): IV OND + APD403 20 mg
• DELAYED (days 2 to 4): Oral APD403 20 mg
|
ADP403 40MG
n=65 participants at risk
ACUTE (day 1): IV OND + APD403 20 mg
• DELAYED (days 2 to 4): Oral APD403 40 mg
|
|---|---|---|---|---|---|
|
General disorders
Fatigue
|
19.7%
13/66 • Number of events 13 • 7 Days
|
19.7%
13/66 • Number of events 13 • 7 Days
|
20.6%
13/63 • Number of events 13 • 7 Days
|
7.4%
5/68 • Number of events 5 • 7 Days
|
16.9%
11/65 • Number of events 11 • 7 Days
|
|
General disorders
Pyrexia
|
3.0%
2/66 • Number of events 2 • 7 Days
|
6.1%
4/66 • Number of events 4 • 7 Days
|
0.00%
0/63 • 7 Days
|
1.5%
1/68 • Number of events 1 • 7 Days
|
0.00%
0/65 • 7 Days
|
|
Gastrointestinal disorders
Constipation
|
6.1%
4/66 • Number of events 4 • 7 Days
|
7.6%
5/66 • Number of events 5 • 7 Days
|
11.1%
7/63 • Number of events 7 • 7 Days
|
2.9%
2/68 • Number of events 2 • 7 Days
|
3.1%
2/65 • Number of events 2 • 7 Days
|
|
Gastrointestinal disorders
Diarrhoea
|
6.1%
4/66 • Number of events 4 • 7 Days
|
9.1%
6/66 • Number of events 7 • 7 Days
|
4.8%
3/63 • Number of events 3 • 7 Days
|
2.9%
2/68 • Number of events 3 • 7 Days
|
3.1%
2/65 • Number of events 2 • 7 Days
|
|
Gastrointestinal disorders
Nausea
|
3.0%
2/66 • Number of events 2 • 7 Days
|
6.1%
4/66 • Number of events 4 • 7 Days
|
1.6%
1/63 • Number of events 1 • 7 Days
|
1.5%
1/68 • Number of events 1 • 7 Days
|
0.00%
0/65 • 7 Days
|
|
Gastrointestinal disorders
Dyspepsia
|
3.0%
2/66 • Number of events 2 • 7 Days
|
6.1%
4/66 • Number of events 4 • 7 Days
|
0.00%
0/63 • 7 Days
|
0.00%
0/68 • 7 Days
|
1.5%
1/65 • Number of events 1 • 7 Days
|
|
General disorders
Mucosal Dryness
|
1.5%
1/66 • Number of events 1 • 7 Days
|
1.5%
1/66 • Number of events 1 • 7 Days
|
1.6%
1/63 • Number of events 1 • 7 Days
|
4.4%
3/68 • Number of events 3 • 7 Days
|
6.2%
4/65 • Number of events 4 • 7 Days
|
|
Nervous system disorders
Headache
|
6.1%
4/66 • Number of events 4 • 7 Days
|
13.6%
9/66 • Number of events 9 • 7 Days
|
11.1%
7/63 • Number of events 7 • 7 Days
|
4.4%
3/68 • Number of events 3 • 7 Days
|
12.3%
8/65 • Number of events 8 • 7 Days
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
6.1%
4/66 • Number of events 4 • 7 Days
|
3.0%
2/66 • Number of events 2 • 7 Days
|
3.2%
2/63 • Number of events 2 • 7 Days
|
5.9%
4/68 • Number of events 4 • 7 Days
|
0.00%
0/65 • 7 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60