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Dose-finding Study of APD403 to Prevent Nausea and Vomiting After Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01857232
Recruitment Status : Completed
First Posted : May 20, 2013
Results First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Acacia Pharma Ltd

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition CINV
Interventions Drug: Ondansetron
Drug: Placebo
Drug: Dexamethasone
Drug: Fosaprepitant
Drug: APD403 IV
Drug: APD403 oral
Enrollment 342
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Placebo APD403 10MG APD403 20MG ADP403 40MG
Hide Arm/Group Description

ACUTE (day 1): IV OND + FOS + DEX

• DELAYED (days 2 to 4): Oral DEX

ACUTE (day 1): IV OND + APD403 20 mg DELAYED (days 2 to 4): Oral Placebo

ACUTE (day 1): IV OND + APD403 20 mg

• DELAYED (days 2 to 4): Oral APD403 10 mg

ACUTE (day 1): IV OND + APD403 20 mg

• DELAYED (days 2 to 4): Oral APD403 20 mg

ACUTE (day 1): IV OND + APD403 20 mg

• DELAYED (days 2 to 4): Oral APD403 40 mg

Period Title: Overall Study
Started 69 67 67 70 69
Evaluable ITT 66 66 63 68 65
Completed 61 65 63 68 63
Not Completed 8 2 4 2 6
Arm/Group Title Control ( Dexamethazon) Placebo APD403 10MG APD403 20MG ADP403 40MG Total
Hide Arm/Group Description

ACUTE (day 1): IV OND + FOS + DEX

• DELAYED (days 2 to 4): Oral DEX

ACUTE (day 1): IV OND + APD403 20 mg DELAYED (days 2 to 4): Oral Placebo

ACUTE (day 1): IV OND + APD403 20 mg

• DELAYED (days 2 to 4): Oral APD403 10 mg

ACUTE (day 1): IV OND + APD403 20 mg

• DELAYED (days 2 to 4): Oral APD403 20 mg

ACUTE (day 1): IV OND + APD403 20 mg

• DELAYED (days 2 to 4): Oral APD403 40 mg

Total of all reporting groups
Overall Number of Baseline Participants 66 66 63 68 65 328
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 66 participants 63 participants 68 participants 65 participants 328 participants
58.1  (10.38) 57.3  (11.01) 56.9  (11.24) 56.6  (10.53) 56.5  (10.59) 57.1  (10.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 66 participants 63 participants 68 participants 65 participants 328 participants
Female
51
  77.3%
51
  77.3%
52
  82.5%
52
  76.5%
51
  78.5%
257
  78.4%
Male
15
  22.7%
15
  22.7%
11
  17.5%
16
  23.5%
14
  21.5%
71
  21.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 66 participants 63 participants 68 participants 65 participants 328 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
65
  98.5%
64
  97.0%
62
  98.4%
68
 100.0%
64
  98.5%
323
  98.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.5%
2
   3.0%
1
   1.6%
0
   0.0%
1
   1.5%
5
   1.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 66 participants 63 participants 68 participants 65 participants 328 participants
Denmark 16 12 13 17 15 73
Germany 23 23 19 21 22 108
United Kingdom 27 31 31 30 28 147
1.Primary Outcome
Title Number of Participants With Delayed Phase Complete Response(CR)
Hide Description

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.

Time Frame 24-120 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Control PLACEBO APD403 10MG ADP421 20MG APD421 40MG
Hide Arm/Group Description:

ACUTE (day 1): IV OND + FOS + DEX

• DELAYED (days 2 to 4): Oral DEX

ACUTE (day 1): IV OND + APD403 20 mg

• DELAYED (days 2 to 4): Oral Placebo

ACUTE (day 1): IV OND + APD403 20 mg

• DELAYED (days 2 to 4): Oral APD403 10 mg

ACUTE (day 1): IV OND + APD403 20 mg

• DELAYED (days 2 to 4): Oral APD403 20 mg

ACUTE (day 1): IV OND + APD403 20 mg

• DELAYED (days 2 to 4): Oral APD403 40 mg

Overall Number of Participants Analyzed 66 66 63 68 65
Measure Type: Count of Participants
Unit of Measure: Participants
37
  56.1%
13
  19.7%
27
  42.9%
21
  30.9%
20
  30.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PLACEBO, APD403 10MG
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PLACEBO, ADP421 20MG
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0987
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PLACEBO, APD421 40MG
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1041
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With CR in the Overall Phase.
Hide Description CR defined as no emesis and no use of rescue medication, in the overall phase (0 to 120 hours after the initiation of chemotherapy)
Time Frame 0 to 120 hours after the initiation of chemotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Placebo APD403 10MG APD403 20MG ADP403 40MG
Hide Arm/Group Description:

ACUTE (day 1): IV OND + FOS + DEX

• DELAYED (days 2 to 4): Oral DEX

ACUTE (day 1): IV OND + APD403 20 mg DELAYED (days 2 to 4): Oral Placebo

ACUTE (day 1): IV OND + APD403 20 mg

• DELAYED (days 2 to 4): Oral APD403 10 mg

ACUTE (day 1): IV OND + APD403 20 mg

• DELAYED (days 2 to 4): Oral APD403 20 mg

ACUTE (day 1): IV OND + APD403 20 mg

• DELAYED (days 2 to 4): Oral APD403 40 mg

Overall Number of Participants Analyzed 66 66 63 68 65
Measure Type: Count of Participants
Unit of Measure: Participants
33
  50.0%
11
  16.7%
21
  33.3%
17
  25.0%
17
  26.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, APD403 10MG
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0235
Comments [Not Specified]
Method Chi-squared, Corrected
Comments 1-sided
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, APD403 20MG
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1651
Comments [Not Specified]
Method Chi-squared, Corrected
Comments 1-sided
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, ADP403 40MG
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1332
Comments [Not Specified]
Method Chi-squared, Corrected
Comments 1-sided
Time Frame 7 Days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Placebo APD403 10MG APD403 20MG ADP403 40MG
Hide Arm/Group Description

ACUTE (day 1): IV OND + FOS + DEX

• DELAYED (days 2 to 4): Oral DEX

ACUTE (day 1): IV OND + APD403 20 mg DELAYED (days 2 to 4): Oral Placebo

ACUTE (day 1): IV OND + APD403 20 mg

• DELAYED (days 2 to 4): Oral APD403 10 mg

ACUTE (day 1): IV OND + APD403 20 mg

• DELAYED (days 2 to 4): Oral APD403 20 mg

ACUTE (day 1): IV OND + APD403 20 mg

• DELAYED (days 2 to 4): Oral APD403 40 mg

All-Cause Mortality
Control Placebo APD403 10MG APD403 20MG ADP403 40MG
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/66 (3.03%)      0/66 (0.00%)      0/63 (0.00%)      0/68 (0.00%)      0/65 (0.00%)    
Hide Serious Adverse Events
Control Placebo APD403 10MG APD403 20MG ADP403 40MG
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/66 (12.12%)      12/66 (18.18%)      2/63 (3.17%)      3/68 (4.41%)      4/65 (6.15%)    
Blood and lymphatic system disorders           
Febrile Neutropenia  1  2/66 (3.03%)  2 0/66 (0.00%)  0 0/63 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0
Pancytopenia  1  1/66 (1.52%)  1 0/66 (0.00%)  0 0/63 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0
Cardiac disorders           
Cardiac arrest  1  1/66 (1.52%)  1 0/66 (0.00%)  0 0/63 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0
Gastrointestinal disorders           
Nausea  1  1/66 (1.52%)  1 4/66 (6.06%)  4 1/63 (1.59%)  1 1/68 (1.47%)  1 0/65 (0.00%)  0
Vomiting  1  1/66 (1.52%)  1 1/66 (1.52%)  1 0/63 (0.00%)  0 1/68 (1.47%)  1 0/65 (0.00%)  0
Duodenal Obstruction  1  1/66 (1.52%)  1 0/66 (0.00%)  0 0/63 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0
General disorders           
Chest Pain  1  0/66 (0.00%)  0 1/66 (1.52%)  1 0/63 (0.00%)  0 0/68 (0.00%)  0 1/65 (1.54%)  1
Pyrexia  1  0/66 (0.00%)  0 2/66 (3.03%)  2 0/63 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0
Infections and infestations           
Urinary Tract Infection  1  0/66 (0.00%)  0 1/66 (1.52%)  1 0/63 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0
Neutropenic sepsis  1  1/66 (1.52%)  1 0/66 (0.00%)  0 0/63 (0.00%)  0 0/68 (0.00%)  0 2/65 (3.08%)  2
Injury, poisoning and procedural complications           
Infusion related reaction  1  1/66 (1.52%)  1 0/66 (0.00%)  0 0/63 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0
Investigations           
Electrocardiogram QT Prolonged  1  0/66 (0.00%)  0 0/66 (0.00%)  0 0/63 (0.00%)  0 1/68 (1.47%)  1 0/65 (0.00%)  0
Blood Creatine Increase  1  0/66 (0.00%)  0 0/66 (0.00%)  0 0/63 (0.00%)  0 1/68 (1.47%)  1 0/65 (0.00%)  0
Blood Prolactin Increased  1  1/66 (1.52%)  1 1/66 (1.52%)  1 0/63 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0
General Physical Condition Abnormal  1  0/66 (0.00%)  0 1/66 (1.52%)  1 0/63 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0
Nervous system disorders           
Dizziness  1  0/66 (0.00%)  0 1/66 (1.52%)  1 0/63 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0
Psychiatric disorders           
Nervousness  1  0/66 (0.00%)  0 1/66 (1.52%)  1 0/63 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0
Renal and urinary disorders           
Renal Failure  1  0/66 (0.00%)  0 1/66 (1.52%)  1 1/63 (1.59%)  1 0/68 (0.00%)  0 0/65 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Pulmonary Embolism  1  0/66 (0.00%)  0 0/66 (0.00%)  0 0/63 (0.00%)  0 0/68 (0.00%)  0 1/65 (1.54%)  1
Haemoptysis  1  1/66 (1.52%)  1 0/66 (0.00%)  0 0/63 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0
Dyspnoea  1  1/66 (1.52%)  1 0/66 (0.00%)  0 0/63 (0.00%)  0 0/68 (0.00%)  0 0/65 (0.00%)  0
1
Term from vocabulary, MedDRA 16.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
Control Placebo APD403 10MG APD403 20MG ADP403 40MG
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/66 (54.55%)      47/66 (71.21%)      34/63 (53.97%)      21/68 (30.88%)      28/65 (43.08%)    
Gastrointestinal disorders           
Constipation  1  4/66 (6.06%)  4 5/66 (7.58%)  5 7/63 (11.11%)  7 2/68 (2.94%)  2 2/65 (3.08%)  2
Diarrhoea  1  4/66 (6.06%)  4 6/66 (9.09%)  7 3/63 (4.76%)  3 2/68 (2.94%)  3 2/65 (3.08%)  2
Nausea  1  2/66 (3.03%)  2 4/66 (6.06%)  4 1/63 (1.59%)  1 1/68 (1.47%)  1 0/65 (0.00%)  0
Dyspepsia  1  2/66 (3.03%)  2 4/66 (6.06%)  4 0/63 (0.00%)  0 0/68 (0.00%)  0 1/65 (1.54%)  1
General disorders           
Fatigue  1  13/66 (19.70%)  13 13/66 (19.70%)  13 13/63 (20.63%)  13 5/68 (7.35%)  5 11/65 (16.92%)  11
Pyrexia  1  2/66 (3.03%)  2 4/66 (6.06%)  4 0/63 (0.00%)  0 1/68 (1.47%)  1 0/65 (0.00%)  0
Mucosal Dryness  1  1/66 (1.52%)  1 1/66 (1.52%)  1 1/63 (1.59%)  1 3/68 (4.41%)  3 4/65 (6.15%)  4
Metabolism and nutrition disorders           
Decreased Appetite  1  4/66 (6.06%)  4 2/66 (3.03%)  2 2/63 (3.17%)  2 4/68 (5.88%)  4 0/65 (0.00%)  0
Nervous system disorders           
Headache  1  4/66 (6.06%)  4 9/66 (13.64%)  9 7/63 (11.11%)  7 3/68 (4.41%)  3 8/65 (12.31%)  8
1
Term from vocabulary, MedDRA 16.1
Indicates events were collected by systematic assessment
There were no limitations and caveats with this study
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Gabriel Fox
Organization: Acacia Pharma Ltd
Phone: +44-(0)1223-875149 ext 149
EMail: GabrielFox@acaciapharma.com
Layout table for additonal information
Responsible Party: Acacia Pharma Ltd
ClinicalTrials.gov Identifier: NCT01857232    
Other Study ID Numbers: DN10016
First Submitted: May 16, 2013
First Posted: May 20, 2013
Results First Submitted: November 27, 2018
Results First Posted: March 12, 2019
Last Update Posted: March 12, 2019