Trial Outcomes & Findings for Effect of Proactive Management of Side Effects on Treatment Compliance in Malignant Melanoma Patients on High-dose Intron A Therapy (Study P04600) (NCT NCT00723710)
NCT ID: NCT00723710
Last Updated: 2015-08-26
Results Overview
Treatment completion was defined as those who completed both the induction and maintenance phases.
Recruitment status
COMPLETED
Target enrollment
299 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2015-08-26
Participant Flow
299 participants were enrolled. Of these, 294 were considered efficacy evaluable (5 participants were excluded from efficacy analyses: 2 moved, 1 required radiation, 1 not eligible and 1 missing data).
Participant milestones
| Measure |
Intron A
The recommended regimen included an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 million international units per square meter (MIU/m\^2). The induction treatment was followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m\^2. Therapy was administered for a total of one year unless the disease progressed or the treatment led to recurrent unmanageable serious adverse effects.
|
|---|---|
|
Overall Study
STARTED
|
294
|
|
Overall Study
COMPLETED
|
120
|
|
Overall Study
NOT COMPLETED
|
174
|
Reasons for withdrawal
| Measure |
Intron A
The recommended regimen included an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 million international units per square meter (MIU/m\^2). The induction treatment was followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m\^2. Therapy was administered for a total of one year unless the disease progressed or the treatment led to recurrent unmanageable serious adverse effects.
|
|---|---|
|
Overall Study
Disease progression
|
48
|
|
Overall Study
Adverse Event
|
88
|
|
Overall Study
Withdrawal by Subject
|
36
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Effect of Proactive Management of Side Effects on Treatment Compliance in Malignant Melanoma Patients on High-dose Intron A Therapy (Study P04600)
Baseline characteristics by cohort
| Measure |
Intron A
n=294 Participants
The recommended regimen included an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 MIU/m\^2. The induction treatment was followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m\^2. Therapy was administered for a total of one year unless the disease progressed or the treatment led to recurrent unmanageable serious adverse effects.
|
|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
170 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: The number of participants who started the induction phase
Treatment completion was defined as those who completed both the induction and maintenance phases.
Outcome measures
| Measure |
Intron A
n=294 Participants
The recommended regimen included an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 MIU/m\^2. The induction treatment was followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m\^2. Therapy was administered for a total of one year unless the disease progressed or the treatment led to recurrent unmanageable serious adverse effects.
|
|---|---|
|
Number of Participants Who Completed Treatment
|
120 Participants
|
Adverse Events
Intron-A
Serious events: 21 serious events
Other events: 297 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intron-A
n=299 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
Eye disorders
VISUAL IMPAIRMENT
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
Gastrointestinal disorders
NAUSEA
|
0.67%
2/299 • Number of events 2
Population was all enrolled participants (299).
|
|
Gastrointestinal disorders
VOMITING
|
0.67%
2/299 • Number of events 2
Population was all enrolled participants (299).
|
|
General disorders
CHILLS
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
General disorders
FATIGUE
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
General disorders
INFUSION SITE SWELLING
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
General disorders
PYREXIA
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
Infections and infestations
CELLULITIS
|
0.67%
2/299 • Number of events 2
Population was all enrolled participants (299).
|
|
Infections and infestations
GROIN ABSCESS
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
Infections and infestations
PNEUMONIA
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
Infections and infestations
SINUSITIS
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
Injury, poisoning and procedural complications
SEROMA
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.67%
2/299 • Number of events 2
Population was all enrolled participants (299).
|
|
Musculoskeletal and connective tissue disorders
PRIMARY SEQUESTRUM
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
FEMALE REPRODUCTIVE NEOPLASM
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
|
0.67%
2/299 • Number of events 2
Population was all enrolled participants (299).
|
|
Nervous system disorders
DIZZINESS
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
Nervous system disorders
GRAND MAL CONVULSION
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
Nervous system disorders
HEADACHE
|
1.0%
3/299 • Number of events 3
Population was all enrolled participants (299).
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
Psychiatric disorders
DEPRESSION
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
Psychiatric disorders
OBSESSIVE-COMPULSIVE DISORDER
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
Respiratory, thoracic and mediastinal disorders
THROAT TIGHTNESS
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.33%
1/299 • Number of events 1
Population was all enrolled participants (299).
|
Other adverse events
| Measure |
Intron-A
n=299 participants at risk
|
|---|---|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
39.1%
117/299 • Number of events 155
Population was all enrolled participants (299).
|
|
Investigations
WEIGHT DECREASED
|
8.7%
26/299 • Number of events 29
Population was all enrolled participants (299).
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
26.8%
80/299 • Number of events 105
Population was all enrolled participants (299).
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
28.1%
84/299 • Number of events 102
Population was all enrolled participants (299).
|
|
Nervous system disorders
DIZZINESS
|
6.0%
18/299 • Number of events 24
Population was all enrolled participants (299).
|
|
Nervous system disorders
DYSGEUSIA
|
16.7%
50/299 • Number of events 60
Population was all enrolled participants (299).
|
|
Nervous system disorders
HEADACHE
|
48.5%
145/299 • Number of events 215
Population was all enrolled participants (299).
|
|
Psychiatric disorders
ANXIETY
|
6.7%
20/299 • Number of events 22
Population was all enrolled participants (299).
|
|
Psychiatric disorders
DEPRESSION
|
32.4%
97/299 • Number of events 102
Population was all enrolled participants (299).
|
|
Psychiatric disorders
INSOMNIA
|
9.4%
28/299 • Number of events 36
Population was all enrolled participants (299).
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
11.0%
33/299 • Number of events 41
Population was all enrolled participants (299).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
7.0%
21/299 • Number of events 22
Population was all enrolled participants (299).
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
9.7%
29/299 • Number of events 29
Population was all enrolled participants (299).
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
6.4%
19/299 • Number of events 20
Population was all enrolled participants (299).
|
|
Skin and subcutaneous tissue disorders
RASH
|
12.0%
36/299 • Number of events 43
Population was all enrolled participants (299).
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
23.1%
69/299 • Number of events 114
Population was all enrolled participants (299).
|
|
Gastrointestinal disorders
CONSTIPATION
|
10.7%
32/299 • Number of events 37
Population was all enrolled participants (299).
|
|
Gastrointestinal disorders
DIARRHOEA
|
20.1%
60/299 • Number of events 81
Population was all enrolled participants (299).
|
|
Gastrointestinal disorders
DRY MOUTH
|
6.0%
18/299 • Number of events 21
Population was all enrolled participants (299).
|
|
Gastrointestinal disorders
DYSPEPSIA
|
6.0%
18/299 • Number of events 19
Population was all enrolled participants (299).
|
|
Gastrointestinal disorders
NAUSEA
|
53.2%
159/299 • Number of events 224
Population was all enrolled participants (299).
|
|
Gastrointestinal disorders
VOMITING
|
22.7%
68/299 • Number of events 88
Population was all enrolled participants (299).
|
|
General disorders
ASTHENIA
|
5.7%
17/299 • Number of events 23
Population was all enrolled participants (299).
|
|
General disorders
CHILLS
|
11.7%
35/299 • Number of events 56
Population was all enrolled participants (299).
|
|
General disorders
FATIGUE
|
63.2%
189/299 • Number of events 275
Population was all enrolled participants (299).
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
73.6%
220/299 • Number of events 256
Population was all enrolled participants (299).
|
|
General disorders
PYREXIA
|
28.8%
86/299 • Number of events 103
Population was all enrolled participants (299).
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place