Trial Outcomes & Findings for An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies (NCT NCT00226655)
NCT ID: NCT00226655
Last Updated: 2012-08-31
Results Overview
Number of patients reporting adverse events
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
112 participants
Primary outcome timeframe
Prospective
Results posted on
2012-08-31
Participant Flow
Recruitment started February 2005;
Patients rolled-over from previous placebo controlled studies; open label study so no group assignment
Participant milestones
| Measure |
hCRF
All patients will receive hCRF (XERECEPT) 2mg/day
|
|---|---|
|
Overall Study
STARTED
|
112
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
79
|
Reasons for withdrawal
| Measure |
hCRF
All patients will receive hCRF (XERECEPT) 2mg/day
|
|---|---|
|
Overall Study
Death
|
13
|
|
Overall Study
Withdrawal by Subject
|
15
|
|
Overall Study
Adverse Event
|
35
|
|
Overall Study
Physician Decision
|
6
|
|
Overall Study
Clinical deterioration
|
10
|
Baseline Characteristics
An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies
Baseline characteristics by cohort
| Measure |
hCRF
n=112 Participants
All patients will receive hCRF (XERECEPT) 2mg/day
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
101 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Age Continuous
|
51.4 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
101 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
4 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: ProspectivePopulation: Intent to Treat
Number of patients reporting adverse events
Outcome measures
| Measure |
hCRF
n=112 Participants
hCRF administered 1mg bid subcutaneously
|
|---|---|
|
Long Term Safety and Tolerability of hCRF
|
111 Participants
4.5
|
Adverse Events
hCRF
Serious events: 72 serious events
Other events: 111 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
hCRF
n=112 participants at risk
All patients will receive hCRF (XERECEPT) 2mg/day
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.89%
1/112 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
0.89%
1/112 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.89%
1/112 • Number of events 1
|
|
Eye disorders
Blindness
|
0.89%
1/112 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.89%
1/112 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.89%
1/112 • Number of events 1
|
|
General disorders
Asthenia
|
0.89%
1/112 • Number of events 1
|
|
General disorders
Injection site urticaria
|
1.8%
2/112 • Number of events 2
|
|
General disorders
Pain
|
0.89%
1/112 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.89%
1/112 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.89%
1/112 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
0.89%
1/112 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
3.6%
4/112 • Number of events 4
|
|
Infections and infestations
Clostridial infection
|
0.89%
1/112 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
0.89%
1/112 • Number of events 1
|
|
Infections and infestations
Perianal abscess
|
0.89%
1/112 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
4.5%
5/112 • Number of events 5
|
|
Infections and infestations
Rectal abscess
|
0.89%
1/112 • Number of events 1
|
|
Infections and infestations
Sepsis
|
2.7%
3/112 • Number of events 3
|
|
Infections and infestations
Septic shock
|
1.8%
2/112 • Number of events 2
|
|
Infections and infestations
Tooth infection
|
0.89%
1/112 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.89%
1/112 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.89%
1/112 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
3.6%
4/112 • Number of events 4
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.89%
1/112 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.89%
1/112 • Number of events 1
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.89%
1/112 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.89%
1/112 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.8%
2/112 • Number of events 2
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.89%
1/112 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.89%
1/112 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound
|
0.89%
1/112 • Number of events 1
|
|
Metabolism and nutrition disorders
Gout
|
0.89%
1/112 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.89%
1/112 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.89%
1/112 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma
|
0.89%
1/112 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
1.8%
2/112 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
4.5%
5/112 • Number of events 5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
0.89%
1/112 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.89%
1/112 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.89%
1/112 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.89%
1/112 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrom
|
0.89%
1/112 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
22.3%
25/112 • Number of events 25
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.89%
1/112 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.89%
1/112 • Number of events 1
|
|
Nervous system disorders
Aphasia
|
0.89%
1/112 • Number of events 1
|
|
Nervous system disorders
Brain oedema
|
0.89%
1/112 • Number of events 1
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.89%
1/112 • Number of events 1
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.89%
1/112 • Number of events 1
|
|
Nervous system disorders
Cerebrospinal fistula
|
0.89%
1/112 • Number of events 1
|
|
Nervous system disorders
Convulsion
|
15.2%
17/112 • Number of events 17
|
|
Nervous system disorders
Encephalopathy
|
0.89%
1/112 • Number of events 1
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.8%
2/112 • Number of events 2
|
|
Nervous system disorders
Headache
|
2.7%
3/112 • Number of events 3
|
|
Nervous system disorders
Status epilepticus
|
0.89%
1/112 • Number of events 1
|
|
Nervous system disorders
Syncope
|
1.8%
2/112 • Number of events 2
|
|
Psychiatric disorders
Agitation
|
7.1%
8/112 • Number of events 8
|
|
Psychiatric disorders
Confusional state
|
0.89%
1/112 • Number of events 1
|
|
Psychiatric disorders
Mental state changes
|
1.8%
2/112 • Number of events 2
|
|
Psychiatric disorders
Personality change
|
0.89%
1/112 • Number of events 1
|
|
Psychiatric disorders
Psychotic disorder
|
1.8%
2/112 • Number of events 2
|
|
Renal and urinary disorders
Renal failure acute
|
1.8%
2/112 • Number of events 2
|
|
Renal and urinary disorders
Rena tubular necrosis
|
0.89%
1/112 • Number of events 1
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.89%
1/112 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.89%
1/112 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.89%
1/112 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.89%
1/112 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.89%
1/112 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.8%
2/112 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.89%
1/112 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.89%
1/112 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
4.5%
5/112 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.6%
4/112 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.89%
1/112 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
1.8%
2/112 • Number of events 2
|
|
Vascular disorders
Hypotension
|
0.89%
1/112 • Number of events 1
|
|
Vascular disorders
Venous thrombosis limb
|
0.89%
1/112 • Number of events 1
|
Other adverse events
| Measure |
hCRF
n=112 participants at risk
All patients will receive hCRF (XERECEPT) 2mg/day
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
11.6%
13/112 • Number of events 13
|
|
Gastrointestinal disorders
Nausea
|
20.5%
23/112 • Number of events 23
|
|
General disorders
Injection site erythema
|
16.1%
18/112 • Number of events 18
|
|
General disorders
Oedema peripheral
|
11.6%
13/112 • Number of events 13
|
|
Endocrine disorders
Cushingoid
|
7.1%
8/112 • Number of events 8
|
|
Eye disorders
Vision blurred
|
6.2%
7/112 • Number of events 7
|
|
Gastrointestinal disorders
Constipation
|
9.8%
11/112 • Number of events 11
|
|
Gastrointestinal disorders
Vomiting
|
10.7%
12/112 • Number of events 12
|
|
General disorders
Asthenia
|
6.2%
7/112 • Number of events 7
|
|
General disorders
Fatigue
|
20.5%
23/112 • Number of events 23
|
|
General disorders
Gait disturbance
|
7.1%
8/112 • Number of events 8
|
|
Infections and infestations
Pneumonia
|
8.0%
9/112 • Number of events 9
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
9/112 • Number of events 9
|
|
Infections and infestations
Urinary tract infection
|
7.1%
8/112 • Number of events 8
|
|
Injury, poisoning and procedural complications
Contusion
|
6.2%
7/112 • Number of events 7
|
|
Investigations
Alanine aminotransferase increased
|
5.4%
6/112 • Number of events 6
|
|
Investigations
Weight decreased
|
5.4%
6/112 • Number of events 6
|
|
Metabolism and nutrition disorders
Anorexia
|
5.4%
6/112 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.1%
8/112 • Number of events 8
|
|
Injury, poisoning and procedural complications
Fall
|
10.7%
12/112 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
8/112 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
8/112 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
12.5%
14/112 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.4%
6/112 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
7/112 • Number of events 7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
glioblastoma multiforme
|
7.1%
8/112 • Number of events 8
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
30.4%
34/112 • Number of events 34
|
|
Nervous system disorders
Aphasia
|
8.0%
9/112 • Number of events 9
|
|
Nervous system disorders
Convulsion
|
28.6%
32/112 • Number of events 32
|
|
Nervous system disorders
Dizziness
|
7.1%
8/112 • Number of events 8
|
|
Nervous system disorders
Headache
|
26.8%
30/112 • Number of events 30
|
|
Nervous system disorders
Hemiparesis
|
13.4%
15/112 • Number of events 15
|
|
Nervous system disorders
Hypoaesthesia
|
8.9%
10/112 • Number of events 10
|
|
Nervous system disorders
Tremor
|
6.2%
7/112 • Number of events 7
|
|
Psychiatric disorders
Confusional state
|
9.8%
11/112 • Number of events 11
|
|
Psychiatric disorders
Depression
|
5.4%
6/112 • Number of events 6
|
|
Psychiatric disorders
Insomnia
|
9.8%
11/112 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
8/112 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
8/112 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
8/112 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Skin fragility
|
6.2%
7/112 • Number of events 7
|
|
Vascular disorders
Flushing
|
24.1%
27/112 • Number of events 27
|
Additional Information
Director Medical Sciences
Celtic Pharma Development Services America Inc
Phone: (212) 616 4016
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60