Trial Outcomes & Findings for The Effects of Continuous 28-day (28/28) Temozolomide Chemotherapy in Subjects With Recurrent Malignant Glioma Who Have Failed the Conventional 5-day (5/28) Treatment (P04601) (NCT NCT00392171)
NCT ID: NCT00392171
Last Updated: 2017-06-07
Results Overview
Progression-free survival as determined by Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
6 months
Results posted on
2017-06-07
Participant Flow
Participant milestones
| Measure |
Temozolomide
Temozolomide will be administered at a dose of 50 mg/m\^2 for cycles of 28 days for 12 months or until progression.
|
|---|---|
|
Overall Study
STARTED
|
120
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
105
|
Reasons for withdrawal
| Measure |
Temozolomide
Temozolomide will be administered at a dose of 50 mg/m\^2 for cycles of 28 days for 12 months or until progression.
|
|---|---|
|
Overall Study
Did not meet inclusion criteria
|
4
|
|
Overall Study
Disease progression
|
101
|
Baseline Characteristics
The Effects of Continuous 28-day (28/28) Temozolomide Chemotherapy in Subjects With Recurrent Malignant Glioma Who Have Failed the Conventional 5-day (5/28) Treatment (P04601)
Baseline characteristics by cohort
| Measure |
Temozolomide
n=120 Participants
Temozolomide will be administered at a dose of 50 mg/m\^2 for cycles of 28 days for 12 months or until progression.
|
|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
120 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Participants who received allocated intervention. The percentage of participants reported is based on the number of participants within each category (not total number of all categories combined).
Progression-free survival as determined by Kaplan-Meier method.
Outcome measures
| Measure |
Temozolomide
n=116 Participants
Temozolomide will be administered at a dose of 50 mg/m\^2 for cycles of 28 days for 12 months or until progression.
|
|---|---|
|
Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression.
Anaplastic Glioma (n=28)
|
35.7 Percentage of Participants
|
|
Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression.
Early Glioblastoma Multiforme (GBM) (n=33)
|
27.3 Percentage of Participants
|
|
Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression.
Extended Glioblastoma Multiforme (GBM) (n=27)
|
7.4 Percentage of Participants
|
|
Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression.
Rechallenge Glioblastoma Multiforme (GBM) (n=28)
|
35.7 Percentage of Participants
|
Adverse Events
Temozolomide
Serious events: 27 serious events
Other events: 111 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Temozolomide
n=120 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.83%
1/120 • Number of events 1
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.83%
1/120 • Number of events 1
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.83%
1/120 • Number of events 1
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.83%
1/120 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA
|
0.83%
1/120 • Number of events 1
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.83%
1/120 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
0.83%
1/120 • Number of events 1
|
|
General disorders
ASTHENIA
|
0.83%
1/120 • Number of events 1
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
1.7%
2/120 • Number of events 2
|
|
General disorders
IRRITABILITY
|
0.83%
1/120 • Number of events 1
|
|
General disorders
PAIN
|
1.7%
2/120 • Number of events 2
|
|
Infections and infestations
HERPES ZOSTER
|
0.83%
1/120 • Number of events 1
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.83%
1/120 • Number of events 2
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.83%
1/120 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.83%
1/120 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.83%
1/120 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM PROGRESSION
|
0.83%
1/120 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR HAEMORRHAGE
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
APHASIA
|
1.7%
2/120 • Number of events 2
|
|
Nervous system disorders
ATAXIA
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
BALANCE DISORDER
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
CONVULSION
|
3.3%
4/120 • Number of events 4
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
DYSARTHRIA
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
GRAND MAL CONVULSION
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
HEADACHE
|
1.7%
2/120 • Number of events 2
|
|
Nervous system disorders
HEMIPARESIS
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
HEMIPLEGIA
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
HYDROCEPHALUS
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
MONOPARESIS
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
POSTICTAL PARALYSIS
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
SOMNOLENCE
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
SPEECH DISORDER
|
0.83%
1/120 • Number of events 1
|
|
Psychiatric disorders
ANXIETY
|
0.83%
1/120 • Number of events 1
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
2.5%
3/120 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.83%
1/120 • Number of events 1
|
Other adverse events
| Measure |
Temozolomide
n=120 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
5.8%
7/120 • Number of events 7
|
|
Eye disorders
VISION BLURRED
|
5.8%
7/120 • Number of events 8
|
|
Gastrointestinal disorders
CONSTIPATION
|
12.5%
15/120 • Number of events 16
|
|
Gastrointestinal disorders
DIARRHOEA
|
6.7%
8/120 • Number of events 9
|
|
Gastrointestinal disorders
DYSPEPSIA
|
5.8%
7/120 • Number of events 7
|
|
Gastrointestinal disorders
NAUSEA
|
29.2%
35/120 • Number of events 40
|
|
Gastrointestinal disorders
VOMITING
|
20.0%
24/120 • Number of events 29
|
|
General disorders
ASTHENIA
|
6.7%
8/120 • Number of events 9
|
|
General disorders
FATIGUE
|
40.0%
48/120 • Number of events 64
|
|
General disorders
GAIT DISTURBANCE
|
10.8%
13/120 • Number of events 18
|
|
General disorders
OEDEMA
|
5.8%
7/120 • Number of events 10
|
|
General disorders
OEDEMA PERIPHERAL
|
7.5%
9/120 • Number of events 10
|
|
Infections and infestations
ORAL CANDIDIASIS
|
8.3%
10/120 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
6.7%
8/120 • Number of events 8
|
|
Nervous system disorders
BALANCE DISORDER
|
7.5%
9/120 • Number of events 11
|
|
Nervous system disorders
CONVULSION
|
13.3%
16/120 • Number of events 22
|
|
Nervous system disorders
DIZZINESS
|
6.7%
8/120 • Number of events 11
|
|
Nervous system disorders
HEADACHE
|
28.3%
34/120 • Number of events 51
|
|
Nervous system disorders
HEMIANOPIA
|
6.7%
8/120 • Number of events 9
|
|
Nervous system disorders
HEMIPARESIS
|
18.3%
22/120 • Number of events 31
|
|
Nervous system disorders
HYPOAESTHESIA
|
5.8%
7/120 • Number of events 8
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
14.2%
17/120 • Number of events 28
|
|
Nervous system disorders
MONOPARESIS
|
9.2%
11/120 • Number of events 19
|
|
Nervous system disorders
SOMNOLENCE
|
8.3%
10/120 • Number of events 12
|
|
Nervous system disorders
SPEECH DISORDER
|
5.8%
7/120 • Number of events 9
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
10.8%
13/120 • Number of events 20
|
|
Psychiatric disorders
INSOMNIA
|
10.8%
13/120 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
11.7%
14/120 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
8.3%
10/120 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
RASH
|
8.3%
10/120 • Number of events 10
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Study Chair agrees not to publish/present any interim results without prior Sponsor written consent. Investigators agree to provide 30 days to review prior to submission. Sponsor shall have proper representation/editorial rights/right to review/comment with regard to proprietary information. If the parties disagree concerning the appropriateness and/or confidentiality of information, Investigators agree to discuss and resolve any such issues prior to submission.
- Publication restrictions are in place
Restriction type: OTHER