Trial Outcomes & Findings for Temozolomide Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme (Study P04661)(COMPLETED) (NCT NCT00684567)
NCT ID: NCT00684567
Last Updated: 2017-06-07
Results Overview
Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy. Adverse events were classified under the system organ class using MedDRA-J Version 11.0.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
until 30 days after the completion of administration of monotherapy
Results posted on
2017-06-07
Participant Flow
Participant milestones
| Measure |
Radiotherapy/Temozolomide
It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
|
|---|---|
|
Concomitant Radiotherapy Period
STARTED
|
30
|
|
Concomitant Radiotherapy Period
COMPLETED
|
28
|
|
Concomitant Radiotherapy Period
NOT COMPLETED
|
2
|
|
Monotherapy Period
STARTED
|
23
|
|
Monotherapy Period
COMPLETED
|
9
|
|
Monotherapy Period
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Radiotherapy/Temozolomide
It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
|
|---|---|
|
Concomitant Radiotherapy Period
Adverse Event
|
2
|
|
Monotherapy Period
Adverse Event
|
2
|
|
Monotherapy Period
Death
|
1
|
|
Monotherapy Period
Progression of primary disease
|
11
|
Baseline Characteristics
Temozolomide Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme (Study P04661)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Radiotherapy/Temozolomide
n=30 Participants
It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
|
|---|---|
|
Age, Continuous
|
54.2 years
STANDARD_DEVIATION 9.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
|
Centralized Pathologic Diagnosis
High Grade Astrocytoma
|
1 Participants
n=99 Participants
|
|
Centralized Pathologic Diagnosis
Glioblastoma Multiforme
|
27 Participants
n=99 Participants
|
|
Centralized Pathologic Diagnosis
Anaplastic Astrocytoma
|
1 Participants
n=99 Participants
|
|
Centralized Pathologic Diagnosis
Gliosarcoma
|
1 Participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
14 Participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
11 Participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
5 Participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
3
|
0 Participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
4
|
0 Participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
5
|
0 Participants
n=99 Participants
|
|
Type of Surgery
Radical Extraction
|
7 Participants
n=99 Participants
|
|
Type of Surgery
Partial Extraction
|
21 Participants
n=99 Participants
|
|
Type of Surgery
Biopsy
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: until 30 days after the completion of administration of monotherapySafety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy. Adverse events were classified under the system organ class using MedDRA-J Version 11.0.
Outcome measures
| Measure |
Radiotherapy/Temozolomide
n=30 Participants
It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
|
|---|---|
|
Adverse Events With an Incidence of Greater Than or Equal to 20%
pruritus
|
6 Participants
|
|
Adverse Events With an Incidence of Greater Than or Equal to 20%
neutrophil count decreased
|
6 Participants
|
|
Adverse Events With an Incidence of Greater Than or Equal to 20%
alopecia
|
25 Participants
|
|
Adverse Events With an Incidence of Greater Than or Equal to 20%
nausea
|
17 Participants
|
|
Adverse Events With an Incidence of Greater Than or Equal to 20%
anorexia
|
17 Participants
|
|
Adverse Events With an Incidence of Greater Than or Equal to 20%
constipation
|
15 Participants
|
|
Adverse Events With an Incidence of Greater Than or Equal to 20%
malaise
|
14 Participants
|
|
Adverse Events With an Incidence of Greater Than or Equal to 20%
rash
|
11 Participants
|
|
Adverse Events With an Incidence of Greater Than or Equal to 20%
weight decreased
|
11 Participants
|
|
Adverse Events With an Incidence of Greater Than or Equal to 20%
headache
|
10 Participants
|
|
Adverse Events With an Incidence of Greater Than or Equal to 20%
vomiting
|
9 Participants
|
|
Adverse Events With an Incidence of Greater Than or Equal to 20%
dry skin
|
8 Participants
|
|
Adverse Events With an Incidence of Greater Than or Equal to 20%
nasopharyngitis
|
8 Participants
|
|
Adverse Events With an Incidence of Greater Than or Equal to 20%
diarrhea
|
7 Participants
|
|
Adverse Events With an Incidence of Greater Than or Equal to 20%
convulsion
|
7 Participants
|
|
Adverse Events With an Incidence of Greater Than or Equal to 20%
wound complication
|
6 Participants
|
PRIMARY outcome
Timeframe: until 30 days after the completion of administration of monotherapySafety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy.
Outcome measures
| Measure |
Radiotherapy/Temozolomide
n=30 Participants
It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
|
|---|---|
|
Adverse Drug Reactions With an Incidence of Greater Than or Equal to 20%
vomiting
|
6 Participants
|
|
Adverse Drug Reactions With an Incidence of Greater Than or Equal to 20%
neutrophil count decreased
|
6 Participants
|
|
Adverse Drug Reactions With an Incidence of Greater Than or Equal to 20%
constipation
|
15 Participants
|
|
Adverse Drug Reactions With an Incidence of Greater Than or Equal to 20%
nausea
|
11 Participants
|
|
Adverse Drug Reactions With an Incidence of Greater Than or Equal to 20%
weight decreased
|
6 Participants
|
|
Adverse Drug Reactions With an Incidence of Greater Than or Equal to 20%
malaise
|
7 Participants
|
|
Adverse Drug Reactions With an Incidence of Greater Than or Equal to 20%
anorexia
|
9 Participants
|
PRIMARY outcome
Timeframe: until 30 days after the completion of administration of monotherapySafety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy.
Outcome measures
| Measure |
Radiotherapy/Temozolomide
n=30 Participants
It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
|
|---|---|
|
Abnormal Changes in Laboratory Test Values With an Incidence of Greater Than or Equal to 20%
lymphocyte count decreased
|
24 Participants
|
|
Abnormal Changes in Laboratory Test Values With an Incidence of Greater Than or Equal to 20%
white blood cell count decreased
|
14 Participants
|
|
Abnormal Changes in Laboratory Test Values With an Incidence of Greater Than or Equal to 20%
eosinophil percentage increased
|
10 Participants
|
SECONDARY outcome
Timeframe: 1 year after the start of admininstration in the concomitant radiotherapy phaseAdministration of SCH 52365 was continued until progression was observed (progression was judged by the investigator based on MRI and clinical symptoms).
Outcome measures
| Measure |
Radiotherapy/Temozolomide
n=30 Participants
It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
|
|---|---|
|
Number of Participants With Progression Free Survival (PFS) for 1 Year
|
11 Participants
Interval 20.1 to 53.4
|
SECONDARY outcome
Timeframe: 1 year after the start of administration in the concomitant radiotherapy phasePopulation: Response rate in terms of tumor response (ratio of CR + PR) in 19 participants was assessed by Efficacy and Safety Evaluation Committee. 19 participants were found to have measurable lesions. Nineteen participants (as opposed to 30 participants) were analyzed because that is how many participants were still alive 1 year after start of therapy.
CR = measurable lesion disappeared. PR = total sum of lesions measurable in bidimension decreased by 50% or more on whole and no secondary progression attributable to tumor was noted. No onset of new lesion.
Outcome measures
| Measure |
Radiotherapy/Temozolomide
n=19 Participants
It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
|
|---|---|
|
Number of Participants With a Response (Complete Response [CR] + Partial Response [PR]) in Terms of Overall Tumor Response
|
6 Participants
Interval 12.6 to 56.6
|
Adverse Events
Radiotherapy/Temozolomide
Serious events: 13 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Radiotherapy/Temozolomide
n=30 participants at risk
|
|---|---|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
3.3%
1/30 • Number of events 1
|
|
General disorders
NECROSIS
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
PNEUMONIA
|
3.3%
1/30 • Number of events 1
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
3.3%
1/30 • Number of events 1
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
3.3%
1/30 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER
|
3.3%
1/30 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASIS
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
ALTERED STATE OF CONSCIOUSNESS
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
CONVULSION
|
6.7%
2/30 • Number of events 2
|
|
Nervous system disorders
EPILEPSY
|
6.7%
2/30 • Number of events 3
|
|
Nervous system disorders
HYDROCEPHALUS
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
INTRACRANIAL PRESSURE INCREASED
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
PARALYSIS
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
TONIC CONVULSION
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
3.3%
1/30 • Number of events 1
|
Other adverse events
| Measure |
Radiotherapy/Temozolomide
n=30 participants at risk
|
|---|---|
|
Ear and labyrinth disorders
EAR DISCOMFORT
|
10.0%
3/30 • Number of events 3
|
|
Eye disorders
EYE PAIN
|
6.7%
2/30 • Number of events 2
|
|
Eye disorders
VISUAL DISTURBANCE
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
CONSTIPATION
|
50.0%
15/30 • Number of events 19
|
|
Gastrointestinal disorders
DIARRHOEA
|
23.3%
7/30 • Number of events 12
|
|
Gastrointestinal disorders
GASTRITIS
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
NAUSEA
|
56.7%
17/30 • Number of events 21
|
|
Gastrointestinal disorders
STOMACH DISCOMFORT
|
16.7%
5/30 • Number of events 7
|
|
Gastrointestinal disorders
STOMATITIS
|
6.7%
2/30 • Number of events 3
|
|
Gastrointestinal disorders
VOMITING
|
30.0%
9/30 • Number of events 17
|
|
General disorders
FATIGUE
|
6.7%
2/30 • Number of events 3
|
|
General disorders
INFLAMMATION OF WOUND
|
10.0%
3/30 • Number of events 3
|
|
General disorders
MALAISE
|
46.7%
14/30 • Number of events 23
|
|
General disorders
PYREXIA
|
16.7%
5/30 • Number of events 7
|
|
Infections and infestations
NASOPHARYNGITIS
|
26.7%
8/30 • Number of events 9
|
|
Infections and infestations
OTITIS EXTERNA
|
13.3%
4/30 • Number of events 4
|
|
Injury, poisoning and procedural complications
RADIATION SKIN INJURY
|
16.7%
5/30 • Number of events 5
|
|
Injury, poisoning and procedural complications
SUTURE RELATED COMPLICATION
|
6.7%
2/30 • Number of events 2
|
|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
20.0%
6/30 • Number of events 7
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
13.3%
4/30 • Number of events 6
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
6.7%
2/30 • Number of events 3
|
|
Investigations
BASOPHIL PERCENTAGE INCREASED
|
6.7%
2/30 • Number of events 2
|
|
Investigations
BLOOD ALBUMIN DECREASED
|
10.0%
3/30 • Number of events 3
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
16.7%
5/30 • Number of events 7
|
|
Investigations
BLOOD CHLORIDE DECREASED
|
6.7%
2/30 • Number of events 2
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
13.3%
4/30 • Number of events 4
|
|
Investigations
BLOOD PRESSURE SYSTOLIC INCREASED
|
10.0%
3/30 • Number of events 4
|
|
Investigations
BLOOD UREA INCREASED
|
13.3%
4/30 • Number of events 5
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
6.7%
2/30 • Number of events 2
|
|
Investigations
EOSINOPHIL PERCENTAGE INCREASED
|
33.3%
10/30 • Number of events 16
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
6.7%
2/30 • Number of events 2
|
|
Investigations
HAEMOGLOBIN DECREASED
|
6.7%
2/30 • Number of events 2
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
83.3%
25/30 • Number of events 43
|
|
Investigations
MONOCYTE PERCENTAGE INCREASED
|
6.7%
2/30 • Number of events 7
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
23.3%
7/30 • Number of events 12
|
|
Investigations
PLATELET COUNT DECREASED
|
13.3%
4/30 • Number of events 4
|
|
Investigations
PROTEIN TOTAL DECREASED
|
13.3%
4/30 • Number of events 4
|
|
Investigations
WEIGHT DECREASED
|
36.7%
11/30 • Number of events 15
|
|
Investigations
WEIGHT INCREASED
|
13.3%
4/30 • Number of events 4
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
46.7%
14/30 • Number of events 28
|
|
Metabolism and nutrition disorders
ANOREXIA
|
56.7%
17/30 • Number of events 28
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
6.7%
2/30 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
6.7%
2/30 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
6.7%
2/30 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
6.7%
2/30 • Number of events 2
|
|
Nervous system disorders
CONVULSION
|
20.0%
6/30 • Number of events 11
|
|
Nervous system disorders
DIZZINESS
|
10.0%
3/30 • Number of events 3
|
|
Nervous system disorders
DYSKINESIA
|
6.7%
2/30 • Number of events 2
|
|
Nervous system disorders
HEADACHE
|
33.3%
10/30 • Number of events 18
|
|
Nervous system disorders
HEMIPLEGIA
|
10.0%
3/30 • Number of events 3
|
|
Nervous system disorders
HYPOAESTHESIA
|
10.0%
3/30 • Number of events 4
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
6.7%
2/30 • Number of events 2
|
|
Nervous system disorders
SENSORY DISTURBANCE
|
10.0%
3/30 • Number of events 3
|
|
Nervous system disorders
SOMNOLENCE
|
6.7%
2/30 • Number of events 2
|
|
Nervous system disorders
TREMOR
|
10.0%
3/30 • Number of events 3
|
|
Psychiatric disorders
INSOMNIA
|
13.3%
4/30 • Number of events 6
|
|
Reproductive system and breast disorders
MENSTRUAL DISORDER
|
6.7%
2/30 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
10.0%
3/30 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
6.7%
2/30 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
13.3%
4/30 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY TRACT INFLAMMATION
|
13.3%
4/30 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
83.3%
25/30 • Number of events 25
|
|
Skin and subcutaneous tissue disorders
DRUG ERUPTION
|
13.3%
4/30 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
26.7%
8/30 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
16.7%
5/30 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
PIGMENTATION DISORDER
|
6.7%
2/30 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
20.0%
6/30 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
RASH
|
36.7%
11/30 • Number of events 18
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place