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Temozolomide Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme (Study P04661)(COMPLETED)

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: NCT00684567
Recruitment Status : Completed
First Posted : May 26, 2008
Results First Posted : March 12, 2009
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Glioblastoma
Interventions Radiation: Radiotherapy
Drug: Temozolomide
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Radiotherapy/Temozolomide
Hide Arm/Group Description It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
Period Title: Concomitant Radiotherapy Period
Started 30
Completed 28
Not Completed 2
Reason Not Completed
Adverse Event             2
Period Title: Monotherapy Period
Started 23 [1]
Completed 9
Not Completed 14
Reason Not Completed
Adverse Event             2
Death             1
Progression of primary disease             11
[1]
5 subjects completed radiotherapy combined therapy phase but did not proceed to monotherapy phase.
Arm/Group Title Radiotherapy/Temozolomide
Hide Arm/Group Description It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
54.2  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
16
  53.3%
Male
14
  46.7%
Centralized Pathologic Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
High Grade Astrocytoma 1
Glioblastoma Multiforme 27
Anaplastic Astrocytoma 1
Gliosarcoma 1
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
0 14
1 11
2 5
3 0
4 0
5 0
[1]
Measure Description: 6-point, ordinal scale specifying patient's ability to perform activities from 0 (fully active) to 5 (dead).
Type of Surgery  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
Radical Extraction 7
Partial Extraction 21
Biopsy 2
1.Primary Outcome
Title Adverse Events With an Incidence of Greater Than or Equal to 20%
Hide Description 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.
Time Frame until 30 days after the completion of administration of monotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiotherapy/Temozolomide
Hide Arm/Group Description:
It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Participants
alopecia 25
nausea 17
anorexia 17
constipation 15
malaise 14
rash 11
weight decreased 11
headache 10
vomiting 9
dry skin 8
nasopharyngitis 8
diarrhea 7
convulsion 7
pruritus 6
neutrophil count decreased 6
wound complication 6
2.Primary Outcome
Title Adverse Drug Reactions With an Incidence of Greater Than or Equal to 20%
Hide Description Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy.
Time Frame until 30 days after the completion of administration of monotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiotherapy/Temozolomide
Hide Arm/Group Description:
It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Participants
constipation 15
nausea 11
vomiting 6
neutrophil count decreased 6
weight decreased 6
malaise 7
anorexia 9
3.Primary Outcome
Title Abnormal Changes in Laboratory Test Values With an Incidence of Greater Than or Equal to 20%
Hide Description Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy.
Time Frame until 30 days after the completion of administration of monotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiotherapy/Temozolomide
Hide Arm/Group Description:
It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Participants
lymphocyte count decreased 24
white blood cell count decreased 14
eosinophil percentage increased 10
4.Secondary Outcome
Title Number of Participants With Progression Free Survival (PFS) for 1 Year
Hide Description Administration of SCH 52365 was continued until progression was observed (progression was judged by the investigator based on MRI and clinical symptoms).
Time Frame 1 year after the start of admininstration in the concomitant radiotherapy phase
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiotherapy/Temozolomide
Hide Arm/Group Description:
It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Participants
11
5.Secondary Outcome
Title Number of Participants With a Response (Complete Response [CR] + Partial Response [PR]) in Terms of Overall Tumor Response
Hide Description

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.

Time Frame 1 year after the start of administration in the concomitant radiotherapy phase
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Radiotherapy/Temozolomide
Hide Arm/Group Description:
It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Participants
6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Radiotherapy/Temozolomide
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Radiotherapy/Temozolomide
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Radiotherapy/Temozolomide
Affected / at Risk (%) # Events
Total   13/30 (43.33%)    
Cardiac disorders   
CARDIO-RESPIRATORY ARREST  1  1/30 (3.33%)  1
General disorders   
NECROSIS  1  1/30 (3.33%)  1
Infections and infestations   
PNEUMONIA  1  1/30 (3.33%)  1
Investigations   
LYMPHOCYTE COUNT DECREASED  1  1/30 (3.33%)  1
NEUTROPHIL COUNT DECREASED  1  1/30 (3.33%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
GASTRIC CANCER  1  1/30 (3.33%)  1
METASTASIS  1  1/30 (3.33%)  1
Nervous system disorders   
ALTERED STATE OF CONSCIOUSNESS  1  1/30 (3.33%)  1
CONVULSION  1  2/30 (6.67%)  2
EPILEPSY  1  2/30 (6.67%)  3
HYDROCEPHALUS  1  1/30 (3.33%)  1
INTRACRANIAL PRESSURE INCREASED  1  1/30 (3.33%)  1
PARALYSIS  1  1/30 (3.33%)  1
TONIC CONVULSION  1  1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders   
COUGH  1  1/30 (3.33%)  1
INTERSTITIAL LUNG DISEASE  1  1/30 (3.33%)  1
PULMONARY EMBOLISM  1  1/30 (3.33%)  1
RESPIRATORY FAILURE  1  1/30 (3.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Radiotherapy/Temozolomide
Affected / at Risk (%) # Events
Total   30/30 (100.00%)    
Ear and labyrinth disorders   
EAR DISCOMFORT  1  3/30 (10.00%)  3
Eye disorders   
EYE PAIN  1  2/30 (6.67%)  2
VISUAL DISTURBANCE  1  2/30 (6.67%)  2
Gastrointestinal disorders   
ABDOMINAL DISTENSION  1  3/30 (10.00%)  3
ABDOMINAL PAIN  1  2/30 (6.67%)  2
CONSTIPATION  1  15/30 (50.00%)  19
DIARRHOEA  1  7/30 (23.33%)  12
GASTRITIS  1  3/30 (10.00%)  3
HAEMORRHOIDS  1  3/30 (10.00%)  3
NAUSEA  1  17/30 (56.67%)  21
STOMACH DISCOMFORT  1  5/30 (16.67%)  7
STOMATITIS  1  2/30 (6.67%)  3
VOMITING  1  9/30 (30.00%)  17
General disorders   
FATIGUE  1  2/30 (6.67%)  3
INFLAMMATION OF WOUND  1  3/30 (10.00%)  3
MALAISE  1  14/30 (46.67%)  23
PYREXIA  1  5/30 (16.67%)  7
Infections and infestations   
NASOPHARYNGITIS  1  8/30 (26.67%)  9
OTITIS EXTERNA  1  4/30 (13.33%)  4
Injury, poisoning and procedural complications   
RADIATION SKIN INJURY  1  5/30 (16.67%)  5
SUTURE RELATED COMPLICATION  1  2/30 (6.67%)  2
WOUND COMPLICATION  1  6/30 (20.00%)  7
Investigations   
ALANINE AMINOTRANSFERASE INCREASED  1  4/30 (13.33%)  6
ASPARTATE AMINOTRANSFERASE INCREASED  1  2/30 (6.67%)  3
BASOPHIL PERCENTAGE INCREASED  1  2/30 (6.67%)  2
BLOOD ALBUMIN DECREASED  1  3/30 (10.00%)  3
BLOOD ALKALINE PHOSPHATASE INCREASED  1  5/30 (16.67%)  7
BLOOD CHLORIDE DECREASED  1  2/30 (6.67%)  2
BLOOD LACTATE DEHYDROGENASE INCREASED  1  4/30 (13.33%)  4
BLOOD PRESSURE SYSTOLIC INCREASED  1  3/30 (10.00%)  4
BLOOD UREA INCREASED  1  4/30 (13.33%)  5
C-REACTIVE PROTEIN INCREASED  1  2/30 (6.67%)  2
EOSINOPHIL PERCENTAGE INCREASED  1  10/30 (33.33%)  16
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  2/30 (6.67%)  2
HAEMOGLOBIN DECREASED  1  2/30 (6.67%)  2
LYMPHOCYTE COUNT DECREASED  1  25/30 (83.33%)  43
MONOCYTE PERCENTAGE INCREASED  1  2/30 (6.67%)  7
NEUTROPHIL COUNT DECREASED  1  7/30 (23.33%)  12
PLATELET COUNT DECREASED  1  4/30 (13.33%)  4
PROTEIN TOTAL DECREASED  1  4/30 (13.33%)  4
WEIGHT DECREASED  1  11/30 (36.67%)  15
WEIGHT INCREASED  1  4/30 (13.33%)  4
WHITE BLOOD CELL COUNT DECREASED  1  14/30 (46.67%)  28
Metabolism and nutrition disorders   
ANOREXIA  1  17/30 (56.67%)  28
Musculoskeletal and connective tissue disorders   
BACK PAIN  1  2/30 (6.67%)  2
MUSCULOSKELETAL STIFFNESS  1  2/30 (6.67%)  2
NECK PAIN  1  2/30 (6.67%)  2
PAIN IN EXTREMITY  1  2/30 (6.67%)  2
Nervous system disorders   
CONVULSION  1  6/30 (20.00%)  11
DIZZINESS  1  3/30 (10.00%)  3
DYSKINESIA  1  2/30 (6.67%)  2
HEADACHE  1  10/30 (33.33%)  18
HEMIPLEGIA  1  3/30 (10.00%)  3
HYPOAESTHESIA  1  3/30 (10.00%)  4
MEMORY IMPAIRMENT  1  2/30 (6.67%)  2
SENSORY DISTURBANCE  1  3/30 (10.00%)  3
SOMNOLENCE  1  2/30 (6.67%)  2
TREMOR  1  3/30 (10.00%)  3
Psychiatric disorders   
INSOMNIA  1  4/30 (13.33%)  6
Reproductive system and breast disorders   
MENSTRUAL DISORDER  1  2/30 (6.67%)  2
Respiratory, thoracic and mediastinal disorders   
COUGH  1  3/30 (10.00%)  3
DYSPNOEA  1  2/30 (6.67%)  2
PHARYNGOLARYNGEAL PAIN  1  4/30 (13.33%)  4
UPPER RESPIRATORY TRACT INFLAMMATION  1  4/30 (13.33%)  4
Skin and subcutaneous tissue disorders   
ALOPECIA  1  25/30 (83.33%)  25
DRUG ERUPTION  1  4/30 (13.33%)  4
DRY SKIN  1  8/30 (26.67%)  10
ERYTHEMA  1  5/30 (16.67%)  7
PIGMENTATION DISORDER  1  2/30 (6.67%)  2
PRURITUS  1  6/30 (20.00%)  7
RASH  1  11/30 (36.67%)  18
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00684567    
Other Study ID Numbers: P04661
JPC-05-351-22
First Submitted: May 22, 2008
First Posted: May 26, 2008
Results First Submitted: October 31, 2008
Results First Posted: March 12, 2009
Last Update Posted: June 7, 2017