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

Study Type:	Interventional
Study Design:	Open Label, Uncontrolled, Single Group Assignment
Condition:	Glioblastoma
Interventions:	Radiation: Radiotherapy Drug: Temozolomide

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Radiotherapy/Temozolomide	It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.

Participant Flow for 2 periods

Period: Concomitant Radiotherapy Period

	Radiotherapy/Temozolomide
STARTED	30
COMPLETED	28
NOT COMPLETED	2
Adverse Event	2

Period: Monotherapy Period

	Radiotherapy/Temozolomide
STARTED	23^[1]
COMPLETED	9
NOT COMPLETED	14
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.

Baseline Characteristics

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Reporting Groups

	Description
Radiotherapy/Temozolomide	It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.

Baseline Measures

	Radiotherapy/Temozolomide
Number of Participants [units: participants]	30
Age [units: years] Mean ± Standard Deviation	54.2 ± 9.4
Gender [units: Participants]
Female	16
Male	14
Centralized Pathologic Diagnosis [units: Participants]
High Grade Astrocytoma	1
Glioblastoma Multiforme	27
Anaplastic Astrocytoma	1
Gliosarcoma	1
Eastern Cooperative Oncology Group (ECOG) Performance Status^[1] [units: Participants]
0	14
1	11
2	5
3	0
4	0
5	0
Type of Surgery [units: Participants]
Radical Extraction	7
Partial Extraction	21
Biopsy	2

[1]	6-point, ordinal scale specifying patient's ability to perform activities from 0 (fully active) to 5 (dead).

Outcome Measures

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1. Primary:

Adverse Events With an Incidence of Greater Than or Equal to 20% [ until 30 days after the completion of administration of monotherapy ]

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2. Primary:

Adverse Drug Reactions With an Incidence of Greater Than or Equal to 20% [ until 30 days after the completion of administration of monotherapy ]

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3. Primary:

Abnormal Changes in Laboratory Test Values With an Incidence of Greater Than or Equal to 20% [ until 30 days after the completion of administration of monotherapy ]

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4. Secondary:

Number of Participants With Progression Free Survival (PFS) for 1 Year [ 1 year after the start of admininstration in the concomitant radiotherapy phase ]

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5. Secondary:

Number of Participants With a Response (Complete Response [CR] + Partial Response [PR]) in Terms of Overall Tumor Response [ 1 year after the start of administration in the concomitant radiotherapy phase ]

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Measure Type	Secondary
Measure Title	Number of Participants With a Response (Complete Response [CR] + Partial Response [PR]) in Terms of Overall Tumor Response
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Radiotherapy/Temozolomide	It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.

Measured Values

	Radiotherapy/Temozolomide
Number of Participants Analyzed [units: participants]	19
Number of Participants With a Response (Complete Response [CR] + Partial Response [PR]) in Terms of Overall Tumor Response [units: Participants]	6

No statistical analysis provided for Number of Participants With a Response (Complete Response [CR] + Partial Response [PR]) in Terms of Overall Tumor Response

Serious Adverse Events

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Other Adverse Events

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More Information

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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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04661, JPC-05-351-22
Study First Received:	May 22, 2008
Results First Received:	October 31, 2008
Last Updated:	September 25, 2009
ClinicalTrials.gov Identifier:	NCT00684567 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency