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

This study has been completed.

Study NCT00684567 Information provided by Schering-Plough

First Received: May 22, 2008 Last Updated: September 25, 2009 History of Changes

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

Participant Flow

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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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Measure Type	Primary
Measure Title	Adverse Drug Reactions With an Incidence of Greater Than or Equal to 20%
Measure 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
Safety Issue	Yes

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.
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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.

Measured Values

	Radiotherapy/Temozolomide
Number of Participants Analyzed [units: participants]	30
Adverse Drug Reactions With an Incidence of Greater Than or Equal to 20% [units: Participants]
constipation	15
nausea	11
vomiting	6
neutrophil count decreased	6
weight decreased	6
malaise	7
anorexia	9

No statistical analysis provided for Adverse Drug Reactions With an Incidence of Greater Than or Equal to 20%

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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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