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SCH 52365 Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme


Phase 2
18 Years
70 Years
Not Enrolling
Both
Glioblastoma

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Trial Information

SCH 52365 Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme


Inclusion Criteria:



- Histopathologically confirmed newly diagnosed glioblastoma multiforme with WHO grade
IV.

- Histological diagnosis must be made locally after biopsy or neurosurgical tumor
resection.

- Four or more unstained tissue sections or a paraffin block must be provided to the
Pathological Judgment Committee as tissue specimens.

- Initial surgery/biopsy at diagnosis performed <=6 weeks (42 days) prior to treatment
with temozolomide.

- Age: >=18 and <=70 years.

- ECOG performance status <=2.

- Stable, non-increasing dose of corticosteroids over the 14 days prior to treatment
with temozolomide.

- No prior chemotherapy or radiotherapy.

- Laboratory test values obtained within 14 days before initiation of administration of
temozolomide must satisfy the following criteria:

- absolute neutrophil count >= 1500/mm^3;

- platelet count >= 100,000/mm^3;

- serum creatinine <=1.5 times the upper limit of laboratory normal;

- total bilirubin <=1.5 times the upper limit of laboratory normal;

- glutamic oxaloacetic transaminase or glutamic pyruvic transaminase <2.5 times
the upper limit of laboratory normal;

- alkaline phosphatase < 2.5 times the upper limit of laboratory normal.

- Absence of pathological conditions that interfere with taking oral drugs.

- Contraception during the study period (from informed consent to the day of the last
observation/examination of this study) is required in sexually active, potentially
fertile patients, regardless of sex, under the supervision of the investigator or
sub-investigator.

- The investigator and/or subinvestigator must judge that life expectancy is 12 weeks
or more.

- Patients may be included regardless of sex or inpatient/outpatient.

Exclusion Criteria:

- Extensively disseminated glioblastoma multiforme.

- Severe disorders in the heart, liver, kidney, blood, etc.

- Presence of previous or concurrent malignancies at other sites with the exception of
surgically cured carcinoma in-situ of the cervix and non melanoma skin cancer.

- Women who are pregnant or lactating.

- Women who may be pregnant or who could become pregnant and do not adopt contraception
method(s).

- Participation in another clinical study within 6 weeks prior to the initiation of
administration of temozolomide.

- Subjects who the investigator and/or subinvestigator judged inappropriate to
participate in the study.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse Events With an Incidence of Greater Than or Equal to 20%

Outcome 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.

Outcome Time Frame:

until 30 days after the completion of administration of monotherapy

Safety Issue:

Yes

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

P04661

NCT ID:

NCT00684567

Start Date:

September 2005

Completion Date:

October 2007

Related Keywords:

  • Glioblastoma
  • Glioblastoma

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