SCH 52365 Phase II Clinical Study: A Study on the Efficacy and Safety of Monotherapy With SCH 52365 in Patients With First Relapsed Anaplastic Astrocytoma (Study P03745)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00783393
First received: October 30, 2008
Last updated: May 1, 2014
Last verified: May 2014

October 30, 2008
May 1, 2014
September 2003
June 2005   (final data collection date for primary outcome measure)
  • Overall response in Step 1 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Incidence rate and severity of adverse events with administration of temozolomide in Step 1 [ Time Frame: 7 months (during temozolomide administration for 6 months and follow-up for 1 month) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00783393 on ClinicalTrials.gov Archive Site
  • Progression-free survival in Step 1 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Overall survival in Step 1 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Tumor response in Step 1 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Neurological improvement in Step 1 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Progression-free survival, overall survival, overall response, effect on neurological symptoms, and safety in Step 2 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Progression-free survival in Step 2 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Overall survival in Step 2 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Overall response in Step 2 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Effect on neurological symptoms in Step 2 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Safety in Step 2 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
SCH 52365 Phase II Clinical Study: A Study on the Efficacy and Safety of Monotherapy With SCH 52365 in Patients With First Relapsed Anaplastic Astrocytoma (Study P03745)
SCH 52365 Phase II Clinical Study: A Study on the Efficacy and Safety of Monotherapy With SCH 52365 in Patients With First Relapsed Anaplastic Astrocytoma

The primary purpose of the study is to evaluate the efficacy (overall response) and safety of temozolomide in Step 1 at the dose and regimen approved in the US and the EU countries (28 day cycles of temozolomide at 150 to 200 mg/m2 once daily for 5 consecutive days with a 23 day rest period) in patients with anaplastic astrocytoma at first relapse.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Astrocytoma
Drug: Temozolomide
Temozolomide orally once daily for 5 consecutive days followed by a 23 day rest period to complete a 28 day treatment cycle. In Cycle 1, temozolomide will be administered at 150 mg/m2/day; in Cycle 2 and subsequent cycles, it will be administered at 100, 150, or 200 mg/m2, depending on hematology test results and adverse events observed.
Other Name: Temodal, Temodar, SCH 052365
Experimental: Single arm

The study consists of two steps:

  • Step 1, the therapeutic study phase, comprising six cycles of treatment with temozolomide, and
  • Step 2, the long-term treatment phase, where subjects with at least disease stabilization at the end of Step 1 may continue temozolomide treatment until unacceptable toxicity or disease progression occur, up to a maximum of 2 years from the start of treatment in Cycle 1.
Intervention: Drug: Temozolomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
October 2006
June 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject must have histologically confirmed anaplastic astrocytoma on the tentorium at first relapse, and satisfy the following:

    • unequivocal evidence of tumor recurrence or aggravation by MRI scan after treatment for initial onset; the lesions must be measurable;
    • anaplastic astrocytoma diagnosed histologically by the last pathological diagnostic tests (including initial diagnosis) prior to initial administration of temozolomide;
    • tissue samples available for Central Pathologic Reviewer;
    • pathologic diagnosis report by the study-conducting medical institution must be available for the sponsor.
  • MRI-related criteria:

    • MRI scan performed within 14 days before initial temozolomide administration;
    • assessable tumor site confirmed by MRI;
    • dosage of steroidal agents not increased within 7 days before MRI prior to initial temozolomide administration, except for postoperative subjects for first relapse;
    • MRI performed at the Principal Investigator's study location or designated radiology facility during the study.
  • Age >=18 years, either sex, inpatients or outpatients.
  • Use of medically approved contraception methods in fertile subjects.
  • Karnofsky performance status >=70.
  • Adequate clinically laboratory values obtained within 14 days before initial temozolomide administration.
  • Criteria regarding treatment of initial onset:

    • tumor biopsy, regardless of tumor resection at initial diagnosis;
    • prior radiation therapy;
    • prior chemotherapy with up to one nitrosourea-containing regimen.
  • Tumor may or may not have been surgically resected at first relapse, but residual measurable disease is required.
  • For subjects who had surgical resection of tumor at first relapse:

    • MRI scan must have been performed within 72 hours after surgery.
    • the dose of steroidal agents must be reduced before temozolomide administration.
  • Life expectancy >=12 weeks.
  • Written informed consent obtained.

Exclusion Criteria:

  • History of treatment with dacarbazine.
  • Subjects who received chemotherapy within 6 weeks before initial temozolomide administration.
  • Subjects who received interstitial radiotherapy or stereotactic radiosurgery.
  • Subjects who completed radiotherapy within 12 weeks before initial temozolomide administration.
  • Surgery at first relapse (including biopsy) within 1 week before initial temozolomide administration.
  • Subjects not recovered from acute toxicity due to previous therapy.
  • High-risk subjects with complication of diseases other than malignant tumor, or who require systemic administration of antibiotics for infection.
  • Previous or concurrent malignancies at other sites.
  • Pregnant or nursing women.
  • Women of childbearing potential not using an effective method of contraception.
  • Subjects previously treated with temozolomide.
  • Participation in an ongoing clinical study, or in other clinical studies within 6 months before initial temozolomide administration.
  • Subjects found inappropriate for the study by the investigator or subinvestigator.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00783393
P03745, JPC02-351-21
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP