NCT00783393已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Overall response in Step 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 >=
- •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.
排除标准
- •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.
研究组 & 干预措施
Single arm
Experimental
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.
干预措施: Temozolomide (Drug)
结局指标
主要结局
Overall response in Step 1
时间窗: 6 months
Incidence rate and severity of adverse events with administration of temozolomide in Step 1
时间窗: 7 months (during temozolomide administration for 6 months and follow-up for 1 month)
次要结局
- Neurological improvement in Step 1(6 months)
- Progression-free survival, overall survival, overall response, effect on neurological symptoms, and safety in Step 2(6 months)
- Overall response in Step 2(Up to 2 years)
- Overall survival in Step 2(Up to 2 years)
- Effect on neurological symptoms in Step 2(Up to 2 years)
- Progression-free survival in Step 1(6 months)
- Overall survival in Step 1(6 months)
- Tumor response in Step 1(6 months)
- Progression-free survival in Step 2(Up to 2 years)
- Safety in Step 2(Up to 2 years)
研究者
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