A Phase II Trial of SCH 727965 (NSC 747135) in Patients With Stage IV Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 280
- 主要终点
- Overall Survival
研究概览
简要总结
This phase II trial is studying the side effects and how well dinaciclib works in treating patients with stage IV melanoma. Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
详细描述
PRIMARY OBJECTIVES:
I. To assess the 1-year overall survival rate in patients with stage IV melanoma treated with dinaciclib.
SECONDARY OBJECTIVES:
I. To assess the 6-month progression-free survival rate in these patients. II. To evaluate the response rate (confirmed and unconfirmed complete and partial responses) in the subset of patients with measurable disease.
III. To assess the safety and tolerability of dinaciclib given to patients with stage IV melanoma.
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
- •Biopsy-confirmed malignant melanoma
- •Stage IV disease
- •Cutaneous or mucosal origin
- •Melanoma of unknown primary allowed
- •No ocular melanoma
- •Measurable or non-measurable disease
- •No prior or concurrent brain metastases as confirmed by CT scan or MRI
- •Zubrod performance status 0-1
- •ANC ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9 g/dL
- •Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) (including patients with hepatic metastases)
- •SGOT or SGPT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of hepatic metastases)
- •Serum creatinine ≤ 1.5 times ULN
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
- •No prior therapy with a cyclin-dependent kinase inhibitor
- •At least 14 days since prior radiotherapy
- •At least 28 days since prior systemic chemotherapy
- •At least 28 days since prior adjuvant systemic therapy
- •At least 28 days since prior surgery
- •No more than 1 prior systemic therapy regimen (chemotherapy, biologic/immunotherapy, hormonal therapy, or a combination regimen) for stage IV melanoma and any side effects must have resolved to ≤ grade 1
- •Any number of prior adjuvant systemic therapy regimens allowed, including interferon alfa-2b, GM-CSF, chemotherapy, and chemobiotherapy
- •Therapy for stage IV resected free-of-disease will be considered adjuvant therapy
- •Prior radiotherapy allowed provided any side effects have resolved to ≤ grade 1
- •Prior surgery (for both the primary and stage IV disease) allowed provided side effects have resolved to ≤ grade 1
- •No other concurrent or planned non-study treatment (including chemotherapy, hormonal therapy, biologic therapy, or radiotherapy)
- •No concurrent CYP3A4 inhibitors or inducers
- •No concurrent grapefruit or grapefruit juice
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: Dinaciclib (Drug)
结局指标
主要结局
Overall Survival
时间窗: Weekly, up to 3 years
From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
次要结局
- Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)(Disease assessment was performed every 6 weeks, up to 3 years.)
- Response Rate (Confirmed and Unconfirmed Complete and Partial Responses) Assessed by RECIST(Disease assessments for response were performed every 6 weeks, up to 3 years)
- Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs(Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.)