NCT01933061撤回2 期
A Randomized, Open Label, Multi-center Phase 2 Study of Nab-Paclitaxel Versus Epigenetic Modifying Therapy of CC-4386 With Nab-Paclitaxel in Subjects With Chemotherapy naïve Metastatic Melanoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
A phase 2, open-label randomized, multicenter trial to compare CC-486 in combination with Abraxane administered weekly with respect to overall survival, objective tumor response rate and Progression-Free Survival (PFS) in participants diagnosed with metastatic malignant melanoma.
详细描述
The study will consist of the following phases:
- Screening (Baseline) Assessments: Performed within 21 days of randomization.
- Randomization: Subjects will be randomized within 21 days of starting their Baseline assessments.
- Treatment: Therapy may continue in the absence of clinically significant disease progression and unacceptable toxicity.
- Response Assessments: Subjects will be evaluated by investigators for CR, PR, stable or progressive disease every 6 weeks from the start of treatment until progressive disease is documented.
Responders and subjects with stable disease (SD) should continue on study unless they develop unacceptable toxicity, they start a new anticancer therapy, withdrawal of consent, physician decision or death.
- End of Study (EOS)/Treatment Evaluation: At the time subjects are removed from study, laboratory and clinical evaluations will be performed.
- Follow-up for Disease Progression:
- Subjects who stop treatment prior to developing disease progression should be followed without further treatment until progressive disease is documented or until the treating physician feels additional treatment is required.
- Follow-up for Survival:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically or cytologically confirmed cutaneous BRAF wild-type malignant melanoma with evidence of metastasis (Stage IV).
- •No prior cytotoxic chemotherapy for metastatic malignant melanoma is permitted. No prior adjuvant cytotoxic chemotherapy is permitted.
- •Up to one prior regimen with the following classes of agents is permitted:
- •o Targeted biologic agents (e.g. interleukin 2 [IL-2], granulocyte macrophage colony stimulating factor [GM-CSF], other cytokines or unarmed monoclonal antibodies)
- •o Targeted small molecule inhibitors (e.g., kinase inhibitors, heat shock protein [HSP] inhibitors, etc.).
- •Immune checkpoint inhibitors (e.g. anti-CTLA4, anti-PD1, anti-PD-L1).
- •Prior adjuvant therapy with interferon and/or vaccines is permitted.
- •Prior treatments should be completed 4 weeks prior to enrollment in the study (ie, randomization).
- •Male or non-pregnant and non-lactating female, and ≥ 18 years of age at the time of signing the informed consent document.
- •If heterosexually active, the subject must agree to use medical doctor-approved contraception throughout the study, and for 6 months after last dose of study drug.
- •History of malignancy in the last 5 years; subjects with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
- •Subjects with other malignancies are eligible if they were cured by surgery (with or without radiotherapy) and have been continuously disease-free for at least 5 years.
- •Radiographically-documented measurable disease (defined by the presence of at least one radiographically documented measurable lesion including measurable cutaneous metastasis).
- •Adequate haemtological and biochemical parameters:
- •ANC ≥ 1.5 x 109 cells/L.
- •Platelets ≥ 100 x 109 cells/L.
- •Hgb ≥ 9 g/dL.
- •AST (SGOT) or ALT (SGPT) ≥ 2.5x upper limit of normal range (ULN);
- •o ≤ 5.0 x ULN if hepatic metastases present.
- •Total bilirubin ≤ ULN. Creatinine ≤ 1.5 mg/dL.
- •ECOG performance status 0 to 1.
排除标准
- •History of or current evidence of symptomatic brain metastases (brain Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) is needed to exclude brain metastasis), including leptomeningeal involvement.
- •Subject has pre-existing peripheral neuropathy of National Cancer Institute NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Scale of Grade ≥
- •Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
研究组 & 干预措施
Abraxane 150 mg/m² Intravenous (IV)
Experimental
干预措施: Abraxane (Drug)
CC-486 orally plus Abraxane IV
Experimental
干预措施: Abraxane (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Up to 24 months
PFS is defined as the time from randomization date to disease progression according to RECIST response guideline
次要结局
- Disease Control Rate (DCR)(Up to 24 months)
- Safety(Up to 24 months)
- Overall survival (OS)(Up to 24 months)
- PFS(Up to 24 months)
- Objective Response Rate (ORR)(Up to 24 months)
研究者
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