A Phase II, Multi-center, Open-label, Uncontrolled Study to Evaluate the Efficacy and Safety of BAY 43-9006 Given Daily in Combination With Repeated 21-Day Cycles of Dacarbazine (DTIC) Chemotherapy in Subjects With Advanced Metastatic Melanoma.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 83
- 主要终点
- Overall Best Response
研究概览
简要总结
The purpose of this study is to see whether a new type of anti-cancer drug, known as BAY 43-9006, can be given safely and with good effect in combination with dacarbazine (DTIC). DTIC is the current standard chemotherapy drug given for melanoma that has spread through the body. Although this drug can be effective on its own and is generally well tolerated, not all patients will benefit, so there is a need to test new drugs and drug combinations for treating melanoma.
详细描述
Issues on "Safety" outcomes are addressed in the Adverse Event section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Subjects with advanced, metastatic, histologically confirmed melanoma, for whom treatment with dacarbazine is considered medically acceptable
- •Age >= 18 years
- •Subject has measurable and evaluable disease defined as at least one metastatic lesion that can be accurately and serially measured by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan as per the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Cutaneous lesions measuring at least 20mm in longest diameter can be considered measurable (and therefore target lesions) via color photography including a ruler
- •Subject has biopsiable disease at baseline and is willing to provide biopsy samples, or does not have biopsiable disease at baseline
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
排除标准
- •Primary ocular or mucosal melanoma (cutaneous vulval melanoma is permitted)
- •Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry
- •(Active coronary artery disease or ischemia (myocardial infarction more than 6 months prior to study entry is allowed)
- •Uncontrolled hypertension (> grade 2 National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0)
- •Active, clinically serious infections (> grade 2 NCI-CTCAE version 3.0)
- •Subjects with seizure disorder requiring medication are excluded
- •History of or suspected Human Immunodeficiency Virus (HIV) infection, or chronic hepatitis B or C
- •Symptomatic metastatic brain or meningeal tumors unless the subject is > 6 months from definitive therapy, has a negative imaging study within 4 weeks prior to study entry and is clinically stable with respect to the tumor at the time of study entry. Also the subject must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies)
- •Pregnant or breast-feeding subjects
研究组 & 干预措施
Sorafenib + Dacarbazine
Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral sorafenib (Nexavar, BAY 43-9006), 400 mg twice a day (bid)
干预措施: Sorafenib (Nexavar, BAY43-9006) + Dacarbazine (DTIC) (Drug)
结局指标
主要结局
Overall Best Response
时间窗: during or within 30 days after active therapy
Best Overall Response (BOR): Best tumor response achieved during or within 30 days after active therapy confirmed according to the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR): The disappearance of all target and non-target lesions. Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD was defined as steady state of disease, PD was defined as an increase of at least 20% increase in the sum of the LD of target lesions or appearance of new lesions.
次要结局
- Overall Survival(from start of treatment until death (median 259 days))
- Disease Control (DC)(after start of treatment, at 6 months and 12 months)
- Progression-free Survival(from start of treatment until progression or death before progression (median 259 days))
- Percentage of Subjects With Progression-free Survival at Specific Time-points(from start of treatment until progression or death before progression after 3, 6 and 12 months)
- Duration of Response(from confirmed Complete Response (CR) or Partial Response (PR) until Progressive Disease (PD) (median 259 days))
- Duration of Complete Response(from confirmed CR until PD (median 259 days))
- Duration of Partial Response(from confirmed PR until PD (median 259 days))
- Time to Response(start of therapy to confirmed CR or PR (median 259 days))
- Time to Progression(From start of treatment until progression (median 259 days))
- Duration of Stable Disease(from start of therapy to PD, only in non-responders (median 259 days))