NCT01006252终止3 期
A Randomized Phase 3 Study of Tasisulam-sodium Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle Versus Paclitaxel as Second-line Treatment in Patients With Metastatic Melanoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The primary purpose of this study was to see how tasisulam-sodium affected metastatic melanoma when compared against paclitaxel as measured by overall 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
- •Have a histologic and/or cytologic diagnosis of metastatic melanoma (Stage IV).
- •Have the presence of evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0).
- •Have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- •Have progressed after 1 previous systemic treatment containing dacarbazine or temozolomide for metastatic melanoma.
- •Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, or other investigational therapy for at least 30 days (6 weeks for mitomycin-C or nitrosoureas) before study enrollment and recovered from the acute effects of therapy (except alopecia).
- •Have a serum albumin level greater than or equal to 3.0 grams per deciliter (g/dL) or greater than or equal to 30 grams per liter (g/L).
排除标准
- •Have received greater than or equal to 2 previous chemotherapy-containing systemic treatment regimens for metastatic melanoma. An immunotherapy or antibody-based regimen (including biologic agents and vaccination-based treatments), or treatment with a targeted agent (for example, BRAF or c-Kit inhibitor is not counted as a prior treatment regimen for determining study eligibility, unless either was combined with a cytotoxic drug).
- •Have active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of study entry. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry to rule out occult brain metastasis. Participants with a history of a solitary CNS metastasis previously treated with curative intent (for example, stereotactic radiation or surgery) and not requiring steroids are eligible.
- •Are receiving warfarin.
- •Have primary ocular or mucosal melanoma.
- •Any previous treatment with paclitaxel or a paclitaxel-containing regimen for metastatic melanoma.
- •Have serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator).
- •Have previously completed or withdrawn from this study or any other study investigating tasisulam-sodium.
- •Have a known hypersensitivity to paclitaxel or Cremophor EL (polyoxyethylated castor oil).
- •Are pregnant or lactating.
- •Have received a recent (within 30 days before enrollment) or are receiving concurrent yellow fever vaccination.
- •Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb).
- •Are unable to withhold dosing of non-steroidal anti-inflammatory drugs (NSAIDs) or proton-pump inhibitors (PPIs) for at least 72 hours before and after treatment with tasisulam-sodium.
研究组 & 干预措施
Tasisulam-sodium
Experimental
Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression.
干预措施: Tasisulam-sodium (Drug)
Paclitaxel
Active Comparator
Paclitaxel 80 milligrams per square meter (mg/m^2) administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Randomization to date of death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 14.32 months
OS is duration from enrollment to death; OS censored for participants who were alive at last contact.
次要结局
- Progression Free Survival (PFS)(Randomization to date of objectively determined PD, or death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 13.70 months)
- Percentage of Randomized Participants Having a Confirmed Best Response of Partial Response (PR) or Complete Response (CR)(First date RECIST criteria met for CR or PR (whichever occurred first) until first date of documented PD, or death from any cause (assessed every other cycle) up to 13.70 months)
- Duration of Response (DoR) for Participants Having an Objective Response of Partial Response (PR) or Complete Response (CR)(First date RECIST criteria met for CR or PR (whichever occurred first) until first date of documented PD, or death from any cause (assessed every other cycle) up to 13.70 months)
- Percentage of Randomized Participants Having a Confirmed Best Overall Response of Partial Response (PR) or Complete Response (CR) Plus Participants With an Overall Response of Stable Disease (SD)(First date RECIST criteria met for CR, PR, or SD until first date of documented progressive disease (PD), or death from any cause (assessed every other cycle) up to 13.70 months)
- Time to Deterioration in the Functional Assessment of Cancer Therapy-Melanoma Trial Outcome Index (FACT-M TOI) Score(Randomization to first date of deterioration in FACT-M TOI, or death from any cause (assessed every cycle and up to 30 days following treatment discontinuation) up to 13.21 months)
- Change From Baseline at Cycle 2 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation(Baseline at Cycle 2, up to 30 days following treatment discontinuation)
- Change From Baseline at Cycle 3 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation(Baseline at Cycle 3, up to 30 days following treatment discontinuation)
- Change From Baseline at Cycle 4 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation(Baseline at Cycle 4, up to 30 days following treatment discontinuation)
- Change From Baseline at Cycle 2 in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation(Baseline at Cycle 2, up to 30 days following treatment discontinuation)
- Change From Baseline at Cycle 3 in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation(Baseline at Cycle 3, up to 30 days following treatment discontinuation)
- Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) During Cycle 1(After drug infusion in Cycle 1 (5 samples drawn over the 28-day cycle))
- Change From Baseline at Cycle 4 Baseline in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation(Baseline at Cycle 4, up to 30 days after treatment discontinuation)
- Pharmacokinetics: Maximum Plasma Concentration (Cmax) During Cycle 2(After drug infusion in Cycle 2 (2 samples drawn over the 28-day cycle))
研究者
研究点 (1)
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