NCT00806156已完成2 期
A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of NKTR-102 When Given on a Q14 Day or a Q21 Day Schedule in Patients With Metastatic or Locally Advanced Platinum-Resistant Ovarian Cancer
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
- 178
- 试验地点
- 20
- 主要终点
- Primary: Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST): Primary Efficacy Population
研究概览
简要总结
This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients with metastatic or locally advanced platinum-resistant ovarian cancer.
Approximately 70 patients will be randomized 1:1 into one of two treatment arms. NKTR-102 will be administered at a dose level of 145 mg/m^2 in both arms. In Arm A, NKTR-102 will be given on a q14d schedule. In Arm B, NKTR-102 will be given on a q21d schedule. After the initial 70 patients have been enrolled, Arm B will enroll approximately 110 additional patients.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer
- •Inoperable metastatic or locally advanced ovarian cancer
- •Platinum-resistant ovarian cancer defined as progression by RECIST within 6 months of last dose of most recent platinum drug
- •Platinum-resistant patients who have progressed after receiving PLD (Doxil/Caelyx)therapy in a platinum-resistant setting or who otherwise unable to receive PLD therapy.
- •Diseases must be measurable as defined by RECIST in at least 1 lesion not previously irradiated.
- •ECOG performance score of 0 or
- •Adequate organ and bone marrow functions at Screening.
排除标准
- •Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) and have not recovered to NCI-CTCAE grade 1 toxicity prior to Day 1 of Cycle 1
- •Patients who have had any major surgery within 4 weeks prior to Day 1 of Cycle 1 or minor surgery within 2 weeks prior to Day 1 of Cycle 1
- •Patients who have received CYP3A4 inducers or inhibitors.
- •Patients who have received any treatment with a camptothecin derivative (eg. irinotecan, topotecan, SN38 investigational agents, etc.).
- •Patients with CNS metastases.
研究组 & 干预措施
NKTR-102 q14d
Experimental
NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients.
干预措施: NKTR-102 q14d (Drug)
NKTR-102 q21d
Experimental
NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients.
干预措施: NKTR-102 q21d (Drug)
结局指标
主要结局
Primary: Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST): Primary Efficacy Population
时间窗: Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)
The ORR was defined as the proportion of patients with a complete response (CR) or a partial response (PR) per RECIST 1.0 based upon the best response as assessed by the Investigator. CR was defined by RECIST 1.1 as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \<10 mm. PR was defined by RECIST 1.1 as at least a 30% decrease in the sum of the diameters (SOD) of target lesions, taking as reference the baseline SOD. The analysis was performed for patients in the Primary Efficacy Population.
次要结局
- Secondary: Best Overall Response by Gynecologic Cancer Intergroup (GCIG) Criteria: MITT Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: Best Overall Response by GCIG Criteria: Primary Efficacy Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: Clinical Benefit Rate: Primary Efficacy Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: Clinical Benefit Rate: Platinum-Refractory Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: Clinical Benefit Rate: Prior PLD Therapy Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: Kaplan-Meier Analysis of OS: Platinum-Refractory Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: ORR by RECIST: Prior PLD Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: Best Overall Response by GCIG Criteria: Prior PLD Therapy Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: Best Overall Response by GCIG Criteria: Platinum-Refractory Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: Kaplan-Meier Estimate of Progression-Free Survival (PFS): MITT Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: Kaplan-Meier Estimate of PFS: Primary Efficacy Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: CA-125 Response Rate: Primary Efficacy Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: Kaplan-Meier Estimate of PFS: Platinum-Refractory Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: Kaplan-Meier Estimate of PFS: Prior PLD Therapy Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: Kaplan-Meier Analysis of Duration of Overall Response (DoR): MITT Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: Kaplan-Meier Analysis of DoR: Primary Efficacy Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: Kaplan-Meier Analysis of DoR: Platinum-Refractory Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: Kaplan-Meier Analysis of DoR: Prior PLD Therapy Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: CA-125 Response Rate: MITT Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: CA-125 Response Rate: Platinum-Refractory Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: CA-125 Response Rate: Prior PLD Therapy Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: Clinical Benefit Rate: MITT Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: Kaplan-Meier Analysis of Overall Survival (OS): MITT Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: Kaplan-Meier Analysis of OS: Primary Efficacy Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: ORR by RECIST: MITT Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: ORR by RECIST: Platinum-Refractory Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
- Secondary: Kaplan-Meier Analysis of OS: Prior PLD Therapy Population(Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months))
研究者
研究点 (20)
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