A Randomised, Double-Blind, Placebo-Controlled Proof Of Concept Study Of Maintenance Therapy With Tasquinimod In Patients With Metastatic Castrate-Resistant Prostate Cancer Who Are Not Progressing After A First Line Docetaxel Based Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Ipsen
- 入组人数
- 144
- 试验地点
- 16
- 主要终点
- Time to Radiological Progression Free Survival [PFS]
研究概览
简要总结
The purpose of this study is to confirm that tasquinimod used as maintenance therapy is active and tolerable in patients with metastatic castrate-resistant prostate cancer not progressing after a first chemotherapy with docetaxel.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically documented prostate cancer with evidence of metastatic disease on radiological evaluation, with or without symptoms (defined according to the BPI scale, with use of analgesics or narcotics)
- •Has received a first line docetaxel based chemotherapy (as a monotherapy) every 3 weeks schedule of administration with corticosteroids for a minimum of 6 cycles with a cumulative dose ≥360 mg/m
- •Any combination with investigational or non investigational agent is prohibited
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Docetaxel-related adverse effects must have been resolved to NCI-CTCAE v4.03 (Common Toxicity Criteria for Adverse Effects) Grade ≤
- •Chemotherapy-induced alopecia and Grade 2 peripheral neuropathy are allowed
- •No progressive disease at the end of docetaxel treatment defined according to RECIST criteria, no new lesion(s) assessed by bone scan and no elevated prostate specific antigen (PSA) for the three last tests with PSA3≤PSA2≤PSA
- •The time between each PSA test should be preferably at least 14 days, however, a minimum of 7 days is acceptable.
- •Note: PSA value can be rounded to the nearest whole number if PSA>10 ng/mL. If the PSA3 value is above the PSA2, a fourth PSA test will be performed. The PSA4 value should be below or equal to PSA2
- •Last dose of docetaxel administered between 21 and 42 days before randomisation
- •Chemical or surgical castration verified by levels of serum testosterone ≤50 ng/dL (1.75 nmol/L)
排除标准
- •Has concurrent use of other anticancer agents or treatments, with the following exceptions: ongoing treatment with luteinising hormone-releasing hormone agonists or antagonists, denosumab or bisphosphonate (e.g., zoledronic acid) is permitted if started ≥4 weeks prior to Screening. Ongoing treatment should be kept at a stable dose regimen
- •Has ongoing treatment with warfarin
- •Had prior radiation therapy since starting docetaxel. Exceptions may be made for palliative non-myelosuppressive radiation therapy administered more than 2 weeks prior to randomisation
- •Had prior strontium, samarium or radium therapy or prior treatment with tasquinimod, or any agents with antiangiogenic properties
- •Has ongoing treatment with corticosteroids at >10 mg/day prednisolone equivalent
- •Has prostate cancer pain that warrants the initiation of radiotherapy or chemotherapy
- •Has known brain or epidural metastases. Patients with previous medullary cord compression without any neurological deficit could be included
- •Has a history of other malignancies, except adequately treated non-melanoma skin cancer or other solid tumours curatively treated, without evidence of disease for >5 years
研究组 & 干预措施
Tasquinimod
1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg or 1 mg per day) until disease progression or toxicity or patient's willingness to stop.
干预措施: Tasquinimod (Drug)
Placebo
1 capsule daily, taken orally with water and food until disease progression or toxicity or patient's willingness to stop.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Radiological Progression Free Survival [PFS]
时间窗: Every 8 weeks until disease progression documentation (approximately up to 2.5 years)
The time from the date of randomisation to the date of radiological progression or death due to any cause. Radiological progression was defined - Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for soft tissue lesions (Eisenhauer, EJC 2009), as at least a 20% relative and a 5 mm absolute increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters recorded on study (including Screening or the appearance of one or more new lesions) for target Lesions. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions - Using Prostate Cancer Clinical Working Group in March 2008 (PCWG2) criteria for bone lesions (Scher, JCO 2008). Progression was defined as appearance of 2 or more bone lesions.
次要结局
- Overall Survival Based on Number of Subjects Who Died(Every 3 months after study treatment stop until death (approximately up to 2.5 years))
- Time to Progression Free Survival [PFS] on Next-line Therapy (PFS 2)(Every 3 months after study treatment stop (follow-up) until progression under the next line therapy (approximately up to 2.5 years))
- Symptomatic PFS Based on Number of Subjects Who Had Symptomatic Progression or Death(Every 8 weeks until symptomatic or radiological progression documentation (approximately up to 2.5 years))
- Time to Further Anticancer Treatment for Prostate Cancer(Every 3 months after study treatment stop until further anticancer therapy for prostate cancer (approximately up to 2.5 years))
- Time to Deterioration in Functional Assessment of Cancer Therapy - Prostate (FACT-P)(Up to End of Study visit (approximately up to 2.5 years))
- Change From Baseline of EuroQol-5 Dimension QoL Instrument (EQ-5D) VAS Score(Baseline and End-of-study Visit (approximately up to 2.5 years))
- Safety Profile of Tasquinimod(At regular intervals during the study treatment period and every 3 months during the follow-up until death (approximately up to 2.5 years))