NCT01204710已完成2 期
A Randomized Phase 2 Study of Human Anti-PDGFRα Monoclonal Antibody IMC-3G3 Plus Mitoxantrone Plus Prednisone or Mitoxantrone Plus Prednisone in Metastatic Castration-Refractory Prostate Cancer Following Disease Progression or Intolerance on Docetaxel-based Chemotherapy
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
- 123
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This is a study evaluating the safety and efficacy of the monoclonal antibody olaratumab plus mitoxantrone plus prednisone compared to mitoxantrone plus prednisone in metastatic castration-refractory prostate cancer following disease progression or intolerance on docetaxel-based chemotherapy.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •histologically-confirmed adenocarcinoma of the prostate
- •radiographic evidence of metastatic prostate cancer (Stage M1 or D2)
- •has prostate cancer unresponsive or refractory to medical or surgical castration with a serum testosterone level of <50 nanograms per milliliter (ng/mL)
- •has had disease progression or intolerance on docetaxel-based therapy
- •prostate-specific antigen (PSA) ≥10 ng/mL
- •all clinically significant toxic effects of prior surgery, radiotherapy, chemotherapy or hormonal therapy have resolved to ≤Grade 1, based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.02
- •participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- •adequate hematologic function
- •adequate hepatic function
- •adequate renal function
- •urinary protein is ≤1 on dipstick or routine analysis
- •life expectancy of more than 3 months
- •fertile man with partners that are women of childbearing potential must use an adequate method of contraception during the study
- •signed Informed Consent Document
排除标准
- •concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive or in situ neoplasms
- •The participant has received more than 1 prior cytotoxic chemotherapy regimen for metastatic disease
- •prior therapy with mitoxantrone for advanced prostate cancer
- •The participant has a history of symptomatic congestive heart failure or has a pre study echocardiogram or multigated acquisition scan with left ventricular ejection fraction that is ≥10% below the lower limit of normal institutional range
- •history of prior treatment with other agents that directly inhibit platelet-derived growth factor (PDGF) or platelet-derived growth factor receptors (PDGFR)
- •known allergy to any of the treatment components: olaratumab, mitoxantrone, and/or prednisone
- •radiotherapy within 21 days prior to first dose of olaratumab
- •any investigational therapy within 30 days of randomization
- •is receiving corticosteroids at a dose >5 mg prednisone PO BID or equivalent
- •received prior strontium-89, rhenium-186, rhenium-188, or samarium-153 radionucleotide therapy and has either ongoing evidence of bone marrow dysfunction or poorly controlled bone pain
- •has any ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, psychiatric illness, active bleeding or pathological condition that carries a high risk of bleeding, or any other serious uncontrolled medical disorders
- •known or suspected brain or leptomeningeal metastases
- •known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
研究组 & 干预措施
Olaratumab + Mitoxantrone
Experimental
1 cycle = 3 weeks (21 days)
干预措施: Olaratumab (Biological)
Olaratumab + Mitoxantrone
Experimental
1 cycle = 3 weeks (21 days)
干预措施: Mitoxantrone (Drug)
Olaratumab + Mitoxantrone
Experimental
1 cycle = 3 weeks (21 days)
干预措施: Prednisone (Drug)
Mitoxantrone: Optional Olaratumab Monotherapy
Active Comparator
1 cycle = 3 weeks (21 days)
Participants who experience progressive disease (PD) have the option to receive olaratumab monotherapy treatment.
干预措施: Mitoxantrone (Drug)
Mitoxantrone: Optional Olaratumab Monotherapy
Active Comparator
1 cycle = 3 weeks (21 days)
Participants who experience progressive disease (PD) have the option to receive olaratumab monotherapy treatment.
干预措施: Prednisone (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Randomization to Measured PD or Death Due to Any Cause Up to 23 Months
PFS is measured from randomization to the earliest date of the following events: PD according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version (v) 1.1, is a ≥20% increase in the sum of diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 millimeter (mm), the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions, unequivocal evidence of progression by bone scan, clinical progression or death from any cause. For participants who had no documented PD or death or had started new anti-cancer therapy or were lost to follow-up, PFS was censored at their last tumor assessment.
次要结局
- PFS Based on Baseline Circulating Tumor Cells (CTC) Counts(Randomization to Measured PD or Death Due to Any Cause Up to 23 Months)
- OS Based on Baseline CTC Counts(Randomization to Death Due to Any Cause Up to 36 Months)
- Maximum Concentration (Cmax) of Olaratumab Cycles 1, 2 and 3(Day 1 of Cycles 1, 2 and 3, and Day 8 of Cycles 1 and 3 (21-day cycle))
- Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)](Randomization to Objective PD or Death Up to 23 Months)
- Percentage of Participants With a ≥50% Decrease in Prostate Specific Androgen (PSA) From Pretreatment to Any Time(Pretreatment to PD Up to 23 Months)
- Overall Survival (OS)(Randomization to Death Due to Any Cause Up to 36 Months)
- Percentage of Participants With Anti-Olaratumab Antibody Assessment (Immunogenicity)(From Start of Treatment up to 9 Months)
- Percentage of Participants With a ≥30% Decrease in PSA From Pretreatment to Week 12(Pretreatment through Week 12)
- Summary Listing of Participants Reporting Treatment-Emergent Adverse Events (TEAE)(From Start of Treatment Through Study Completion Up to 36 months)
- Number of Participants With Negative Platelet-Derived Growth Factor Receptor Alpha (PDGFRα) Protein Expression by Immunohistochemistry (IHC)(Baseline)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
Randomized Phase 2 study of the human monoclonal antibody IMC-3G3 plus a typically used chemotherapy regimen of Mitoxantrone plus Prednisone or the respective chemotherapy regimen alone in patients with prostate cancer that do no longer respond to or showed unbearable toxicity of docetaxel chemotherapy.Metastatic Castration-Refractory Prostate CancerMedDRA version: 14.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-018015-11-BEImClone LLC120
进行中（未招募）
不适用
Randomized Phase 2 study of the human monoclonal antibody IMC-3G3 plus a typically used chemotherapy regimen of Mitoxantrone plus Prednisone or the respective chemotherapy regimen alone in patients with prostate cancer that do no longer respond to or showed unbearable toxicity of docetaxel chemotherapy.EUCTR2009-018015-11-DEImClone LLC120
进行中（未招募）
不适用
Randomized Phase 2 study of the human monoclonal antibody IMC-3G3 plus a typically used chemotherapy regimen of Mitoxantrone plus Prednisone or the respective chemotherapy regimen alone in patients with prostate cancer that do no longer respond to or showed unbearable toxicity of docetaxel chemotherapy.EUCTR2009-018015-11-CZImClone LLC120
进行中（未招募）
不适用
Randomized Phase 2 study of the human monoclonal antibody IMC-3G3 plus a typically used chemotherapy regimen of Mitoxantrone plus Prednisone or the respective chemotherapy regimen alone in patients with prostate cancer that do no longer respond to or showed unbearable toxicity of docetaxel chemotherapy.Metastatic Castration-Refractory Prostate CancerMedDRA version: 14.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-018015-11-HUImClone LLC120
进行中（未招募）
不适用
A Randomized Phase 2 Study of Human Anti-PDGRFa Monoclonal Antibody IMC-3G3 plus Mitoxantrone plus Prednisone or Mitoxantrone plus Prednisone in Metastatic Castration-Refractory Prostate Cancer (CRPC) Following Disease Progression or Intolerance on Docetaxel-based Chemotherapy. - NDMetastatic Castration Refractory Prostate CancerMedDRA version: 12.1Level: LLTClassification code 10007453Term: Carcinoma of the prostate metastaticEUCTR2009-018015-11-ITIMCLONE LLC120