NCT01533246已完成2 期
A Phase 2 Study of OSI-906 in Patients With Asymptomatic or Mildly Symptomatic (Non-Opioid Requiring) Metastatic Castrate Resistant Prostate Cancer (CRPC)
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
- 17
- 试验地点
- 2
- 主要终点
- PSA Response Analyzed Using the PCWG2 Definition
研究概览
简要总结
This phase II trial studies how well linsitinib works in treating patients with asymptomatic or mild symptomatic metastatic prostate cancer. Linsitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate time to prostate-specific antigen (PSA) progression based on Prostate Cancer Working Group (PCWG2) criteria.
II. To evaluate PSA response (proportion of patients achieving a PSA decline > 50% according to PCWG2 criteria in patients receiving linsitinib [OSI-906]).
III. To evaluate overall response rate (ORR) in patients with Response Evaluation Criteria in Solid Tumors (RECIST)-defined measurable disease receiving OSI-906.
SECONDARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate
- •Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM); if the patient is being treated with luteinizing hormone-releasing hormone (LHRH) agonists (patient who has not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to course 1 Day 1 and must be continued throughout the study
- •Metastatic disease documented by positive bone scan or metastatic lesions other than liver or visceral metastasis on computed tomography (CT) or magnetic resonance imaging (MRI); if lymph node metastasis is the only evidence of metastasis, it must be ≥ 2 cm in diameter
- •Prostate cancer progression documented by PSA according to PCWG2 or radiographic progression according to modified RECIST criteria
- •Asymptomatic or mildly symptomatic from prostate cancer; a score of 0-1 on Brief Pain Inventory (BPI)-Short Form (SF) Question #3 (worst pain in last 24 hours) will be considered asymptomatic, and a score of 2-3 will be considered mildly symptomatic
- •Patients who received combined androgen blockade or received second-line anti-androgen in the context of CRPC must have shown PSA progression after discontinuing the anti-androgen prior to enrollment (≥ 4 weeks since last flutamide, ≥ 6 weeks since last bicalutamide or nilutamide) and have progressive disease
- •No patients with known brain metastases
- •Understand and voluntarily sign an informed consent form
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Hemoglobin ≥ 10.0 g/dL independent of transfusion
- •Absolute neutrophil count ≥ 1,500/mcL
- •Platelet count ≥ 100,000/μL
- •Serum albumin ≥ 3.5 g/dL
- •Serum creatinine < 1.5 times upper limit of normal (ULN) OR a calculated creatinine clearance ≥ 60 mL/min
- •Serum potassium ≥ 3.5 mmol/L
- •Serum bilirubin < 1.5 times ULN (except for patients with documented Gilbert's disease)
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 times ULN
- •Able to swallow the study drug
- •Life expectancy of at least 6 months
- •Men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
- •No history of clinically significant heart disease as evidenced by myocardial infarction or arterial thrombotic events in the past 6 months, severe or unstable angina, New York Heart Association (NYHA) Class II-IV heart disease, or cardiac ejection fraction measurement of < 50% at baseline
- •No prolonged QTc > 470 msec (mean QTc with Bazett's correction) or history of familial long QT syndrome
- •No other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months
- •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-906
- •No uncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements
- •Patients with insulin-dependent diabetes are excluded
- •Patients with known history of HIV on combination antiretroviral therapy are ineligible
- •Patients with known infectious hepatitis A, B, or C are ineligible
- •No condition that, in the opinion of the investigator, would preclude participation in this trial
- •See Disease Characteristics
- •Prior therapy with ketoconazole and steroids is allowed provided patients have been off treatment for 4 weeks
- •Prior investigational agents with novel adrenal inhibitors (i.e., Abiraterone or TAK700) are allowed provided these agents have been discontinued at least 4 weeks prior to enrollment
- •Prior investigational agents with novel antiandrogens (i.e., MDV 3100) are allowed provided these agents have been discontinued at least 6 weeks prior to enrollment
- •Prior therapy with Sipuleucel-T is allowed provided patients have documented evidence of disease progression as stated above
- •Patients receiving any other hormonal therapy, including any dose of Megestrol acetate (Megace), Proscar (finasteride), any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES), or any systemic corticosteroid must discontinue the agent for at least 4 weeks prior to enrollment; progressive disease (as defined above) must be documented after discontinuation of the hormonal therapy
- •Patients on stable doses of bisphosphonates that show subsequent tumor progression may continue on this medication at the discretion of the treating physician; however, patients are not allowed to initiate bisphosphonate therapy within 4 weeks prior to starting therapy or throughout the study
- •No prior systemic chemotherapy for CRPC; prior neoadjuvant and adjuvant chemotherapy are allowed when completed at least 12 months prior to enrollment
- •No use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1
- •No prior use of IGF-1R inhibitors (monoclonal antibody or small molecule)
- •No palliative radiation therapy to bone metastasis or radionuclide therapy for treatment of metastatic CRPC within 4 weeks of Cycle 1 Day 1
- •Use of the potent CYP1A2 inhibitors ciprofloxacin and fluvoxamine are prohibited
- •Other less potent CYP1A2 inhibitors/inducers are not excluded
- •Supplements or complementary medicine/botanicals are not permitted while on protocol therapy, except for any combination of the following:
- •Conventional multivitamin supplements
- •Soy supplements
- •The use of concomitant steroids is not allowed unless patients are receiving physiological replacement disease for documented adrenal insufficiency
- •Use of drugs that have a known risk of causing Torsades de Pointes (TdP) are prohibited within 14 days prior to study enrollment
排除标准
- 未提供
研究组 & 干预措施
Treatment (linsitinib)
Experimental
Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.
干预措施: linsitinib (Drug)
Treatment (linsitinib)
Experimental
Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
PSA Response Analyzed Using the PCWG2 Definition
时间窗: 12 weeks
Number of patients with a PSA Response will be evaluated according to the recommendations from National Cancer Institute Prostate-Cancer Working Group 2 (PCWG2) criteria. PSA decline of at least 50% from baseline confirmed by a second measurement at least 4 weeks later.
次要结局
- Incidence of Toxicities Based on CTCAE Version 4.0 Criteria(Up to 2 years)
- Time to PSA Progression (TTPP) Analyzed Using the PCWG2 Definition(assessed up to 12 weeks)
- Number of Patients With Bidimensional Measurable Disease RECIST-based Response(Up to 2 years)
- Overall Survival Based on the RECIST v1.1(Up to 2 years)
- Progression Free Survival(assessed up to 2 years)
研究者
研究点 (2)
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