NCT01380769已完成2 期
A Randomized, Phase 2, Study to Assess the Safety and Activity of CRLX101, a Nanoparticle Formulation of Camptothecin, in Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed One or Two Previous Regimens of 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
- 157
- 试验地点
- 25
- 主要终点
- To Compare Overall Survival of Patients Treated With CRLX101 + BSC to Those Patients Treated With BSC Only
研究概览
简要总结
The purpose of this study is to compare median overall survival of patients with advanced non-small cell lung cancer (NSCLC) treated with CRLX101 to patients treated with best supportive care (BSC).
详细描述
Lung cancer remains the leading cause of cancer-related mortality in men and women worldwide. Non-small cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancer. The development of targeted therapies has changed the approach to treating NSCLC significantly over the past decade with targeted therapies generally possessing safety advantages over traditional cytotoxic regimens. However, combination paradigms and resistance patterns complicate the use of these agents. CRLX101 is a nanoparticle comprised of camptothecin (CPT) conjugated to a cyclodextrin-based polymer. CRLX101 is designed to increase the exposure of tumor cells to CPT while minimizing side effects.
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
- •Male or female patients who are ≥ 18-years of age.
- •Histologically or cytologically confirmed, locally advanced or metastatic NSCLC (adenocarcinoma, bronchoalveolar, squamous cell, large cell, or mixed carcinoma) that is not amendable to surgical treatment and patient has have failed 1 or 2 different lines of chemotherapy.
- •Measureable disease and evidence of progression on the previous therapy. Progression may be clinical or radiological.
- •ECOG performance status of 0 or
- •Life expectancy of at least 3 months.
- •Hemoglobin ≥ 10 g/dL.
- •Absolute neutrophil count (ANC) ≥ 1500 cells/µL without growth factor support.
- •Platelet count ≥ 100,000 cells/µL without support.
- •Adequate hepatic and renal function including the following: Total bilirubin < 2 × ULN, AST or ALT ≤ 2.5 × ULN or ≤ 5 × ULN for patients with liver metastasis, PTT within normal limits, INR ≤ 1.5, Serum Creatinine <1.5 ULN
- •At least 4 weeks post any radiotherapy or biological therapy; at least 6 weeks post nitrosoureas therapy.
- •Full recovery from diagnostic or therapeutic surgery (i.e., complete wound healing) and at least 30 days have elapsed prior to initial dosing.
- •Full recovery from the toxic effects of prior therapy (i.e., Common Toxicity Criteria [CTC] Grade 1 or less with the exception of Grade 2 alopecia).
- •Women of childbearing potential must have adequate pregnancy test. If postmenopausal, must be ≥ 12 months since last menses.
- •Women of childbearing potential and men must agree to use an effective form of contraception during the study and for 60 days after the last dose of study drug.
排除标准
- •CNS metastases by radiologic evidence or histology, unless clinically stable (must have been treated by resection or radiation) for at least 4 weeks prior to first dose of study drug. Patients may not be receiving dexamethasone for control of CSF pressure.
- •Concurrent therapeutic anticoagulation: PTT less than or equal to 1.5 × ULN or low dose aspirin and low-weight heparin only are allowed.
- •More than 2 previous lines of chemotherapy for lung cancer. This includes biologic (immunotherapy) therapy.
- •History of previous cerebrovascular accident (CVA) or history transient ischemic attack (TIA) within 6 months of study entry.
- •History of prior malignancy not cured by excision. Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are not excluded, but patients with other prior malignancies must have had at least 2-year disease free interval.
- •Recent history (within 6 months of screening) of unstable angina, myocardial infarction, or NYHA Class III or IV congestive heart failure
- •History of cardiac arrhythmia requiring medical or electrical therapy.
- •QTc > 450 msec for males and > 470 msec for females.
- •Any major surgery within 30 days or minor surgery within 10 days of study entry, or patient not recovered from surgery.
- •History of organ or bone marrow transplant.
- •Known active and/or uncontrolled infection, including HIV and are not stable on antiretroviral therapy.
- •Any investigational therapy within 28 days of study entry.
- •Pregnant or nursing.
- •Anyone who in the judgment of the investigator cannot comply with the protocol, provide truly informed consent, or is likely to live < 90 days
- •Severe or significant allergy to any chemotherapy or premedication.
- •Clinically evident ascites (e.g., abdominal distention, bulging and/or fluid wave) or Grade 3 peripheral edema.
- •Any prior cancer treatment with a topoisomerase I inhibitor.
研究组 & 干预措施
CRLX101
Experimental
干预措施: CRLX101 (Drug)
Best supportive care
Other
干预措施: Best Supportive Care (Other)
结局指标
主要结局
To Compare Overall Survival of Patients Treated With CRLX101 + BSC to Those Patients Treated With BSC Only
时间窗: Up to 18 months
Comparison of survival among patients treated with CRLX101 + best supportive care vs patients treated wiht best supportive care only.
次要结局
- Assess Objective Response Rate (ORR) of CRLX101+ BSC Compared to BSC Only(12 months)
研究者
研究点 (25)
Loading locations...
相似试验
已完成
2 期
GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without NivolumabPreviously Treated Metastatic Adenocarcinoma of the PancreasNCT02243371Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins93
已完成
2 期
PEAK: Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer (mCRC) Patients With Wild-Type Kirsten Rat Sarcoma-2 Virus (KRAS) TumorsRectal CancerMetastatic Colorectal CancerColorectal CancerColon CancerNCT00819780Amgen285
招募中
2 期
IT or IA Infusion of PD1/PDL1/CTLA4 Inhibitors Versus IV for Immunotherapy of Head/Neck Cancers (HNC)Head/Neck NeoplasmNCT03952065Second Affiliated Hospital of Guangzhou Medical University200
招募中
3 期
Infusion of PD1/PDL1/CTLA4 Inhibitors Via Hepatic Arterial for Immunotherapy of Hepatocellular CarcinomaLiver CancerNCT03949231Second Affiliated Hospital of Guangzhou Medical University200
Unknown
2 期
Haploidentical and Mismatched Unrelated Donors Hematopoietic Stem Cell TransplantHematopoietic Stem Cell TransplantNCT03250546Assistance Publique - Hôpitaux de Paris184