临床试验/NCT01253369

NCT01253369已完成2 期

A Phase II Study of Pazopanib in Patients With Relapsed or Refractory Small Cell Lung Cancer (SCLC)

Dana-Farber Cancer Institute3 个研究点分布在 1 个国家目标入组 33 人开始时间: 2010年6月最近更新: 2019年4月23日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Dana-Farber Cancer Institute
入组人数: 33
试验地点: 3
主要终点: 8-Week Progression-Free Rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Pazopanib is a drug that inhibits proteins thought to be important for new blood vessel formation. This drug has been used in other cancer research studies and information from those studies suggests that pazopanib may help block proteins that are important for the growth, invasion, and spread of cancer cells.

详细描述

OBJECTIVES:

Primary

To determine the progression-free survival rate in participants with relapsed or refractory small cell lung cancer who have received one prior regimen of systemic chemotherapy at 8 weeks

Secondary

To determine the response rate (as measured by RECIST 1.1 criteria and changes in blood flow/perfusion as measured by perfusion CT)
To determine median and overall survival
To characterize the toxicity profile of pazopanib in this patient population.

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: All
接受健康志愿者: 否

入选标准

•Diagnosis of small cell neuroendocrine carcinoma based on either histology or cytology with radiologically-confirmed progressive disease.
•Participants should have received first-line chemotherapy and may have had up to two prior chemotherapy regimens. Radiation therapy may have been part of the permitted prior therapy.
•Participants with brain metastases will be allowed if they have been treated with surgery and/or radiation therapy more than 21 days prior, are asymptomatic, and are stable for at least one week off steroids.
•18 years of age or older
•ECOG Performance status of 0, 1 or 2
•Ability to swallow and retain oral medication
•Disease must be measurable according to RECIST 1.1
•Adequate organ function as defined in the protocol

排除标准

•Prior malignancy except for participants that have been disease-free for 3 years or with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma
•History or clinical evidence of central nervous system metastases or leptomeningeal carcinomatosis except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for one week prior to first dose of study drug.
•Clinically significant gastrointestinal abnormalities
•Presence of uncontrolled infection
•Prolongation of corrected QT interval (QTc) > 480msecs
•History of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting; myocardial infarction; unstable angina; symptomatic peripheral vascular disease; Class III or IV congestive heart failure
•Poorly controlled hypertension
•History of cerebrovascular accident including transient ischemic attack, pulmonary embolism or insufficiently treated deep venous thrombosis within the past 6 months
•Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture or ulcer
•Evidence of active bleeding or bleeding diathesis
•Hemoptysis in excess of 2.5mL within 6 weeks of first dose of study drug
•Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
•Use of any prohibited medication within the timeframes listed in the protocol
•Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug
•Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors
•Is now undergoing and/or has undergone in the 14 days immediately prior to first dose of study drug, any cancer therapy
•Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is progressing in severity
•Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib

研究组 & 干预措施

Pazopanib

Experimental

Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.

干预措施: Pazopanib (Drug)

结局指标

主要结局

8-Week Progression-Free Rate

时间窗: For this endpoint, disease was evaluated radiologically at baseline and week 8 on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-20).

The 8-week progression free rate (PFR) was defined as achieving complete response (CR), partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria by the time of the first disease assessment (8 weeks). Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions; PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; and SD is neither sufficient decrease to qualify as PR nor sufficient increase to qualify as progressive disease (PD). PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. Response needed confirmation within 4 weeks. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions.

次要结局

Objective Response Rate(Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-20).)

研究者

发起方

Dana-Farber Cancer Institute

申办方类型

Other

责任方

Principal Investigator

主要研究者

David M. Jackman, MD

Principal Investigator

Dana-Farber Cancer Institute

研究点 (3)

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