Phase II Study of Dovitinib and Pilot Study of Fibroblast Growth Factor Receptor Biomarkers in Advanced Non-Small Cell Lung Cancer or Advanced Colorectal Cancer Previously Treated With Anti-Vascular Endothelial Growth Factor Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
The purpose of this study is to find out if dovitinib is an effective treatment for patients with advanced lung cancer or advanced colorectal cancer (CRC) who have progressed on anti-vascular endothelial growth factor (VEGF) treatment.
详细描述
The purposes of this study are 1) to evaluate the clinical efficacy of dovitinib and 2) to prospectively estimate the prevalence of fibroblast growth factor (FGF) signaling alterations in patients with advanced non-squamous non small cell lung cancer (NSCLC) or advanced CRC who have progressed on anti-VEGF treatment. Additionally, the investigators will make exploratory initial observations of the relationship between FGF signaling alterations and the clinical activity of dovitinib. This trial is expected to provide key biologic information that will inform the clinical development of dovitinib and provide initial evaluation of the analytic characteristics of these potential predictive biomarkers of its efficacy.
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
- •Histologically confirmed non-small cell lung cancer or colorectal cancer for which no potentially curative treatment options are available
- •Any number of prior treatment regimens are allowed
- •Immediate prior treatment regimen must have included an anti-VEGF agent. Acceptable anti-VEGF therapy includes bevacizumab, sunitinib, or sorafenib. For other anti-VEGF therapies, contact the principal investigator.
- •Last dose administered of bevacizumab must be at least 21-days but not more than 56-days from enrollment.
- •Last dose of anti-VEGF tyrosine kinase inhibitor must be at least 7-days but not more than 56-days from enrollment.
- •Willingness to consent to research biopsy
- •Measurable disease by RECIST 1.1 criteria
- •Available tumor site amenable to core needle biopsy as determined by the treating investigator. Any questions regarding suitability of site for biopsy will be adjudicated by the principal investigator.
- •Zubrod (ECOG) performance status 0 or 1
- •Age ≥ 18 years old
- •Patients who give a written informed consent
- •Patients must have the following laboratory values:
- •Platelets ≥ 100 x 109/L
- •Absolute neutrophil count ≥ 1.5 x 109/L Hemoglobin > 9 g/dL
- •Serum total bilirubin: ≤ 1.5 x upper limit of normal ULN
- •ALT and AST ≤ 3.0 x ULN ( with or without liver metastases)
- •Serum creatinine ≤ 1.5 x ULN or serum creatinine >1.5 - 3 x ULN
排除标准
- •Patients with known brain metastases
- •Patients with another primary malignancy within 3 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or skin cancer
- •Patients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies that have not resolved to NCI CTCAE grade 1 or less.
- •Patients who have received the last administration of nitrosurea or mitomycin-C ≤ 6 weeks prior to starting study drug, or who have side effects that have not resolved to NCI CTCAE grade 1 or less.
- •Patients who have received targeted therapy ≤ 1 week prior to starting study drug, or who have not recovered from the side effects of such therapy
- •Patients who have had radiotherapy ≤ 4 weeks prior to starting study drug, or ≤ 2 weeks prior to starting study drug in the case of localized radiotherapy or who have not recovered from radiotherapy toxicities
- •Patients who have undergone major surgery, open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
- •Patients with any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
- •Impaired cardiac function or clinically significant cardiac diseases
- •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib
- •Cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- •Known diagnosis of human immunodeficiency virus infection
- •Patients who are currently receiving anticoagulation treatment with therapeutic doses of warfarin
- •Other concurrent severe and/or uncontrolled concomitant medical conditions
- •Pregnant or breast-feeding women
- •Women of child-bearing potential, who are biologically able to conceive, not employing two forms of highly effective contraception.
- •Fertile males not willing to use contraception, as stated above
- •Patients unwilling or unable to comply with the protocol
研究组 & 干预措施
Dovitinib
500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
干预措施: Dovitinib (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Up to 100 months
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
- Disease Control Rate(From start of treatment, up to 8 weeks)
- Progression Free Survival(From start of treatment until the date of death from any cause, assessed up to 100 months)
- Number of Patients Who Experienced Treatment Related Toxicities(Starting at screening and then at every visit and then up to 30 days after the last dose of study treatment.)