A Phase II Study Investigating Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 19
- 主要终点
- Progression-Free Survival (PFS) rate at 6 months
研究概览
简要总结
This is an open-label multicenter, single-arm Phase II study of Fruquintinib in combination with FOLFIRI (leucovorin calcium (folinic acid), fluorouracil, and irinotecan) in participants with metastatic colorectal cancer (mCRC). The main goals of this study are to:
- Evaluate the efficacy of the combination of fruquintinib + FOLFIRI in the 2nd-line mCRC setting
- Evaluate the safety of the combination of fruquintinib + FOLFIRI
详细描述
Fruquintinib is an FDA approved cancer medication that works by targeting proteins called vascular endothelial growth factor receptors (VEGFRs). VEGFRs are important in the creation of new blood vessels. As a highly-selective and potent VEGFR inhibitor, fruquintinib helps block new blood vessels that would provide nutrients and oxygen to cancerous tumors from forming. It is a small molecule anti-tumor drug with a novel chemical structure that belongs to the quinazoline class.
This study is an open-label Phase II study designed to evaluate the efficacy and safety of fruquintinib + FOLFIRI in 2nd-line setting mCRC participants who have been previously treated with oxaliplatin, a fluoropyrimidine, and bevacizumab (BEV) for first line of therapy. Up to 60 participants will receive concurrent fruquintinib and FOLFIRI according to standard guidelines of treatment of mCRC.
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
- •Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectum with at least one measurable lesion according to RECIST v
- •Genetic aberrations are allowed, except for microsatellite instability high (MSI-H) and BRAF V600
- •Participants must have received first-line therapy for mCRC that included oxaliplatin, a fluoropyrimidine, and a BEV-based agent. FOLFOXIRI, BEV, and SOX/BEV regimes are not permitted. A minimum of 2 cycles of first line of therapy must have been completed.
- •At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2
排除标准
- •Current treatment with other anticancer treatments within 21 days of the first dose of study treatment
- •Major surgery within 4 weeks of the first planned dose of study treatment
- •More than one prior systemic treatment for mCRC or any prior systemic treatment including FOLFIRI or irinotecan-based therapy.
- •Participants who received oxaliplatin and fluoropyrimidine in the first line neoadjuvant or adjuvant setting (prior to Metastatic diagnosis) and progressed within 6 months are not eligible due to lack of BEV exposure.
- •Uncontrolled, symptomatic brain metastases
- •Uncontrolled, symptomatic gastrointestinal disease
- •Participants with uncontrolled hypertension
- •Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 6 months after the last administration of study chemotherapy
- •Men who plan to father a child while in the study and for at least 6 months after the last administration of study chemotherapy
- •Documented major electrocardiogram (ECG) abnormalities which are clinically significant.
- •Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment
- •Presence of other active invasive cancers other than the one treated in this study within 5 years prior to screening
研究组 & 干预措施
Fruquinitinib + FOLFIRI
Participants will receive an assigned dose level of fruquintinib in combination with FOLFIRI. Cycles will be 28 days, where participants will take fruquinitinib orally on Days 1 through 21 in combination with FOLFIRI intravenous infusion (IV) every 2 weeks. Up to 60 participants will be enrolled.
干预措施: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) (Drug)
Fruquinitinib + FOLFIRI
Participants will receive an assigned dose level of fruquintinib in combination with FOLFIRI. Cycles will be 28 days, where participants will take fruquinitinib orally on Days 1 through 21 in combination with FOLFIRI intravenous infusion (IV) every 2 weeks. Up to 60 participants will be enrolled.
干预措施: fruquintinib (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) rate at 6 months
时间窗: Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.
Progression-Free Survival (PFS) rate at 6 months, defined as the percentage of participants at 6 months who have not experienced disease progression as defined by the RECIST Version 1.1 criteria or death on study. Participants who are alive and free from disease progression will be censored at the date of last tumor assessment.
次要结局
- Overall Response Rate (ORR)(Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.)
- Duration of response (DoR)(Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.)
- Disease control response rate (DCR)(Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.)
- Number of participants with treatment emergent adverse events(Every 28 day cycle, from signed informed consent to 30 days after treatment discontinuation up to 1 year.)
- Overall Survival (OS)(From cycle 1 day 1 up to 2 years)