JRCT ID: jRCTs031180104
Registered date:04/02/2019
PhaseII study investigating efficacy and safety of TFTD plus bevacizumab by RAS mutation status in patients with unresectable advanced or recurrent colorectal cancer refractory or intolerant to standard chemotherapy (JFMC51-1702-C7)
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Colorectal cancer |
Date of first enrollment | 23/01/2018 |
Target sample size | 100 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | TFTD: 35 mg/m. given orally twice daily on days 1-5 and 8-12 in a 28-day cycle, Bevacizumab: 5 mg/kg, administered by intravenous infusion for 30 min every 2 weeks |
Outcome(s)
Primary Outcome | Disease control rate (DCR) by RAS mutation status |
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Secondary Outcome | DCR in full analysis set, Progression-free survival, Overall survival, Objective response rate, Safety, Efficacy and safety by the BRAF mutation status (exploratory outcome) |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1.Histologically confirmed advanced or recurrent colorectal adenocarcinoma (exclude appendix and anal cancer) 2.Unresectable colorectal cancer confirmed by imaging 3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4.Confirmed RAS mutation status 5.Treatment history of one or more regimens of standard chemotherapy (1) Refractory or intolerant to fluoropyrimidine, irinotecan, oxaliplatin, angiogenesis inhibitor (bevacizumab, ramucirumab, or aflibercept), and anti-EGFR antibody (cetuximab or panitumumab) for wild-type RAS (2) Exclude history of intolerance to bevacizumab (3)Include history of adjuvant chemotherapy if a tumor had relapsed within 6 months after the last administration 6 No treatment history of regorafenib and TFTD 7.Measurable lesions based on the Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) within the 21 days before enrolment 8.Adequate bone marrow, hepatic, and renal functions 9.Written informed consent |
Exclude criteria | 1.History of intolerance to bevacizumab 2.Thromboembolic events within the 6 months before enrolment 3.Active bleeding 4.Severe heart disease within the 6 months before enrolment 5.Cerebrovascular events 6.Active infections 7.Ascites, pleural effusion, or pericardial effusion requiring treatment 8.Gastrointestinal obstruction, renal failure, or liver failure 9.Uncontrolled diabetes mellitus 10.Uncontrolled hypertension 11.Positive for Hepatitis B surface antigen (HbsAg+) or Hepatitis C antibody (HCV Ab+) 12.Other active cancer 13.Symptomatic brain metastases 14.Requiring immunosuppressive treatment due to an autoimmune disorder or history of organ transplantation 15.Treatment history; (1)Major surgery (i.e., thoracotomy or laparotomy) within the 4 weeks before enrollment (2)Chemotherapy within the 2 weeks before enrollment (3)Extensive exposure of radiation within the 4 weeks before enrollment 16.Unresolved adverse events of grade 2 or higher (classified with the National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) from previous treatment 17.Unhealed wound or traumatic fracture 18.tendency of haemorrhage and undergoing treatment with an antithrombotic drug (including a daily dose of 325 mg or more of oral aspirin) 19.Females who are in pregnancy, breastfeeding, with a positive pregnancy test or unwilling to use adequate contraception or males of reproductive potential 20.Clinically significant mental or psychological disorder 21.Patients whose participation in the trial was judged to be inappropriate by the investigator |
Related Information
Primary Sponsor | Takahashi Takao |
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Secondary Sponsor | Yamazaki Kentaro,Oki Eiji |
Source(s) of Monetary Support | TAIHO PHARMACEUTICAL CO., LTD. |
Secondary ID(s) | UMIN000030077 |
Contact
Public contact | |
Name | Takao Takahashi |
Address | 1-1 Yanagido, Gifu city, GIFU Gifu Japan 501-1194 |
Telephone | +81-58-230-6231 |
takaota@gifu-u.ac.jp | |
Affiliation | Gifu University Hospital |
Scientific contact | |
Name | Takao Takahashi |
Address | 1-1 Yanagido, Gifu city, Gifu Gifu Japan 501-1194 |
Telephone | +81-58-230-6231 |
takaota@gifu-u.ac.jp | |
Affiliation | Gifu University Hospital |