JPRN-UMIN000030077
Completed
Phase 2
Phase II 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 - 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)
Japanese Foundation for Multidisciplinary Treatment of Cancer0 sites102 target enrollmentJanuary 9, 2018
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Japanese Foundation for Multidisciplinary Treatment of Cancer
- Enrollment
- 102
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion 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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 2
Trifluridine/tipiracil (FTD/TPI) plus ramucirumab (Ram) for advanced gastric cancergastric cancerGastric cancerJPRN-jRCTs041210105Kodera Yasuhiro32
Completed
Phase 2
Phase II study assessing the efficacy and safety of lenvatinib for anaplastic thyroid cancer (HOPE)JPRN-UMIN000020773Translational Research Informatics Center, Foundation for Biomedical Research and Innovation39
Completed
Phase 2
A phase II study to evaluate efficacy and safety of Bevacizumab combined with Cisplatin and S-1 for Advanced Non-Squamous Non-Small-Cell Lung Cancernon-squamous non-small-cell lung cancerJPRN-UMIN000009476The Tokyo cooperative oncology group39
Active, not recruiting
Phase 2
Phase II study of allogeneic transplantation using transplant-lite conditioning regimesMetastatic renal cancerHaematological malignancyCancer - Haematological diseasesACTRN12605000536662Dr James Morton80
Not yet recruiting
Phase 2
Phase II Study to evaluate efficacy and safety of Lenalidomide maintenance therapy for multiple myeloma patients under bortezomib treatmentmultiple myelomaJPRN-UMIN000013881ational Defense Medical College29