Phase II dose titration study of regorafenib for patients with unresectable metastatic colorectal cancer who are progressed after standard chemotherapy
- Conditions
- unresectable metastatic colorectal cancer
- Registration Number
- JPRN-UMIN000018968
- Lead Sponsor
- Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
1) Prior treatment with regorafenib. 2) Previous or concurrent cancer that is distinct in primary site or histology form colorectal cancer within 5 years prior to randomization EXCEPT for curatively treated cervicalcancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta, Tis and T1]. 3) Major surgical procedure within 28 days before start of study medication. 4) Pregnant or breast-feeding patients. Woman of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of treatment. 5)Congestive heart failure >=NYHA class 2. 6) Unstable angina, new-onset angina. Myocardial infarction less than 6 months before start of study medication. 7)Uncontrolled hypertension. 8) Pleural effusion or ascites with dyspnea higher than CTCAE v4.0 grade 2. 9) Arterial or venous thrombotic or embolic events such as cerebrovascular accident, deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication. 10) Known history of HIV infection, or chronic hepatitis B or C. 12) Symptomatic metastatic brain or meningeal metastasis. 13) Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event >= CTCAE v4.0 Grade 3 within 4 weeks of start of study medication. 14) Interstitial lung disease with ongoing sings and symptoms at the time of informed consent. 15) Persistant proteinuria of CTCAE v4.0 Grade 3 or higher. 16) Patients unable to swallow oral medications. 17) Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation. 18) Non-healing wound, ulcer, or bone fracture. 19) Unsolved toxicity higher than CTCAE v4.0 Grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity <= Grade 2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method