EUCTR2016-002222-37-DKActive, not recruitingPhase 1
A randomized phase II study between regorafenib and continuing biologic treatment to multi treated patients with colorectal cancer.
Herlev og Gentofte Hospital0 sites60 target enrollmentStarted: June 20, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Signed papers for participation
- •Age over 18 years
- •Performance status 0 or 1
- •Histological RAS wild-type adenocarcinoma colorectal cancer
- •Progressed during treatment with 5-FU, oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab. Treatment can have been stopped due to toxicity.
- •No more than 3 months since last treatment
- •Neutrophil granulocytes = 1.5 x 109 /l and thrombocytes = 75 x 109 /l
- •Bilirubin = 2 UNL
- •Creatinine clearance = 30 ml/min
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
Exclusion Criteria
- •Other malignity in the past 5 years
- •Other antineoplastic treatment
- •Severe illness
- •Not capable of taking pills
- •Uncontrolled infection
- •Females in the fertile age shall use anticonception
- •Do not understand the information
Investigators
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