A randomized phase II study between regorafenib and continuing biologic treatment to multi treated patients with colorectal cancer.

Phase 1

Conditions: Patient with metastatic colorectal cancer
MedDRA version: 19.0Level: LLTClassification code 10010028Term: Colorectal cancer Duke's DSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2016-002222-37-DK

Lead Sponsor: Herlev og Gentofte Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

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
•Pregnant
•Females in the fertile age shall use anticonception
•Do not understand the information

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Overall survival between the two groups<br>;Secondary Objective: Progression free survival, response, toxicity and Para clinical parameters, between the two groups;Primary end point(s): Overall survival between the two groups;Timepoint(s) of evaluation of this end point: 1 year after last patient are included

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Progression free survival, response, toxicity and Para clinical parameters, between the two groups;Timepoint(s) of evaluation of this end point: 1 year after last patient last visit