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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002222-37-DK

Enrollment

Registered

2016-06-20

Start date

2016-09-07

Completion date

Unknown

Last updated

2018-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient with metastatic colorectal cancer MedDRA version: 19.0 Level: LLT Classification code 10010028 Term: Colorectal cancer Duke's D System Organ Class: 100000004864

Interventions

Product Name: bevacizumab Pharmaceutical Form: Infusion INN or Proposed INN: BEVACIZUMAB CAS Number: 216974-75-3 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Overall survival between the two groups ;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

Measure	Time frame
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	—

Countries

Denmark

Contacts

Public ContactDorte Nielsen

Oncology dept. Herlev og Gentofte Hospital

dorte.nielsen@regionh.dk+4538682344

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026