Regorafenib given to patients with metastatic colorectal cancer (CRC) who have failed all available standard therapy

Phase 1

• Conditions: Colorectal neoplasms; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005836-25-SE
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-04
• Study Completion: 2015-01-02
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 2872

Inclusion Criteria

•Male or female subjects ³ 18 years of age.
•Life expectancy of at least 3 months
•Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
•Subjects with metastatic colorectal cancer (Stage IV).
•Progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan,bevacizumab and cetuximab/panitumumab (if KRAS WT) (WT: wild type)
•ECOG Performance Status of = 1 (ECOG: Eastern Cooperative Oncology Group)
•Adequate bone marrow, liver and renal function
•Women of childbearing potential and men must agree to use adequate contraception

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 1650
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1350

Exclusion Criteria

•Prior treatment with regorafenib.
•Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication treatment
•Pregnant or breast-feeding subjects.
•Congestive heart failure ³ New York Heart Association (NYHA) class 2.
•Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months).
•Myocardial infarction less than 6 months before start of study drug.
•Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
•Uncontrolled hypertension. (Systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
•Pleural effusion or ascites that causes respiratory compromise (³ CTCAE Grade 2 dyspnea). (CTCAE: common terminology criteria for adverse events)
•Ongoing infection > Grade 2 CTCAE v. 4.0.
•Known history of human immunodeficiency virus (HIV) infection.
•Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy.
•Subjects with seizure disorder requiring medication.
•Subjects with evidence or history of any bleeding diathesis, irrespective of severity.
•Any hemorrhage or bleeding event ³ CTCAE Grade 3 within 4 weeks prior to the start of study medication.
•Non-healing wound, ulcer, or bone fracture.
•Renal failure requiring hemo-or peritoneal dialysis.
•Dehydration CTCAE v. 4.0 Grade ³ 1.
•Interstitial lung disease with ongoing signs and symptoms
•Persistent proteinuria of CTCAE Grade 3 (>3.5g/24 hours).
•Any malabsorption condition.
•Unresolved toxicity higher than CTCAE (v. 4.0) Grade 1 attributed to any prior therapy/procedure excluding alopecia, hypothyroidism and oxaliplatin induced neurotoxicity £ Grade 2.
•Concomitant participation or participation within the last 30 days in another clinical trial
•Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 weeks (or within 6 weeks for mitomycin C) before starting to receive study medication.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified