This clinical study evaluates the tumor response rate in patients with cancer of the colon or rectum who are receiving regorafenib in combination with chemotherapy.
- Conditions
- Metastatic adenocarcinoma of the colon or rectum (metastatic CRC)MedDRA version: 16.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-020121-41-GB
- Lead Sponsor
- Bayer Health Care AG, D-51368 Leverkusen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 54
•Male or female subjects aged = 18 years
•Histological or cytological documentation of adenocarcinoma of the colon or rectum
•Suitable to receive mFOLFOX6 regimen as first line metastatic treatment
•At least 1 measurable lesion as per RECIST version 1.1
•Unresectable or unlikely becoming resectable metastatic disease
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
•Life expectancy of at least 3 months
•Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to first dose of study treatment
•Total bilirubin = 1.5 x the upper limit of normal (ULN)
•Alanine transaminase (ALT) and aspartate aminotransferase (AST) = 2.5 x ULN (= 5 x ULN for subjects with liver involvement of their cancer)
•Lipase = 1.5 x the ULN
•Serum creatinine = 1.5 x the ULN
•Glomerular filtration rate (GFR) = 60 mL/min/1.73 m2 according to the modified diet in renal disease (MDRD) abbreviated formula
•International normalized ratio (INR)/partial thromboplastin time (PTT) = 1.5 x ULN. (Subjects who are being therapeutically anticoagulated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in this parameter exists. Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is predose as defined by the local standard of care.)
•Platelet count = 100000/mm3, hemoglobin (Hb) = 9 g/dl, absolute neutrophil count (ANC) = 1500/mm3
•Alkaline phosphatase limit = 2.5 x ULN (= 5 x ULN for subjects with liver involvement of their cancer)
•Persistent proteinuria of CTC Grade 3 or higher (> 3.5g / 24 hrs, measured by urine protein: creatinine ration on a random urine sample)
•Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of study treatment, and a negative result must be documented before start of study treatment.
•Women of childbearing potential and men must agree to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method) since signing of the informed consent form until at least 6 months after the last study treatment administration. The investigator or a designated associate is requested to advise the subject how to achieve an adequate birth control.
•Signed informed consent must be obtained before any study specific procedure. Subjects must be able to understand and willing to sign the written informed consent.
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 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 27
•Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter the study.
•Prior systemic anticancer therapy for metastatic CRC. Adjuvant chemotherapy for CRC (Stage I, II, III) is permitted, if the adjuvant therapy ended > 6 months before screening and recurrent disease was documented.
•Prior treatment with antivascular endothelial growth factor (anti-VEGF) agents and any signal transduction inhibitors (STIs)
•Previous or concurrent cancer that is distinct in primary site or histology from CRC within 5 years prior to screening, EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors (Ta [Non invasive tumor], Tis [Carcinoma in situ] and T1 [Tumor invades lamina propria]).
•Pregnant or breastfeeding subjects. Women of childbearing potential not employing adequate contraception or < 2 years from last menstruation.
•Congestive heart failure = New York Heart Association (NYHA) class II
•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 treatment.
•Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
•Uncontrolled hypertension (systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg despite optimal medical management)
•Subjects with phaeochromocytoma
•Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of study treatment
•Ongoing infection > Grade 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
•Known history of human immunodeficiency virus (HIV) infection
•Active or chronic hepatitis B or C infection with a need for antiviral treatment
•Subjects with symptoms, signs, or history of brain metastases (in the case of suspected brain metastases, a cranial CT/MRI is required to exclude brain metastases)
•History of organ allograft
•Subjects with evidence or history of bleeding diathesis.
•Any hemorrhage or bleeding event = CTCAE Grade 3 within 4 weeks of start of study treatment
•Nonhealing wound, ulcer, or bone fracture
•Renal failure requiring hemo-or peritoneal dialysis
•Dehydration = CTCAE Grade 1
•Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results
•Known hypersensitivity to any drug of study treatment, study drug classes, or excipients in the formulation
•Any illness or medical conditions that are unstable or could jeopardize the safety of the subject and his/her compliance in the study
•Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
•Subjects unable to swallow oral medications
•Any malabsorption condition
•Close affiliation with the investigational site (eg
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method