A randomized, double-blind, placebo-controlled phase III study of regorafenib plus BSC versus placebo plus BSC in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy - CORRECT

Bayer HealthCare AG0 个研究点目标入组 690 人开始时间: 2010年3月10日最近更新: 2014年4月14日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Bayer HealthCare AG
入组人数: 690

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Signed informed consent obtained before any study specific procedures. Patients must be able to understand and willing to sign a written informed consent.
•Male or female patients =18 years of age.
•Histological or cytological documentation of adenocarcinoma of the colon or rectum.
•All other histological types are excluded.
•Patients 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 or panitumumab (if KRAS WT). Patients treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy. Patients who progress more than 6 months after completion of oxaliplatin containing adjuvant treatment must be retreated with oxaliplatin-based therapy to be eligible. Patients who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed into the study. Patients with an unknown KRAS status at screening must have received prior anti-EGFR treatment.
•Metastatic CRC patients must have measurable or non measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST criteria, version 1.1).
•Eastern Cooperative Oncology Group (ECOG) Performance Status of = 1.
•Life expectancy of at least 3 months.
•Women of childbearing potential and men must agree to use adequate contraception since signing of the informed consent form until at least 3 months after the last study drug administration. The investigator or a designated associate is requested to advise the patient how to achieve an adequate birth control. Adequate contraception is defined in the study as any medically recommend method (or combination of methods) as per standard of care.
•Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
•o Total bilirubin =1.5 x the upper limit of normal (ULN).
•o Alanine transaminase (ALT) and aspartate aminotransferase (AST) = 2.5 x ULN
•(=5 x ULN for patients with liver involvement of their cancer).
•o Amylase and lipase = 1.5 x the ULN
•o Serum creatinine = 1.5 x the ULN.
•o Glomerular filtration rate (GFR) = 30 ml/min/1.73 m2 according to the MDRD (Modified diet in renal disease) abbreviated formula
•o INR/PTT = 1.5 x ULN (Patients who are being therapeutically anti-coagulated 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 pre-dose as defined by the local standard of care.)
•o Platelet count = 100000 /mm3, Hemoglobin (Hb) = 9 g/dl, Absolute neutrophil count (ANC) = 1500/mm3
•o Alkaline phosphatase limit = 2.5 x ULN (=5 x ULN for patients with liver involvement of their cancer)
•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 475
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 285

排除标准

•Prior treatment with regorafenib.
•Previous assignment to treatment during this study. Patients permanently withdrawn from study treatment participation will not be allowed to re-enter the study.
•Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization 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)].
•Extended field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks prior to randomization. Patients must have recovered from all therapy-related toxicities. The site of previous radiotherapy should have evidence of progressive disease if this is the only site of disease.
•Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication.
•Pregnant or breast-feeding patients. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of treatment.
•Congestive heart failure = 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 medication.
•Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
•Uncontrolled hypertension. (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
•Patients with phaeochromocytoma.
•Pleural effusion or ascites that causes respiratory compromise (= CTC Grade 2 dyspnea).
•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 medication.
•Ongoing infection > grade 2 NCI-CTC version 3.0.
•Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy.
•Patients with seizure disorder requiring medication.
•Any history of or currently known brain metastases.
•History of organ allograft
•Patients with evidence or history of any bleeding diasthesis, irrespective of severity.
•Any hemorrhage or bleeding event = 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 NCI-CTC version 3.0 grade = 1.
•Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
•Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation
•Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.
•Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
•Patients unable to swallow oral medications
•Persistent proteinuria of CTC Grade 3 or higher (> 3.5 g/24 hrs, measured by urine protein:creatinine ratio on a random urine sample).
•Any malabsorption condition
•Close affiliation with the investigational site; e.g. a close relative of the investigator, depen

研究者

发起方

Bayer HealthCare AG

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