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BAY 1212   |   12-719
An open-label phase IIIB study of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy

Main Campus

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  1. To provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed after all approved standard therapies
  2. To assess the safety of regorafenib
  3. To estimate progression free survival (PFS)

Inclusion Criteria
  • Inclusion criteria must be met at the time of screening unless otherwise specified.
    1. Signed informed consent (IC) obtained before any study specific procedures. Subjects must be able to understand and willing to sign a written informed consent.
    2. Male or female ≥ 18 years of age.
    3. Life expectancy of at least 3 months
    4. Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
    5. Subjects with metastatic colorectal cancer (Stage IV).
    6. 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)
      • Subjects treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy
      • Subjects who progress more than 6 months after completion of oxaliplatin containing adjuvant treatment must be retreated with oxaliplatin-based therapy to be eligible. Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to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
    7. ECOG Performance Status of ≤ 1
    8. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements:
        • Total bilirubin ≤ 1.5 x the upper limit of normal (ULN). Documented Gilbert syndrome is allowed if total bilirubin is mildly elevated (< 6 mg/dL)
        • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer).
        • Alkaline phosphatase limit ≤ 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
        • International normalized ratio (INR)/ Partial thromboplastin time (PTT) ≤ 1.5 x ULN. (Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters 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.
        • Platelet count ≥ 100,000/mm^3, hemoglobin (Hb) ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1500/mm^3. Blood transfusion to meet the inclusion criteria will not be allowed.
      • Women of childbearing potential and men must agree to use adequate contraception since signing of the IC form until at least 3 months after the last study drug administration. The investigator or a designated associate is requested to advise the subject on how to achieve adequate birth control. Adequate contraception is defined in the study as any medically recommend method (or combination of methods) as per standard of care.

    Exclusion Criteria
    1. Prior treatment with regorafenib.
    2. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug
    3. Pregnant or breast-feeding subjects. 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 study drug.
    4. Congestive heart failure ≥ New York Heart Association (NYHA) class 2.
    5. Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months).
    6. Myocardial infarction less than 6 months before start of study drug.
    7. Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
    8. Uncontrolled hypertension. (Systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
    9. Pleural effusion or ascites that causes respiratory compromise (≥ CTCAE Grade 2 dyspnea).
    10. Ongoing infection > Grade 2 CTCAE v. 4.0.
    11. Known history of human immunodeficiency virus (HIV) infection.
    12. Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy.
    13. Subjects with seizure disorder requiring medication.
    14. History of organ allograft.
    15. Subjects with evidence or history of any bleeding diathesis, irrespective of severity.
    16. Any hemorrhage or bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to the start of study medication.
    17. Non-healing wound, ulcer, or bone fracture.
    18. Renal failure requiring hemo-or peritoneal dialysis.
    19. Dehydration CTCAE v. 4.0 Grade ≥ 1
    20. Substance abuse, medical, psychological or social conditions that may interfere with the subjects participation in the study or evaluation of the study results.
    21. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
    22. Any illness or medical conditions that are unstable or could jeopardize the safety of the subject and his/her compliance in the study.
    23. Interstitial lung disease with ongoing signs and symptoms
    24. Persistent proteinuria of CTCAE Grade 3 (gt; 3.5 g/24 hours).
    25. Subjects unable to swallow oral medications.
    26. Any malabsorption condition.
    27. 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.
    28. Concomitant participation or participation within the last 30 days in another clinical trial
    29. 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.

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