Clinical trial NCT01584830 (phase 3, status: completed)
Conditions: colorectal neoplasms
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: regorafenib (bay73-4506), placebo
SMILES: CNC(=O)C1=CC(OC2=CC(F)=C(NC(=O)NC3=CC=C(Cl)C(=C3)C(F)(F)F)C=C2)=CC=N1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological documentation of adenocarcinoma of the colon or rectum.
             All other histological types are excluded.

          -  Subjects with metastatic colorectal cancer(CRC) (Stage IV).

          -  Subjects must have failed at least two lines of prior treatment.

          -  Progression during or within 3 months following the last administration of approved
             standard therapies which must include a fluoropyrimidine, oxaliplatin and irinotecan.

               -  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               -  Subjects who have withdrawn from standard treatment due to unacceptable toxicity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.

               -  Subjects may have received prior treatment with Avastin (bevacizumab) and/or
                  Erbitux (cetuximab)/Vectibix (panitumumab) (if KRAS WT)

          -  Metastatic CRC subjects 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.

          -  Adequate bone marrow, liver and renal function as assessed by the laboratory required
             by protocol.

        Exclusion Criteria:

          -  Prior treatment with Regorafenib.

          -  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.

          -  Cardiological disease including Congestive heart failure, Unstable angina, Myocardial
             infarction, Cardiac arrhythmias requiring anti-arrhythmic therapy.

          -  Uncontrolled hypertension. (Systolic blood pressure 150 mmHg or diastolic pressure 90
             mmHg despite optimal medical management).

          -  Subjects with phaeochromocytoma.

          -  Pleural effusion or ascites that causes respiratory compromise.

          -  Arterial or venous thrombotic or embolic events.

          -  Any history of or currently known brain metastases.

          -  Interstitial lung disease with ongoing signs and symptoms at the time of informed
             consent.

          -  Systemic anticancer therapy including cytotoxic therapy, signal transduction
             inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 week.