Clinical trial NCT01736878 (phase 2, status: withdrawn)
Conditions: medullary thyroid carcinoma
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: sorafenib
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Reason stopped: 
    study was withdrawn due to unanticipated hassle in patient recruitment.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Inpatient or outpatient ≥ 18 years of age

          -  Histologically confirmed medullary thyroid carcinoma

          -  Recurrent or persistent local disease and/or distant metastases

          -  No more than one prior line of systemic therapy

          -  Best available supportive care to control (endocrine) symptoms

          -  At least one defined lesion in CT or MRI evaluable for Response Evaluation Criteria in
             Solid Tumors (RECIST v1.1), or at least one defined lesion in CT or MRI not evaluable
             by RECIST in combination with elevated tumour markers

          -  Progression within previous 12 months

          -  Hb > 8g/dl, white blood cells (WBC) >3.000 cells/mm³ (ANC > 1.500 cells/mm³),
             platelets > 100.000 cells/mm³, bilirubin < 2mg/dl, alanine aminotransferase (ALT) and
             aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN)

          -  Performance status: WHO ≤ 2; Karnofsky index ≥ 50%

          -  Sufficient renal function (creatinin <1.5 mg/dl and creatinin clearance > 30ml/min)

          -  International normalized ratio (INR) and partial thromboplastin time (PTT) < 1.5 x ULN

          -  No acute infections

          -  Staging studies (MRT or CT and Calcitonin or CEA) completed within four weeks of
             protocol randomisation

          -  Women of childbearing potential with negative serum pregnancy test

          -  Women and men of childbearing potential using adequate contraception

          -  Signed and dated written informed consent

        Exclusion Criteria:

          -  Unresolved toxicity (i.e. neurotoxicity) attributed to any prior therapy higher than
             National Cancer Institute-Common Toxicity Criteria for Adverse Effects (NCI-CTCAE
             version 4) Grade 2 (excluding cases of alopecia)

          -  Patients with history of allergic or hypersensitivity reaction to study drug or
             placebo or their excipients

          -  Current participation in another investigational trial

          -  Patients with significant cardiovascular disease

          -  Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy other than
             beta-blockers or digoxin

          -  Congenital long corrected QT interval (QTc) syndrome, history of drug induced QTc
             prolongation, or QTc interval unmeasurable or more than 450 ms

          -  Abnormal serum electrolytes such as potassium, magnesium and calcium

          -  Uncontrolled hypertension, despite optimal management

          -  Major surgery, open biopsy, or significant traumatic injury within 30 days prior to
             randomization

          -  Non-healing wound, ulcer, or bone fracture

          -  Evidence or history of bleeding diathesis or coagulopathy disorder

          -  Hemorrhage/bleeding event ≥ Grade 3

          -  Thrombotic or embolic events including transient ischemic attacks within the past 6
             months

          -  Subjects with symptomatic brain metastases or Subjects with brain metastases under
             corticosteroid treatment

          -  Pregnant or breast-feeding patients

          -  Patients with uncontrolled infections

          -  Known HIV infection or infection with hepatitis B or C

          -  Immunosuppression

          -  Subjects with seizure disorder requiring medication • Subjects undergoing renal
             dialysis

          -  Substance abuse, medical, psychological or social conditions that may interfere with
             the subject's participation in the study or evaluation of the study results

          -  Any malabsorption condition