Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma
Condition: Metastatic Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Dovitinib; Sorafenib
Intervention description: Dovitinib is formulated as an oral gelatin capsule of 100 mg strength and was dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule. Medication labels complied withthe legal requirements of each country and were printed in the local language.; Sorafenib is formulated as a round, oral, biconvex, red film-coated tablet that contains 200 mg of sorafenib (tosylate). Sorafenib was administered twice daily without food at least 1 hour before or 2 hours after a meal. Sorafenib was supplied according to local practice.
Intervention MeSH terms: Sorafenib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 564.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dovitinib; TKI; Renal cell cancer; RCC; mRCC

Summary:

      This study will evaluate the safety and efficacy of Dovitinib versus sorafenib in patients
      with metastatic renal cell cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with metastatic renal cell carcinoma (mRCC) with histological or cytological
             confirmation of clear cell carcinoma or a component of clear cell

          -  Patients must have received one and only one prior VEGF-targeted therapy and one and
             only one prior mTOR inhibitor therapy in the metastatic setting. One VEGF targeted
             therapy (e.g. sunitinib, or pazopanib, or axitinib, or tivozanib or bevacizumab) and
             one prior mTOR inhibitor therapy (everolimus, or temsirolimus or ridaforolimus)

          -  Prior cytokines therapy and prior vaccines in the adjuvant setting is permitted.

          -  Patients must have had disease progression on or within 6 months of stopping the last
             therapy.

          -  Patients must have at least one measurable lesion at baseline (by RECIST Criteria
             Guidelines v1.1) assessed by Computer Tomography (CT) Scan or Magnetic Resonance
             Imaging (MRI).

          -  Karnofsky performance status ≥ 70%

          -  Patients must have the following laboratory values:

               -  Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L

               -  Platelets ≥ 100 x 109/L

               -  Hemoglobin (Hgb) > 9 g/dL

               -  Serum total bilirubin: ≤ 1.5 x ULN

               -  ALT and AST ≤ 3.0 x ULN (Patients with known liver metastases: AST and ALT ≤ 5.0
                  x ULN)

               -  Serum creatinine ≤ 1.5 x ULN

        Exclusion Criteria:

          -  Patients who have previously received sorafenib therapy in the neoadjuvant, adjuvant
             or metastatic setting.

          -  Patients who have previously received Dovitinib or brivanib in the neoadjuvant,
             adjuvant or metastatic setting.

          -  Patients with brain metastases. Radiological imaging (e.g. CT or MRI scan) of the
             brain is required at screening/baseline

          -  Patients with another primary malignancy within 3 years prior to starting study
             treatment, with the exception of adequately treated basal cell carcinoma, squamous
             cell carcinoma or non-melanomatous skin cancer, or in-situ carcinoma of the uterine
             cervix

          -  Patients who have received the last administration of an anticancer targeted small
             molecule therapy ≤ 2 weeks prior to starting study treatment (e.g. sunitinib,
             pazopanib, axitinib, everolimus, temsirolimus), or who have not recovered from the
             side effects of such therapy

          -  Patients who have received the last administration of nitrosurea or mitomycin-C ≤ 6
             weeks prior to starting study treatment, or who have not recovered from the side
             effects of such therapy

          -  Patients who have undergone major surgery (e.g., intra-thoracic, intra-abdominal or
             intra-pelvic) ≤ 4 weeks prior to starting study treatment or who have not recovered
             from side effects of such therapy

          -  Patients with a history of pulmonary embolism (PE), or untreated deep venous
             thrombosis (DVT) within the past 6 months

          -  Patients with concurrent severe and/or uncontrolled medical conditions which could
             compromise participation in the study

        Other protocol-defined inclusion/exclusion criteria may apply