Trial Search Results

Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Novartis Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: Dovitinib
  • Drug: Sorafenib

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting