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

Completed · Phase 3

Conditions studied: Metastatic Renal Cell Carcinoma

In brief

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

Key facts

Study ID

NCT01223027

Run by

Novartis Pharmaceuticals

People needed

564

Starts

2011-03-01

Expected to finish

2014-06-01

Last updated by the study team

2015-12-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (5) — La Jolla, California, United States
• Cedars Sinai Medical Center Cedars Sinai Medical Ctr. (SC) — Los Angeles, California, United States
• University of California at Los Angeles UCLA (4) — Los Angeles, California, United States
• Stanford University Medical Center Cancer Clinical Trials Office — Stanford, California, United States
• Rocky Mountain Cancer Centers RMCC — Greenwood Village, Colorado, United States
• Florida Cancer Specialists DeptofFloridaCancerSpecialists — Fort Myers, Florida, United States
• University Cancer & Blood Center, LLC — Athens, Georgia, United States
• Straub Clinic & Hospital Straub — Honolulu, Hawaii, United States
• Moanalua Medical Center. Attn: Oncology Dept — Honolulu, Hawaii, United States
• University of Kansas Cancer Center Univ of KS — Kansas City, Kansas, United States
• University of Maryland Medical Center UMMC — Baltimore, Maryland, United States
• Karmanos Cancer Institute Dept.of KarmanosCancerInst (5) — Detroit, Michigan, United States
• University of Minnesota Medical Center - Fairview Univ of MN — Minneapolis, Minnesota, United States
• Comprehensive Cancer Centers of Nevada CCC of Nevada (1) — Las Vegas, Nevada, United States
• CINJ at Cooper University Hospital Cooper — Voorhees Township, New Jersey, United States
• Memorial Sloan Kettering Cancer Center Dept. of MSKCC — New York, New York, United States
• SUNY - Upstate Medical University Div. of Hematology-Oncology — Syracuse, New York, United States
• New York Oncology Hematology, P.C. Dept. of New York Oncology. PC — Troy, New York, United States
• Willamette Valley Clinical Studies Williamette Valley Cancer — Eugene, Oregon, United States
• St. Luke's Hospital and Health Network St Luke's — Bethlehem, Pennsylvania, United States
• Medical University of South Carolina -Hollings Cancer Center Med Univ SC — Charleston, South Carolina, United States
• Cancer Centers of the Carolinas CC of C -Eastside — Greenville, South Carolina, United States
• Sarah Cannon Research Institute SC - 3 — Chattanooga, Tennessee, United States
• The West Clinic — Memphis, Tennessee, United States
• Highlands Oncology Group Dept of Highlands Oncology Grp — Fayetteville, Arkansas, United States

Full record on ClinicalTrials.gov

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