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

Novartis

Status and phase: Completed; Phase 3

Conditions: Metastatic Renal Cell Carcinoma

Treatments: Drug: Sorafenib; Drug: Dovitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01223027

CTKI258A2302

2009-015459-25 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 564 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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564 participants in 2 patient groups

Dovitinib + best supportive care (BSC)

Experimental group

Description:

Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib orally on 5 days on/2 days off dosing schedule.

Treatment:

Drug: Dovitinib

Sorafenib + BSC

Active Comparator group

Description:

Patients in the sorafenib control arm received400 mg of sorafenib (2 x 200 mg tablets) orally taken twice daily.

Treatment:

Drug: Sorafenib