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An Open-label, Randomized, Multi-center, Phase III Study to Compare the Safety and Efficacy of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma After Failure of Anti-angiogenic (VEGF-targeted and mTOR Inhibitor) Therapies


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Metastatic Renal Cell Carcinoma

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Trial Information

An Open-label, Randomized, Multi-center, Phase III Study to Compare the Safety and Efficacy of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma After Failure of Anti-angiogenic (VEGF-targeted and mTOR Inhibitor) Therapies


Inclusion Criteria:



1. Age ≥ 18 years old

2. Patients with metastatic renal cell carcinoma (mRCC) with histological or
cytological confirmation of clear cell carcinoma or a component of clear cell

3. 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)

4. Prior cytokines therapy and prior vaccines in the adjuvant setting is permitted.

5. Patients must have had disease progression on or within 6 months of stopping the last
therapy.

6. 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).

7. Karnofsky performance status ≥ 70%

8. 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:

1. Patients who have previously received sorafenib therapy in the neoadjuvant, adjuvant
or metastatic setting.

2. Patients who have previously received Dovitinib or brivanib in the neoadjuvant,
adjuvant or metastatic setting.

3. Patients with brain metastases. Radiological imaging (e.g. CT or MRI scan) of the
brain is required at screening/baseline

4. 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

5. 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

6. 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

7. 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

8. Patients with a history of pulmonary embolism (PE), or untreated deep venous
thrombosis (DVT) within the past 6 months

9. Patients with concurrent severe and/or uncontrolled medical conditions which could
compromise participation in the study

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare Progression Free Survival (PFS) in Dovitinib and Sorafenib Groups (central radiology assessment)

Outcome Time Frame:

Until disease progression or discontinuation of treatment due to unacceptable toxicity

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CTKI258A2302

NCT ID:

NCT01223027

Start Date:

March 2011

Completion Date:

May 2013

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • Dovitinib
  • TKI
  • Renal cell cancer
  • RCC
  • mRCC
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

The West ClinicMemphis, Tennessee  38120
Kaiser Permanente HawaiiHonolulu, Hawaii  96819
Northeast Georgia Cancer CareAthens, Georgia  30607
Cancer Centers of the Carolinas CC of C -EastsideGreenville, South Carolina  29605
Rocky Mountain Cancer Centers RMCC - Denver-MidtownGreenwood Village, Colorado  
Highlands Oncology Group Dept of Highlands Oncology GrpFayetteville, Arkansas  72703
New York Oncology Hematology, P.C. Dept. of New York Oncology. PCTroy, New York  12180
Cedars Sinai Medical Center Cedars Sinai Medical Ctr. (SC)Los Angeles, California  90048
Comprehensive Cancer Centers of Nevada CCC of Nevada (1)Las Vegas, Nevada  89109
Florida Cancer Specialists DeptofFloridaCancerSpecialistsFort Myers, Florida  33901
St. Luke's Hospital and Health Network St Luke'sBethlehem, Pennsylvania  
University of California San Diego Dept of Moores Cancer Ctr (5)La Jolla, California  92093-0658
Straub Clinic & Hospital StraubHonolulu, Hawaii  96813
University of Kansas Cancer Center Univ of KSKansas City, Kansas  66160
University of Maryland Medical Center UMMCBaltimore, Maryland  21201
Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (5)Detroit, Michigan  48201
University of Minnesota Medical Center - Fairview Univ of MNMinneapolis, Minnesota  55455
CINJ at Cooper University Hospital CooperVoorhees, New Jersey  08043
Memorial Sloan Kettering Cancer Center Dept. of MSKCCNew York, New York  10021
SUNY - Upstate Medical University Div. of Hematology-OncologySyracuse, New York  13210
Willamette Valley Clinical Studies Williamette Valley CancerEugene, Oregon  97404
Medical University of South Carolina Med Univ SCCharleston, South Carolina  29425
Vanderbilt University Medical Center SCNashville, Tennessee  37232
Texas Oncology, P.A. Texas Oncology - HoustonDallas, Texas  75251
University of Texas Southwestern Medical Center UTSWDallas, Texas  75390-9034
Texas Oncology, P.A. Texas Onc - AustinDallas, Texas  75251
Deke Slayton Cancer Center c/o Study CoordinatorWebster, Texas  77598
Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)Salt Lake City, Utah  84103
University of Virginia Health Systems Univ VirginiaCharlottesville, Virginia  22908-0334
Rockwood Clinic Spokane LocationSpokane, Washington  99202
University of California at Los Angeles UCLA (4)Los Angeles, California  90095
Stanford University Medical Center Cancer Clinical Trials OfficeStanford, California  94304
Sarah Cannon Research Institute SC - 3Chattanooga, Tennessee  37404
Baylor College of Medicine Dept. of Sammons Cancer (4)Dallas, Texas  75246