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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01223027
First received: September 30, 2010
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Metastatic Renal Cell Carcinoma
Drug: Dovitinib
Drug: Sorafenib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To compare Progression Free Survival (PFS) in Dovitinib and Sorafenib Groups (central radiology assessment) [ Time Frame: Until disease progression or discontinuation of treatment due to unacceptable toxicity ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare Overall Survival (OS) in Dovitinib and Sorafenib Groups [ Time Frame: until at least 386 deaths are documented in the clinical database. ] [ Designated as safety issue: No ]
  • To compare Progression Free Survival (PFS) in Dovitinib and Sorafenib Groups (investigator assessed) [ Time Frame: Until disease progression or discontinuation of treatment due to unacceptable toxicity ] [ Designated as safety issue: No ]
  • Overall response rate (ORR) by central and local radiology [ Time Frame: Until disease progression or discontinuation of treatment due to unacceptable toxicity ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs), serious adverse events (SAEs), changes from baseline in vital signs, ECGs and laboratory results (hematology, blood chemistry, urinalysis, thyroid function tests, lipid profile, cardiac enzimes and coagulation tests). [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • To assess patient-reported outcomes (PROs), including disease-related symptoms using the FKSI-DRS questionnaire and Quality of Life using the EORTC QLQ-C30 questionnaire [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • To assess the Dovitinib concentration in plasma in relation to cardiac safety [ Time Frame: Week 2 Day 5, Week 4 Day 5 ] [ Designated as safety issue: No ]

Enrollment: 564
Study Start Date: March 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dovitinib + best supportive care (BSC) Drug: Dovitinib
Other Name: TKI258
Active Comparator: Sorafenib + BSC Drug: Sorafenib

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01223027

  Show 198 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01223027     History of Changes
Other Study ID Numbers: CTKI258A2302, 2009-015459-25
Study First Received: September 30, 2010
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Israel: Ministry of Health
Saudi Arabia: Ministry of Health
Brazil: Ministry of Health
Columbia: National Institutes of Health
Argentina: Ministry of Health
Thailand: Food and Drug Administration (KFDA)
south Korea:

Keywords provided by Novartis:
Dovitinib
TKI
Renal cell cancer
RCC
mRCC

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014