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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

September 30, 2010
May 27, 2014
March 2011
June 2014   (final data collection date for primary outcome measure)
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 ]
To compare Progression Free Survival (PFS) in TKI258 and Sorafenib Groups (central radiology assessment) [ Time Frame: Until disease progression or discontinuation of treatment due to unacceptable toxicity ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01223027 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To compare Overall Survival (OS) in TKI258 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 TKI258 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 TKI258 concentration in plasma in relation to cardiac safety [ Time Frame: Week 2 Day 5, Week 4 Day 5 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Renal Cell Carcinoma
  • Drug: Dovitinib
    Other Name: TKI258
  • Drug: Sorafenib
  • Experimental: Dovitinib + best supportive care (BSC)
    Intervention: Drug: Dovitinib
  • Active Comparator: Sorafenib + BSC
    Intervention: Drug: Sorafenib
Motzer RJ, Porta C, Vogelzang NJ, Sternberg CN, Szczylik C, Zolnierek J, Kollmannsberger C, Rha SY, Bjarnason GA, Melichar B, De Giorgi U, Grünwald V, Davis ID, Lee JL, Esteban E, Urbanowitz G, Cai C, Squires M, Marker M, Shi MM, Escudier B. Dovitinib versus sorafenib for third-line targeted treatment of patients with metastatic renal cell carcinoma: an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Mar;15(3):286-96. doi: 10.1016/S1470-2045(14)70030-0. Epub 2014 Feb 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
564
June 2014
June 2014   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Colombia,   Czech Republic,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Norway,   Poland,   Saudi Arabia,   Slovakia,   Spain,   Sweden,   Switzerland,   Thailand,   United Kingdom
 
NCT01223027
CTKI258A2302, 2009-015459-25
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP