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

NCT ID: NCT01223027

Last Updated: 2015-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 564 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-06-30

Brief Summary

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

Conditions

Metastatic Renal Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dovitinib + best supportive care (BSC)

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

Group Type: EXPERIMENTAL

Dovitinib

Intervention Type: DRUG

Dovitinib is formulated as an oral gelatin capsule of 100 mg strength and was dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule. Medication labels complied withthe legal requirements of each country and were printed in the local language.

Sorafenib + BSC

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

Group Type: ACTIVE_COMPARATOR

Sorafenib

Intervention Type: DRUG

Sorafenib is formulated as a round, oral, biconvex, red film-coated tablet that contains 200 mg of sorafenib (tosylate). Sorafenib was administered twice daily without food at least 1 hour before or 2 hours after a meal. Sorafenib was supplied according to local practice.

Interventions

Dovitinib

Dovitinib is formulated as an oral gelatin capsule of 100 mg strength and was dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule. Medication labels complied withthe legal requirements of each country and were printed in the local language.

Intervention Type: DRUG

Sorafenib

Sorafenib is formulated as a round, oral, biconvex, red film-coated tablet that contains 200 mg of sorafenib (tosylate). Sorafenib was administered twice daily without food at least 1 hour before or 2 hours after a meal. Sorafenib was supplied according to local practice.

Intervention Type: DRUG

Other Intervention Names

TKI258

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Highlands Oncology Group Dept of Highlands Oncology Grp

Fayetteville, Arkansas, United States

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

Vanderbilt University Medical Center SC

Nashville, Tennessee, United States

Baylor Health Care System/Sammons Cancer Center Dept. of Sammons Cancer (4)

Dallas, Texas, United States

Texas Oncology Texas Onc - Austin

Dallas, Texas, United States

Texas Oncology Texas Oncology - Houston

Dallas, Texas, United States

University of Texas Southwestern Medical Center UTSW

Dallas, Texas, United States

Deke Slayton Cancer Center Deke Slayton Cancer Center (2)

Webster, Texas, United States

Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)

Salt Lake City, Utah, United States

University of Virginia Health Systems Univ Virginia

Charlottesville, Virginia, United States

Rockwood Clinic Spokane Location

Spokane, Washington, United States

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Buenos Aires, Buenos Aires, Argentina

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Rosario, Sante Fe, Argentina

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St Leonards, New South Wales, Australia

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Westmead, New South Wales, Australia

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South Brisbane, Queensland, Australia

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Córdoba, Andalusia, Spain

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Málaga, Andalusia, Spain

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Seville, Andalusia, Spain

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Palma de Mallorca, Balearic Islands, Spain

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Las Palmas de Gran Canarias, Las Palmas de Gran Canaria, Spain

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Benidorm, Valencia, Spain

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Stockholm, , Sweden

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Sundsvall, , Sweden

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London, , United Kingdom

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Countries

United States; Argentina; Australia; Austria; Belgium; Brazil; Canada; Colombia; Czechia; France; Germany; Greece; Hungary; Israel; Italy; Japan; Netherlands; Norway; Poland; Saudi Arabia; Slovakia; South Korea; Spain; Sweden; Switzerland; Thailand; United Kingdom

References

Motzer RJ, Porta C, Vogelzang NJ, Sternberg CN, Szczylik C, Zolnierek J, Kollmannsberger C, Rha SY, Bjarnason GA, Melichar B, De Giorgi U, Grunwald 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.

Reference Type: DERIVED

PMID: 24556040 (View on PubMed)

Other Identifiers

2009-015459-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CTKI258A2302

Identifier Type: -

Identifier Source: org_study_id