Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT00719264
Phase
PHASE2
Status
Completed

Conditions

  • Adenocarcinoma
  • Carcinoma
  • Hypernephroid
  • Nephroid Carcinoma
  • Renal Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RAD001(everolimus) — DRUG
    10 mg qd
  • interferon alfa-2a — DRUG
    dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3
  • bevacizumab — DRUG
    10 mg/kg every 2 weeks

Study Details

To estimate the difference in efficacy and safety of bevacizumab and RAD001 compared to bevacizumab and interferon alfa-2a for first-line treatment of patients with metastatic carcinoma of the kidney.

Key Dates

First listed
Jul 21, 2008
Start date
Nov 12, 2008
Status verified
Feb 2017
Primary completion
Dec 31, 2011
Completion
Apr 15, 2013

Study Design

Enrollment
365 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: bevacizumab, RAD001 (everolimus)
    Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks
  • Active Comparator: bevacizumab, interferon alfa-2a (IFN)
    Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks

Primary Outcome Measure

Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab [ Time Frame: Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date. ]

Locations (9)

FacilityCityStateZIPSite coordinators
Highlands Oncology Group Dept of Highlands Oncology GrpFayettevilleArkansas72703-
City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(3)DuarteCalifornia91010-3000-
University of California at Los Angeles Dept. of Hem/OncologyLos AngelesCalifornia90095-
USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3Los AngelesCalifornia90053-
Karmanos Cancer Institute Dept.of KarmanosCancerInst (5)DetroitMichigan48201-
Nevada Cancer Institute Dept. of Nevada Cancer (3)Las VegasNevada89135-
St. Luke's Hospital and Health Network St. Luke's Cancer NetworkBethlehemPennsylvania--
Las Colinas Hematology Oncology GrapevineIrvingTexas75038-
Seattle Cancer Care Alliance Dept. of SCCASeattleWashington98105-

Find similar trials in Fayetteville, AR

By research site
Highlands Oncology Group Dept of Highlands Oncology Grp· Fayetteville, ARCity of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(3)· Duarte, CAUniversity of California at Los Angeles Dept. of Hem/Oncology· Los Angeles, CAUSC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3· Los Angeles, CAKarmanos Cancer Institute Dept.of KarmanosCancerInst (5)· Detroit, MINevada Cancer Institute Dept. of Nevada Cancer (3)· Las Vegas, NV

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