Sequential Two-agent Assessment in Renal Cell Carcinoma Therapy: The START Trial

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01217931
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Pazopanib — DRUG
    800 mg by mouth once daily for 28 days. A cycle consists of 4 weeks.
  • Bevacizumab — DRUG
    10 mg/kg by vein every two weeks. A cycle consists of 4 weeks.
  • Everolimus — DRUG
    10 mg by mouth once daily. A cycle consists of 4 weeks.

Study Details

The goal of this clinical research study is to compare 6 different 2-drug "sequences" of everolimus, bevacizumab, or pazopanib to learn how they may affect metastatic kidney cancer. For the 2-drug sequence, participants will receive 1 of these drugs and may start taking another of these drugs after that. Researchers will also study the safety of these 2-drug sequences.

Key Dates

First listed
Oct 8, 2010
Start date
Jan 19, 2011
Status verified
Jan 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
180 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Pazopanib + possible Bevacizumab
  • Experimental: Group 2
    Pazopanib + possible Everolimus
  • Experimental: Group 3
    Everolimus + possible Bevacizumab
  • Experimental: Group 4
    Everolimus + possible Pazopanib
  • Experimental: Group 5
    Bevacizumab + possible Pazopanib
  • Experimental: Group 6
    Bevacizumab + possible Everolimus

Primary Outcome Measure

Time to Overall Treatment Failure [ Time Frame: 4 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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