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Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In Subjects With Advanced Renal Cell Carcinoma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Renal Cell Carcinoma

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Trial Information

Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In Subjects With Advanced Renal Cell Carcinoma


Inclusion Criteria:



- Histologically and/or cytologically confirmed to have advanced renal cell carcinoma
(RCC)

- Majority component of conventional clear-cell type is mandatory

- At least 1 measurable lesion (per RECIST)

Exclusion Criteria:

- Prior systemic treatment for RCC

- Evidence of current or prior central nervous system (CNS) metastases

- Cardiovascular disease

- Pregnant or nursing women

- Additional criteria applies

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS): Independent-Assessment

Outcome Description:

PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.

Outcome Time Frame:

Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3066K1-3311

NCT ID:

NCT00631371

Start Date:

April 2008

Completion Date:

December 2013

Related Keywords:

  • Renal Cell Carcinoma
  • temsirolimus
  • renal cell carcinoma
  • kidney cancer
  • urogenital cancer
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteNorth Little Rock, Arkansas  72117
Pfizer Investigational SiteBartlesville, Oklahoma  74006
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteOlive Branch, Mississippi  38654