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Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Duarte, California, 91010 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Histologically confirmed diagnosis of mRCC (regardless of histology or nephrectomy
status) with well-documented Radiological PD by RECIST criteria or clinical PD as
judged by the investigator while receiving first-line sunitinib therapy. Subjects must
have at least 1 cycle of sunitinib therapy (minimum of four weeks continuously).

- At time of randomization, at least 2 weeks since prior treatment with sunitinib,
palliative radiation therapy, and/or surgery.

- At time of randomization, there must be at least 1 measurable lesion per RECIST.
Lesions that have been previously irradiated or embolized cannot be selected as target
lesions.

- More criteria apply

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Metastatic CNS from RCC.

- Subjects who discontinued Sutent therapy due specifically to intolerance.

- Prior systemic therapy for mRCC other than sunitinib.

- Active ketonuria, secondary to poorly controlled diabetes mellitus

- More criteria apply

NCT00474786
Pfizer
Completed
Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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