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A Study Combining Treatment With Temsirolimus and Sunitinib for Subjects With Advanced Renal Cell Carcinoma

Last updated on February 16, 2019

FOR MORE INFORMATION
Study Location
Baltimore, Maryland, 21231 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
Male
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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1. Histologically confirmed advanced RCC.

2. Up to 2 prior systemic regimens for RCC.

3. Subject must have at least 1 measurable lesion that can be accurately measured in at
least 1 dimension with the longest diameter ³10 mm when measured by spiral computed CT
(5-mm slice thickness contiguous) or ³20 mm when measured by conventional CT (10-mm
slice thickness contiguous) (lesion must be ³ 2 times the size of the slice thickness
per RECIST).

- More criteria apply

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Subjects with known active central nervous system (CNS) malignancy (primary or
metastatic).

2. Prior therapy with sirolimus, temsirolimus or sunitinib.

3. Subjects receiving known strong Cytochrome P450 (CYP)3A4 isoenzyme inhibitors and/or
inducers. Subjects receiving other CYP3A4 isoenzyme inhibitors and/or inducers not
classified as strong inhibitors or inducers are eligible, provided they have been on a
stable regimen for at least 4 weeks before screening.

- More criteria apply

Inclusion Criteria for Expanded Cohort Phase

1. Subjects with histologically confirmed advanced RCC regardless of nephrectomy status
who have received no prior systemic therapies for their disease.

2. Subjects with histologically confirmed advanced RCC regardless of nephrectomy status
who have a least 4 weeks since prior treatment with palliative radiation therapy,
and/or surgery and resolution of all toxic effects of prior therapy to NCI CTCAE
(version 3.0) grade £1.

3. Subjects must have at least 1 measurable lesion that can be accurately measured in at
least 1 dimension with the longest diameter ³10 mm when measured by spiral CT (5-mm
slice thickness contiguous) or ³20 mm when measured by conventional CT (10-mm slice
thickness contiguous) (lesion must be ³2 times the size of the slice thickness per
RECIST).

- More Criteria apply

Exclusion Criteria for the Expanded Cohort Phase

1. Subjects with a history of a CNS malignancy or metastatic disease to the CNS and
subjects with a known, active CNS malignancy (primary or metastatic).

2. Prior anti-vascular endothelial growth factor (anti-VEGF) therapies (with either
monoclonal antibodies and/or tyrosine kinase inhibitors [TKIs]) and/or mTOR
inhibitors.

3. Subjects receiving known strong CYP3A4 isoenzyme inhibitors and/or inducers. Subjects
taking other CYP3A4 isoenzyme inhibitors and/or inducers not classified as strong
inhibitors or inducers are eligible, provided they have been on a stable regimen for
at least 4 weeks before screening.

- More Criteria apply

NCT00417677
Pfizer
Terminated
A Study Combining Treatment With Temsirolimus and Sunitinib for Subjects With Advanced Renal Cell Carcinoma

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Pfizer Clinical Trials Contact Center

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[email protected]

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FOR MORE INFORMATION

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

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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