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

Last updated on December 15, 2017

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.
Show details

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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A Study Combining Treatment With Temsirolimus and Sunitinib for Subjects With Advanced Renal Cell Carcinoma
A Phase I/II Study of Temsirolimus and Sunitinib in Subjects With Advanced Renal Cell Carcinoma
This study is being conducted to determine the Maximum Tolerated Dose (MTD) and efficacy of the combined treatment of Temsirolimus and Sunitinib for the treatment of Advanced Kidney Cancer
A study to determine the safety, tolerability, and maximum tolerated dose (MTD) of the combination of temsirolimus and sunitinib in subjects with advanced Renal Cell Carcinoma (RCC) (dose escalation phase). Once the MTD is determined, this study will also evaluate the efficacy of this combination by determining progression free survivial (PFS) at 12 months in subjects with advanced RCC (expanded cohort phase).
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Renal Cell Carcinoma
Drug: Combination of Temsirolimus and Sunitinib
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
124
May 2007
Not Provided

Inclusion Criteria for Dose Escalation Phase

  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 for Dose Escalation Phase

  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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00417677
3066K1-402
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
October 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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