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

NCT00417677

Last updated date
Study Location
Baltimore, Maryland, 21231, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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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

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

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

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Combining Treatment With Temsirolimus and Sunitinib for Subjects With Advanced Renal Cell Carcinoma
Official Title  ICMJE A Phase I/II Study of Temsirolimus and Sunitinib in Subjects With Advanced Renal Cell Carcinoma
Brief Summary 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
Detailed Description 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE Drug: Combination of Temsirolimus and Sunitinib
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: January 3, 2007)
124
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00417677
Other Study ID Numbers  ICMJE 3066K1-402
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP