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Phase 2, Non Randomized, Open Label Study Of Temsirolimus (CCI-779) In Subjects With Advanced Renal Cell Carcinoma (RCC)

Phase 2
20 Years
Not Enrolling
Advanced Renal Cell Carcinoma

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Trial Information

Phase 2, Non Randomized, Open Label Study Of Temsirolimus (CCI-779) In Subjects With Advanced Renal Cell Carcinoma (RCC)

Inclusion Criteria:

- Subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC.
The American Joint Committee on Cancer (AJCC) staging and classification criteria
will be used.

- ECOG performance status of 0-1.

- At least one measurable lesion per RECIST.

- Age greater than or equal to 20 years.

- Japanese, Chinese, or Korean ethnicity.

Exclusion Criteria:

- CNS metastases at screening or history or CNS metastases.

- Prior targeted, chemotherapeutic, cytokine-based, or other investigational agents for
the treatment of RCC within 4 weeks before first dose of test article. Subjects must
have documented objective progressive disease after any prior systemic RCC treatment
and have recovered to grade 1 or lower toxicities from effects of prior systemic
therapy for RCC.

- In past 5 years, other prior malignancy (except basal cell carcinoma, squamous cell
carcinoma of the skin, or cervical carcinoma in situ).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants With Clinical Benefit

Outcome Description:

Clinical benefit: confirmed complete response (CR) or partial response (PR) or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and nontarget lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).

Outcome Time Frame:

Baseline Up to 4 years

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



China: Ministry of Health

Study ID:




Start Date:

February 2007

Completion Date:

March 2012

Related Keywords:

  • Advanced Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell