Study Evaluating The Safety, Efficacy & Pharmacokinetics Of Temsirolimus(CCI-779) In Subjects With Advanced Renal Cell Carcinoma

NCT00494091

Last updated date
Study Location
Pfizer Investigational Site
Nanjing, Jiangsu, 210002, China
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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


- 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).

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating The Safety, Efficacy & Pharmacokinetics Of Temsirolimus(CCI-779) In Subjects With Advanced Renal Cell Carcinoma
Official Title  ICMJE Phase 2, Non Randomized, Open Label Study Of Temsirolimus (CCI-779) In Subjects With Advanced Renal Cell Carcinoma (RCC)
Brief Summary This is a study to evaluate the safety, efficacy and pharmacokinetics of temsirolimus in Asian patients with advanced renal cell carcinoma. The trial is only being conducted in Japan, Korea, and China.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Renal Cell Carcinoma
Intervention  ICMJE
  • Drug: Temsirolimus (CCI-779)
    20 mg/m2 IV TEMSR weekly (Japan, n=6)
    Other Name: Torisel
  • Drug: Temsirolimus (CCI-779)
    25 mg IV TEMSR weekly (all other pts)
    Other Name: Torisel
Study Arms  ICMJE
  • Experimental: A.
    Intervention: Drug: Temsirolimus (CCI-779)
  • Experimental: B.
    Intervention: Drug: Temsirolimus (CCI-779)
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 Completed
Actual Enrollment  ICMJE
 (submitted: April 14, 2011)
82
Original Enrollment  ICMJE
 (submitted: June 28, 2007)
80
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 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 China,   Japan,   Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00494091
Other Study ID Numbers  ICMJE 3066K1-2217
B1771002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2013

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