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

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NCT00494091

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Nanjing, Jiangsu, 210002 China
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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).

NCT00494091
Pfizer
Completed
Study Evaluating The Safety, Efficacy & Pharmacokinetics Of Temsirolimus(CCI-779) In Subjects With Advanced Renal Cell Carcinoma

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[email protected]

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Study Evaluating The Safety, Efficacy & Pharmacokinetics Of Temsirolimus(CCI-779) In Subjects With Advanced Renal Cell Carcinoma
Phase 2, Non Randomized, Open Label Study Of Temsirolimus (CCI-779) In Subjects With Advanced Renal Cell Carcinoma (RCC)
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Renal Cell Carcinoma
  • 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
  • Experimental: A.
    Intervention: Drug: Temsirolimus (CCI-779)
  • Experimental: B.
    Intervention: Drug: Temsirolimus (CCI-779)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
March 2012
May 2011   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China,   Japan,   Korea, Republic of
 
 
NCT00494091
3066K1-2217
B1771002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2013

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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