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Trial record 1 of 1 for:    3066K1-2217
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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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ClinicalTrials.gov Identifier: NCT00494091
Recruitment Status : Completed
First Posted : June 29, 2007
Results First Posted : July 9, 2012
Last Update Posted : March 21, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Renal Cell Carcinoma Drug: Temsirolimus (CCI-779) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2, Non Randomized, Open Label Study Of Temsirolimus (CCI-779) In Subjects With Advanced Renal Cell Carcinoma (RCC)
Study Start Date : February 2007
Actual Primary Completion Date : May 2011
Actual Study Completion Date : March 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: A. Drug: Temsirolimus (CCI-779)
20 mg/m2 IV TEMSR weekly (Japan, n=6)
Other Name: Torisel
Experimental: B. Drug: Temsirolimus (CCI-779)
25 mg IV TEMSR weekly (all other pts)
Other Name: Torisel


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Clinical Benefit [ Time Frame: Baseline Up to 4 years ]
    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).


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: Baseline Up to 4 years ]
    Median time from the date of enrollment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.

  2. Percentage of Participants With Objective Response [ Time Frame: Baseline Up to 4 years ]
    Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria In Solid Tumors (RECIST). CR is disappearance of all target lesions. PR shows at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  3. Duration of Response [ Time Frame: Baseline Up to 4 years ]
    Time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented, taking as reference for PD the smallest sum longest diameters (LD) recorded since enrollment.

  4. Time to Treatment Failure (TTF) [ Time Frame: Baseline Up to 4 years ]
    TTF is defined as the time from the date of enrollment to the date of the first documentation of PD, the date of treatment discontinuation except completion of treatment, or date of death due to cancer.

  5. Overall Survival (OS) [ Time Frame: Baseline Until Death (Up to 4 years) ]
    Time in months from the date of enrollment to date of death due to any cause. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).


Other Outcome Measures:
  1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0 hours (pre-dose), 0.5 hours, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment ]
    Sirolimus is a major metabolite of temsirolimus. As per planned analysis, only participants in "Temsirolimus 20 mg/m^2" treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis.

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment ]
    Sirolimus is a major metabolite of temsirolimus. As per planned analysis, only participants in "Temsirolimus 20 mg/m^2" treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis.

  3. Plasma Decay Half-Life (t1/2) [ Time Frame: 0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Sirolimus is the major metabolite of temsirolimus. As per planned analysis, only participants in "Temsirolimus 20 mg/m^2" treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis.

  4. Area Under the Concentration-Time Curve (AUC) [ Time Frame: 0 hours (pre-dose), 0.5 hours, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Sirolimus is the major metabolite of temsirolimus. As per planned analysis, only participants in "Temsirolimus 20 mg/m^2" treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis.

  5. Clearance (CLss) of Temsirolimus [ Time Frame: 0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment ]
    Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of temsirolimus (R0/Css). As per planned analysis, only participants in "Temsirolimus 20 mg/m^2" treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis.

  6. Volume of Distribution at Steady State (Vss) of Temsirolimus [ Time Frame: 0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment ]
    Vss is an estimate of the volume of distribution at steady state. It is used to predict the plasma concentrations following multiple dosing to a steady-state or pseudo-equilibrium. Vss is proportional to the amount of drug in the body versus the plasma concentration of the drug at steady state. As per planned analysis, only participants in "Temsirolimus 20 mg/m^2" treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494091


Locations
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China, Jiangsu
Pfizer Investigational Site
Nanjing, Jiangsu, China, 210002
China
Pfizer Investigational Site
Beijing, China, 100021
Pfizer Investigational Site
Beijing, China, 100036
Pfizer Investigational Site
Beijing, China, 100730
Pfizer Investigational Site
Shanghai, China, 200032
Pfizer Investigational Site
Shanghai, China, 200127
Japan
Pfizer Investigational Site
Chiba, Japan
Pfizer Investigational Site
Fukuoka, Japan
Pfizer Investigational Site
Gunma, Japan
Pfizer Investigational Site
Hokkaido, Japan
Pfizer Investigational Site
Ibaraki, Japan
Pfizer Investigational Site
Kagawa, Japan
Pfizer Investigational Site
Kagoshima, Japan
Pfizer Investigational Site
Kyoto, Japan
Pfizer Investigational Site
Nara, Japan
Pfizer Investigational Site
Okayama, Japan
Pfizer Investigational Site
Osaka, Japan
Pfizer Investigational Site
Shizuoka, Japan
Pfizer Investigational Site
Tokyo, Japan
Pfizer Investigational Site
Yamagata, Japan
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 120-752
Pfizer Investigational Site
Seoul, Korea, Republic of, 135 710
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00494091    
Other Study ID Numbers: 3066K1-2217
B1771002
First Posted: June 29, 2007    Key Record Dates
Results First Posted: July 9, 2012
Last Update Posted: March 21, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
 Male Urogenital Diseases
Sirolimus
Temsirolimus
MTOR Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents