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

Primary Purpose

Advanced Renal Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Temsirolimus (CCI-779)
Temsirolimus (CCI-779)
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Renal Cell Carcinoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A.

B.

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Clinical Benefit
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

Progression-free Survival (PFS)
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.
Percentage of Participants With Objective Response
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.
Duration of Response
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.
Time to Treatment Failure (TTF)
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.
Overall Survival (OS)
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).

Full Information

First Posted
June 28, 2007
Last Updated
March 15, 2013
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00494091
Brief Title
Study Evaluating The Safety, Efficacy & Pharmacokinetics Of Temsirolimus(CCI-779) In Subjects With Advanced Renal Cell Carcinoma
Official Title
Phase 2, Non Randomized, Open Label Study Of Temsirolimus (CCI-779) In Subjects With Advanced Renal Cell Carcinoma (RCC)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Renal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A.
Arm Type
Experimental
Arm Title
B.
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Temsirolimus (CCI-779)
Other Intervention Name(s)
Torisel
Intervention Description
20 mg/m2 IV TEMSR weekly (Japan, n=6)
Intervention Type
Drug
Intervention Name(s)
Temsirolimus (CCI-779)
Other Intervention Name(s)
Torisel
Intervention Description
25 mg IV TEMSR weekly (all other pts)
Primary Outcome Measure Information:
Title
Percentage of Participants With Clinical Benefit
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).
Time Frame
Baseline Up to 4 years
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
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.
Time Frame
Baseline Up to 4 years
Title
Percentage of Participants With Objective Response
Description
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.
Time Frame
Baseline Up to 4 years
Title
Duration of Response
Description
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.
Time Frame
Baseline Up to 4 years
Title
Time to Treatment Failure (TTF)
Description
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.
Time Frame
Baseline Up to 4 years
Title
Overall Survival (OS)
Description
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).
Time Frame
Baseline Until Death (Up to 4 years)
Other Pre-specified Outcome Measures:
Title
Maximum Observed Plasma Concentration (Cmax)
Description
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.
Time Frame
0 hours (pre-dose), 0.5 hours, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Description
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.
Time Frame
0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment
Title
Plasma Decay Half-Life (t1/2)
Description
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.
Time Frame
0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment
Title
Area Under the Concentration-Time Curve (AUC)
Description
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.
Time Frame
0 hours (pre-dose), 0.5 hours, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment
Title
Clearance (CLss) of Temsirolimus
Description
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.
Time Frame
0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment
Title
Volume of Distribution at Steady State (Vss) of Temsirolimus
Description
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.
Time Frame
0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Pfizer Investigational Site
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Pfizer Investigational Site
City
Beijing
ZIP/Postal Code
100036
Country
China
Facility Name
Pfizer Investigational Site
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Pfizer Investigational Site
City
Chiba
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Gunma
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Ibaraki
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kagoshima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kyoto
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nara
Country
Japan
Facility Name
Pfizer Investigational Site
City
Okayama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shizuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yamagata
Country
Japan
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
135 710
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3066K1-2217&StudyName=Study%20Evaluating%20The%20Safety%2C%20Efficacy%20%26%20Pharmacokinetics%20Of%20Temsirolimus%28CCI-779%29%20In%20Subjects%20With%20Advanced%20Renal%20Cell%20Carcinoma
Description
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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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