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

Advanced Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00494091
• Other study ID #: 3066K1-2217
• Secondary ID: B1771002
• Status: Completed
• Phase: Phase 2
• First received: June 28, 2007
• Last updated: March 15, 2013
• Start date: February 2007
• Est. completion date: March 2012

Study information

• Verified date: March 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of HealthChina: Food and Drug AdministrationJapan: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: March 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Temsirolimus (CCI-779)
20 mg/m2 IV TEMSR weekly (Japan, n=6)
• Temsirolimus (CCI-779)
25 mg IV TEMSR weekly (all other pts)

Locations

Country	Name	City	State
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Nanjing	Jiangsu
China	Pfizer Investigational Site	Shanghai
China	Pfizer Investigational Site	Shanghai
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
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

China,  Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maximum Observed Plasma Concentration (Cmax)	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.	0 hours (pre-dose), 0.5 hours, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment	No
Other	Time to Reach Maximum Observed Plasma Concentration (Tmax)	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.	0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment	No
Other	Plasma Decay Half-Life (t1/2)	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.	0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment	No
Other	Area Under the Concentration-Time Curve (AUC)	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.	0 hours (pre-dose), 0.5 hours, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment	No
Other	Clearance (CLss) of Temsirolimus	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.	0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment	No
Other	Volume of Distribution at Steady State (Vss) of Temsirolimus	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.	0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment	No
Primary	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).	Baseline Up to 4 years	No
Secondary	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.	Baseline Up to 4 years	No
Secondary	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.	Baseline Up to 4 years	No
Secondary	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.	Baseline Up to 4 years	No
Secondary	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.	Baseline Up to 4 years	No
Secondary	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).	Baseline Until Death (Up to 4 years)	No

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