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

NCT00494091 | Completed Phase 2 Results

• 2 other identifiers: 3066K1-2217B1771002
• Study Type: interventional
• Target: 82
• Locations: 3 countries
• Sites: 24

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.

Conditions

Advanced Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Progression-free Survival (PFS)

  Baseline Up to 4 years

• Percentage of Participants With Objective Response

  Baseline Up to 4 years

• Duration of Response

  Baseline Up to 4 years

• Time to Treatment Failure (TTF)

  Baseline Up to 4 years

• Overall Survival (OS)

  Baseline Until Death (Up to 4 years)

Other Outcomes (6)

• Maximum Observed Plasma Concentration (Cmax)

  0 hours (pre-dose), 0.5 hours, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  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 (t1/2)

  0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment

Study Arms (2)

A.

EXPERIMENTAL

Drug: Temsirolimus (CCI-779)

B.

EXPERIMENTAL

Drug: Temsirolimus (CCI-779)

Interventions

Temsirolimus (CCI-779) DRUG

20 mg/m2 IV TEMSR weekly (Japan, n=6)

Also known as: Torisel

A.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (24)

Pfizer Investigational Site

Nanjing, Jiangsu, 210002, China

Location

Pfizer Investigational Site

Beijing, 100021, China

Location

Pfizer Investigational Site

Beijing, 100036, China

Location

Pfizer Investigational Site

Beijing, 100730, China

Location

Pfizer Investigational Site

Shanghai, 200032, China

Location

Pfizer Investigational Site

Shanghai, 200127, China

Location

Pfizer Investigational Site

Chiba, Japan

Location

Pfizer Investigational Site

Fukuoka, Japan

Location

Pfizer Investigational Site

Gunma, Japan

Location

Pfizer Investigational Site

Hokkaido, Japan

Location

Pfizer Investigational Site

Ibaraki, Japan

Location

Pfizer Investigational Site

Kagawa, Japan

Location

Pfizer Investigational Site

Kagoshima, Japan

Location

Pfizer Investigational Site

Kyoto, Japan

Location

Pfizer Investigational Site

Nara, Japan

Location

Pfizer Investigational Site

Okayama, Japan

Location

Pfizer Investigational Site

Osaka, Japan

Location

Pfizer Investigational Site

Shizuoka, Japan

Location

Pfizer Investigational Site

Tokyo, Japan

Location

Pfizer Investigational Site

Yamagata, Japan

Location

Pfizer Investigational Site

Seoul, 110-744, South Korea

Location

Pfizer Investigational Site

Seoul, 120-752, South Korea

Location

Pfizer Investigational Site

Seoul, 135 710, South Korea

Location

Pfizer Investigational Site

Seoul, 138-736, South Korea

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

temsirolimus

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2007
• First Posted: June 29, 2007
• Study Start: February 1, 2007
• Primary Completion: May 1, 2011
• Study Completion: March 1, 2012
• Last Updated: March 21, 2013
• Results First Posted: July 9, 2012

Record last verified: 2013-03

Locations

CN (6); JP (14); KR (4)