Advanced Renal Cell CarcinomaPhase 2NCT00494091
Study Evaluating The Safety, Efficacy & Pharmacokinetics Of Temsirolimus(CCI-779) In Subjects With Advanced Renal Cell Carcinoma
A Phase 2 study testing Temsirolimus (CCI-779) in people with Advanced Renal Cell Carcinoma, run by Pfizer at 24 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Renal Cell Carcinoma
- What is being tested?
- Temsirolimus (CCI-779)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 24 sitesin 3 countries
- Study dates
- Feb 2007to Mar 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
24 sites in 3 countries.
24 sites in 3 countries
Japan14 sites
Pfizer Investigational Site
Chiba
Pfizer Investigational Site
Fukuoka
Pfizer Investigational Site
Gunma
Pfizer Investigational Site
Hokkaido
Pfizer Investigational Site
Ibaraki
Pfizer Investigational Site
Kagawa
Pfizer Investigational Site
Kagoshima
Pfizer Investigational Site
Kyoto
Pfizer Investigational Site
Nara
Pfizer Investigational Site
Okayama
Pfizer Investigational Site
Osaka
Pfizer Investigational Site
Shizuoka
Pfizer Investigational Site
Tokyo
Pfizer Investigational Site
Yamagata
China6 sites
Pfizer Investigational Site
Beijing, 100021
Pfizer Investigational Site
Beijing, 100036
Pfizer Investigational Site
Beijing, 100730
Pfizer Investigational Site
Nanjing, Jiangsu, 210002
Pfizer Investigational Site
Shanghai, 200032
Pfizer Investigational Site
Shanghai, 200127
South Korea4 sites
Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 120-752
Pfizer Investigational Site
Seoul, 135 710
Pfizer Investigational Site
Seoul, 138-736
About this study
Official title: 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.
- Conditions
- Advanced Renal Cell Carcinoma
- Being tested
- Temsirolimus (CCI-779)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temsirolimus (CCI-779)Drug
Also called Torisel
20 mg/m2 IV TEMSR weekly (Japan, n=6)
Temsirolimus (CCI-779)Drug
Also called Torisel
25 mg IV TEMSR weekly (all other pts)
| Study group | Role | What they receive |
|---|---|---|
| A. | Experimental | Not described Receives: Drug: Temsirolimus (CCI-779) |
| B. | Experimental | Not described Receives: Drug: Temsirolimus (CCI-779) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline Up to 4 years
Secondary outcomes (5)
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.
Measured: Baseline Up to 4 years
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.
Measured: Baseline Up to 4 years
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.
Measured: Baseline Up to 4 years
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.
Measured: Baseline Up to 4 years
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).
Measured: Baseline Until Death (Up to 4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startFeb 2007
- Primary completionMay 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494091
- Sponsor's protocol ID
- 3066K1-2217
- Other IDs
- B1771002
- Status last verified
- Mar 2013
- First submitted
- 28 Jun 2007
- Last updated
- 21 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Non Randomized, Open Label Study Of Temsirolimus (CCI-779) In Subjects With Advanced Renal Cell Carcinoma (RCC)
- ClinicalTrials.gov ID
- NCT00494091
- Acronym / sponsor ID
- 3066K1-2217
- Conditions
- Advanced Renal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- May 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 29 Jun 2007 (estimated)
- Results
- Posted 9 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A. | Experimental | Drug: Temsirolimus (CCI-779) |
| B. | Experimental | Drug: Temsirolimus (CCI-779) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temsirolimus (CCI-779)Also: Torisel20 mg/m2 IV TEMSR weekly (Japan, n=6) | Drug | A. |
| Temsirolimus (CCI-779)Also: Torisel25 mg IV TEMSR weekly (all other pts) | Drug | B. |
Primary outcome
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).
5 secondary outcomes
Progression-free Survival (PFS)
Time frame: Baseline Up to 4 years
Percentage of Participants With Objective Response
Time frame: Baseline Up to 4 years
Duration of Response
Time frame: Baseline Up to 4 years
Time to Treatment Failure (TTF)
Time frame: Baseline Up to 4 years
Overall Survival (OS)
Time frame: Baseline Until Death (Up to 4 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
24 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temsirolimus (CCI-779) in people with Advanced Renal Cell Carcinoma, run by Pfizer at 24 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Japan, China, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Clinical Benefit (time frame: Baseline Up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2013.