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Carcinoma, Renal CellPhase 2NCT00077974

A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma.

A Phase 2 study testing SU011248 in people with Carcinoma, Renal Cell, run by Pfizer at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
SU011248
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
15 sitesUnited States
Study dates
Feb 2004to Sep 2008
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cytokine refractory metastatic renal cell carcinoma with clear cell component
  • Radiographic evidence of disease progression during or within 9 months of completion of 1 cytokine therapy
  • Prior nephrectomy

Who cannot join

  • Prior treatment with any systemic therapy other than 1 cytokine therapy
  • History of or known brain metastases
  • Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study start

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Pfizer Investigational Site

    Ann Arbor, Michigan, 48109

  • Pfizer Investigational Site

    Boston, Massachusetts, 02114

  • Pfizer Investigational Site

    Boston, Massachusetts, 02115

  • Pfizer Investigational Site

    Boston, Massachusetts, 02215

  • Pfizer Investigational Site

    Cleveland, Ohio, 44195

  • Pfizer Investigational Site

    Duarte, California, 91010-3000

  • Pfizer Investigational Site

    Durham, North Carolina, 27705

  • Pfizer Investigational Site

    Madison, Wisconsin, 53792

  • Pfizer Investigational Site

    New York, New York, 10021

  • Pfizer Investigational Site

    New York, New York, 10022

  • Pfizer Investigational Site

    Pasadena, California, 91105

  • Pfizer Investigational Site

    Philadelphia, Pennsylvania, 19111

  • Pfizer Investigational Site

    Portland, Oregon, 97213

  • Pfizer Investigational Site

    Rochester, Minnesota, 55905

  • Pfizer Investigational Site

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma

To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma

Being tested
SU011248
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SU011248Drug

    Also called Sunitinib, SUTENT

    50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity

Study groups in NCT00077974
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: SU011248

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)

    Overall confirmed objective response = confirmed Complete Response (CR) or confirmed Partial Response (PR) according to RECIST. CR defined as disappearance of all target lesions. PR defined as >= 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

    Measured: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter

Secondary outcomes (11)

  1. Time to Tumor Progression (TTP)

    Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).

    Measured: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter

  2. Duration of Response (DR)

    Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.

    DR was calculated for the subgroup of patients with a confirmed objective tumor response.

    Measured: Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer

  3. Overall Survival (OS)

    Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the subject current status was death).

    Measured: From start of study treatment until death

  4. Progression-free Survival (PFS)

    Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").

    Measured: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death

  5. Percent Chance of Patient Survival

    Probability of survival 1 year and 2 years after the first dose of study treatment

    Measured: From start of study treatment until death

  6. Observed Plasma Trough Concentrations of Sunitinib

    Observed plasma trough (predose) (Cmin) concentrations of sunitinib

    Measured: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater

  7. Observed Plasma Trough Concentrations of Sunitinib Metabolite

    Observed plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662)

    Measured: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater

  8. Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite

    Observed plasma trough (predose) concentrations of sunitinib plus its metabolite (SU012662)

    Measured: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater

  9. Dose Corrected Plasma Trough Concentrations of Sunitinib

    Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib. Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.

    Measured: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater

  10. Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite

    Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662). Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.

    Measured: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater

  11. Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite

    Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib plus its metabolite (SU012662). Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.

    Measured: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2004 (estimated)
  2. Study startFeb 2004
  3. Primary completionSep 2008
  4. Study completionSep 2008

Resources

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
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00077974
Sponsor's protocol ID
A6181006
Status last verified
Oct 2010
First submitted
13 Feb 2004
Last updated
13 Oct 2010
Data monitoring committee
Yes

Publications

  • de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.

    PubMed 28410911

  • Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.

    PubMed 27238653

  • Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.

    PubMed 25577718

  • Motzer RJ, Rini BI, Bukowski RM, Curti BD, George DJ, Hudes GR, Redman BG, Margolin KA, Merchan JR, Wilding G, Ginsberg MS, Bacik J, Kim ST, Baum CM, Michaelson MD. Sunitinib in patients with metastatic renal cell carcinoma. JAMA. 2006 Jun 7;295(21):2516-24. doi: 10.1001/jama.295.21.2516.

    PubMed 16757724

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SU011248 in people with Carcinoma, Renal Cell, run by Pfizer at 15 sites in United States.

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 3 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 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. 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 3 Nov 2009). 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?

Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST) (time frame: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00077974, which also lists 4 linked publications.

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 13 Oct 2010.

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