SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial

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NCT00578526

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Study Location
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Urothelial Cancer, Bladder Cancer, Adult
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically/cytologically proven inoperable, metastatic or recurrent transitional cell carcinoma of the urothelial tract

- Mixed histology with predominant TCC allowed.

- Failed, intolerant or ineligible for cisplatin based chemo

- Measurable Disease (RECIST)Not previously irradiated.

- Recovered from previous acute treatment to grade 1(CTCAE Vers. 3.0)

- No weight loss >/- 10% within 28 days of day 0

- Adequate Organ Function

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Adenocarcinoma, squamous carcinoma or other histology without any components of
transitional carcinoma.


- Small cell histology


- More than one previous systemic chemo


- Excised metastases without remaining measureable disease


- Prior therapy with angiogenesis inhibitors

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Urothelial Cancer, Bladder Cancer, AdultSU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial
NCT00578526
  1. Calgary, Alberta
  2. Edmonton, Alberta
  3. Vancouver, British Columbia
  4. Hamilton, Ontario
  5. London, Ontario
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial
Official Title  ICMJE A Randomized, Placebo-controlled Phase II Study to Compare the Efficacy and Safety of SU011248 Versus Placebo in Patients With Advanced Urothelial Transitional Cell Carcinoma Who Have Failed or Are Intolerant to Cisplatin-based Chemotherapy
Brief Summary The purpose of this study is to find out if SU011248 works and if it is safe in patients with advanced transitional cell carcinoma.
Detailed Description

The study objectives include the determination of the antitumor effect of SU011248 in patients with urothelial transitional cell carcinoma and to also determine the toxicities and tolerability of SU011248 in patients with urothelial transitional cell carcinoma who have failed or are intolerant to cisplatin-based chemotherapy.

The primary endpoint of the study is to compare progression free survival at 4 months in patients who received SU011248 plus BSC versus patients who received placebo plus BSC

The secondary endpoint is to compare the objective response rate and duration of response in patients who received SU011248 plus BSC versus patients who received placebo plus BSC, to describe the QOL and safety profile of SU011248 when compared to placebo and to describe the overall survival in patients who received SU011248 plus BSC versus patients who received placebo plus BSC

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Urothelial Cancer
  • Bladder Cancer
  • Adult
Intervention  ICMJE
  • Drug: SU011248
    50 mg capsule OD PO for 28 days followed by 14 days of rest until tumor progression
    Other Name: Sutent, Sunitinib
  • Drug: Placebo
    50 mg capsule OD PO for 28 days then 14 days rest until disease progression
Study Arms  ICMJE
  • Active Comparator: Arm 1
    SU011248 - 4 weeks on followed by 2 weeks rest period every 6 weeks
    Intervention: Drug: SU011248
  • Placebo Comparator: Arm 2
    1 50 mg capsule OD PO for 4 weeks with 2 week rest until disease progression. Any patient with disease progression will be unblinded and patients on the placebo arm may then be considered for the open label Sutent treatment.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2007)		64
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 16, 2014
Actual Primary Completion Date July 16, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically/cytologically proven inoperable, metastatic or recurrent transitional cell carcinoma of the urothelial tract
  • Mixed histology with predominant TCC allowed.
  • Failed, intolerant or ineligible for cisplatin based chemo
  • Measurable Disease (RECIST)Not previously irradiated.
  • Recovered from previous acute treatment to grade 1(CTCAE Vers. 3.0)
  • No weight loss >/- 10% within 28 days of day 0
  • Adequate Organ Function

Exclusion Criteria:

  • Adenocarcinoma, squamous carcinoma or other histology without any components of transitional carcinoma.
  • Small cell histology
  • More than one previous systemic chemo
  • Excised metastases without remaining measureable disease
  • Prior therapy with angiogenesis inhibitors
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00578526
Other Study ID Numbers  ICMJE SPRUCE02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tina Cheng, AHS Cancer Control Alberta
Study Sponsor  ICMJE AHS Cancer Control Alberta
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Tina Cheng, M.D.Tom Baker Cancer Centre
PRS Account AHS Cancer Control Alberta
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP