NCT00578526

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2014

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

6.3 years

First QC Date

December 19, 2007

Last Update Submit

August 20, 2018

Conditions

Urothelial CancerBladder CancerAdult

Keywords

urothelial cancertargeted therapyantiangiogenesis therapySU011248clinical trial

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    4 months

Secondary Outcomes (5)

  • objective response rate

    Study Duration

  • duration of response

    study duration

  • Change in health-related quality of life

    Study Duration

  • Number of participants that develop an adverse event to treatment.

    Study Duration

  • Overall Survival

    Study Duration

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

SU011248 - 4 weeks on followed by 2 weeks rest period every 6 weeks

Drug: SU011248

Arm 2

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

SU011248DRUG

50 mg capsule OD PO for 28 days followed by 14 days of rest until tumor progression

Also known as: Sutent, Sunitinib
Arm 1
PlaceboDRUG

50 mg capsule OD PO for 28 days then 14 days rest until disease progression

Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

London Health Sciences Centre

London, Ontario, T6A 4L6, Canada

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Tina Cheng, M.D.

    Tom Baker Cancer Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 21, 2007

Study Start

April 1, 2008

Primary Completion

July 16, 2014

Study Completion

July 16, 2014

Last Updated

August 22, 2018

Record last verified: 2018-08

Locations

CA(5)