SU011248 for Platinum-Refractory Urothelial Cancer Evalua... | NCT00578526

Studies
SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial

NCT00578526

Sponsor

AHS Cancer Control Alberta

Status

Completed

Last Update Posted

Aug 22, 2018Actual

Enrollment

64Actual

Phase

Phase 2

Conditions

Urothelial Cancer
Bladder Cancer
Adult

Interventions

SU011248
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Jul 16, 2014Actual

Completion Date

Jul 16, 2014Actual

First Submitted Date

Dec 19, 2007

First Submission Date that Met QC Criteria

Dec 20, 2007

First Posted Date

Dec 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2018

Last Update Posted Date

Aug 22, 2018Actual

Name	Class
Pfizer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
SU011248	Drug	50 mg capsule OD PO for 28 days followed by 14 days of rest until tumor progression	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival		4 months

Secondary Outcomes

Measure	Description	Time Frame
objective response rate		Study Duration
duration of response		study duration
Change in health-related quality of life

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tina Cheng, M.D.	Tom Baker Cancer Centre	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tom Baker Cancer Centre		Calgary	Alberta	T2N 4N2	Canada
Cross Cancer Institute

Condition Browse Module

MeSH Terms

ID	Term
D001749	Urinary Bladder Neoplasms

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077210	Sunitinib

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided