SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2014-07-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to find out if SU011248 works and if it is safe in patients with advanced transitional cell carcinoma.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Trial of Maintenance SUO11248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma

NCT00393796

Bladder Cancer

TERMINATED PHASE2

A Study To Find The Best Dose Of SU011248 When Given With Pemetrexed, Pemetrexed And Cisplatin Or Pemetrexed And Carboplatin In Patients With Advanced Solid Tumors

NCT00528619

Neoplasms

COMPLETED PHASE1

Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Tumors

NCT00511849

Neoplasms

COMPLETED PHASE1

Study of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney Cancer

NCT00054886

Kidney Neoplasms

COMPLETED PHASE2

Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Cancer

NCT00712504

Advanced Solid Tumors Non Small Cell Lung Cancer

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urothelial Cancer Bladder Cancer Adult

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

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

Group Type ACTIVE_COMPARATOR

SU011248

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SU011248

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sutent, Sunitinib

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No