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Spots Global Cancer Trial Database for Pazopanib Hydrochloride in Treating Patients With Metastatic Urethral Cancer or Bladder Cancer That Has Relapsed or Not Responded to Treatment

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Trial Identification

Brief Title: Pazopanib Hydrochloride in Treating Patients With Metastatic Urethral Cancer or Bladder Cancer That Has Relapsed or Not Responded to Treatment

Official Title: Phase 2 Study With the Multi-Targeted Tyrosine-Kinase Inhibitor Pazopanib (GW786034) for Patients With Relapsed or Refractory Urothelial Cancer

Study ID: NCT01031875

Study Description

Brief Summary: RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well pazopanib hydrochloride works in treating patients with or metastatic urothelial cancer or bladder cancer that has relapsed or not responded to treatment.

Detailed Description: OBJECTIVES: Primary * To evaluate the activity of daily oral doses of pazopanib hydrochloride monotherapy in patients with relapsed/refractory metastatic urothelial carcinoma or transitional cell tumors. Secondary * To evaluate the safety and tolerability of pazopanib hydrochloride monotherapy in a population of chemotherapy pretreated patients. * To assess progression-free survival of these patients. Tertiary * To evaluate the ability of whole-body 18FDG-PET to image metastases and monitor tumor response and to determine the rate of concordance with CT imaging and RECIST response criteria. * To evaluate the relationship existing between tumor response measured by 18FDG-PET and progression-free survival. OUTLINE: This is a multicenter study. Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo whole-body 18FDG-PET at baseline and periodically. After completion of study treatment, patients are followed for 2 years.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Fondazione Istituto Nazionale dei Tumori, Milan, , Italy

Contact Details

Name: Roberto Salvioni, MD

Affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Role: STUDY_CHAIR

Name: Nicola Nicolai, MD

Affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Role:

Name: Andrea Necchi, MD

Affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Role:

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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