Intravesical AD 32 (Valrubicin) in Patients With Carcinoma in Situ (CIS) of the Bladder Who Have Failed or Have Recurrence Following Treatment With Bacillus Calmette-guerin (BCG)

Phase 2

Completed

• Conditions: Bladder Cancer; Carcinoma in Situ
• Interventions: Drug: Valrubicin, 800 mg

• Registration Number: NCT01316874
• Lead Sponsor: Endo Pharmaceuticals

Brief Summary

This is a Phase II/Phase III study of intravesical AD 32 (valrubicin) in patients with carcinoma in situ (CIS) who have been previously treated with intravesical Bacillus Calmette-Guerin (BCG) for CIS and in whom recurrence or failure has occurred after multiple courses of intravesical treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 1993-11
• Primary Completion: 1997-04
• Study Completion: 1997-04
• Study First Submitted: 2011-03-15
• Study First Submitted QC: 2011-03-15
• Study First Posted: 2011-03-16
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-10
• Last Update Posted: 2015-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AD32 (valrubicin)	Valrubicin, 800 mg	800mg, once weekly for 6 weeks

Primary Outcome Measures

Name	Time	Method
Assess the efficacy of AD 32 (valrubicin) in patients with CIS of the bladder who previously have been treated with BCG for CIS and in whom recurrence or failure had occurred after multiple courses of intravesical treatment.	12 weeks

Secondary Outcome Measures

Name	Time	Method
To determine the concentration of anthracyclines in the voided urine of patients who chose to participate in a urine recovery study.	6 weeks
To evaluate the qualitative toxicities associated with intravesical therapy using AD 32 (valrubicin).	6 weeks

Trial Locations

Locations (39)

Stacy Childs, MD; 🇺🇸 Alabaster, Alabama, United States

William Bohnert, MD; 🇺🇸 Phoenix, Arizona, United States

Scott Swanson, MD; 🇺🇸 Scottsdale, Arizona, United States

Bruce Dalkin, MD; 🇺🇸 Tucson, Arizona, United States

Donald Gleason, MD; 🇺🇸 Tucson, Arizona, United States

William Friedel, MD; 🇺🇸 La Mesa, California, United States

Stephen Auerbach, MD; 🇺🇸 Newport Beach, California, United States

William Moseley, MD; 🇺🇸 San Diego, California, United States

Standley Brosman, MD; 🇺🇸 Santa Monica, California, United States

Eugene Dula, MD; 🇺🇸 Van Nuys, California, United States

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