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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01316874
Other study ID # A9301/A9302
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received March 15, 2011
Last updated June 10, 2015
Start date November 1993
Est. completion date April 1997

Study information

Verified date June 2015
Source Endo Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Valrubicin, 800 mg
Investigator will be responsible for regulating the use of concomitant medications (systemic and/or topical anticholinergic therapy or topical anesthesia) and other medications.

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Sponsors (1)

Lead Sponsor Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Steinberg G, Bahnson R, Brosman S, Middleton R, Wajsman Z, Wehle M. Efficacy and safety of valrubicin for the treatment of Bacillus Calmette-Guerin refractory carcinoma in situ of the bladder. The Valrubicin Study Group. J Urol. 2000 Mar;163(3):761-7. Erratum in: J Urol. 2008 Jan;179(1):386. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary To evaluate the qualitative toxicities associated with intravesical therapy using AD 32 (valrubicin). 6 weeks Yes
Secondary To determine the concentration of anthracyclines in the voided urine of patients who chose to participate in a urine recovery study. 6 weeks Yes
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