Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC

• Status: Terminated
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Nanoxel®M is effective in the treatment of patients with recurrent Ta and T1 who experienced treatment failure with at least one prior BCG intravesical treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samyang Biopharmaceuticals Corporation
• Treatments: Docetaxel; Ethanol; Mitomycin; Mitomycins

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of superficial transitional cell carcinoma of the bladder (Ta, T1)

• Recurrent superficial bladder cancer refractory to Bacillus Calmette-Guerin (BCG)

• No previous intravesical therapy for 6 weeks

• No history of prior radiation to the pelvis

• Peripheral neuropathy ≤ grade 1

• Eastern Cooperative Oncology Group (ECOG) performance status 0 t0 2

• Adequate hematopoietic and hepatic parameters

Exclusion Criteria:

• Muscle invasive disease (T2-T4)

• Any other malignancy diagnosed within 2 years of study entry (Except basal or squamous cell skin cancers or noninvasive cancer of the cervix)

• Participation in any other research protocol involving administration of an investigational agent within 3 months before study entry

• History of sensitivity reaction to docetaxel

• Prescribed immunosuppressive medications because of a confounding medical condition

• Female patients who were pregnant or lactating