Tesetaxel for Previously Treated Patients With Bladder Cancer

≥ 3-month response rate

Proportion of patients with a confirmed complete or partial response ≥ 3 months in duration

Time frame: 12 months from date of first dose of study medication for last patient enrolled

Disease control rate

Proportion of patients with a confirmed complete or partial response of any duration or stable disease ≥ 3 months in duration

Time frame: 12 months from date of first dose of study medication for last patient enrolled

Durable response rate

Proportion of subjects with a confirmed complete or partial response ≥ 6 months in duration

Time frame: 12 months from date of first dose of study medication for last patient enrolled

Duration of response

Date when response criteria are first met to the date when progression is first documented

Time frame: 12 months from date of first dose of study medication for last patient enrolled

Time to progression

Date of first dose of study medication to the date when progression is first documented

Time frame: 12 months from date of first dose of study medication for last patient enrolled

Safety

Adverse events and clinical laboratory tests

Time frame: Up to 30 days after the last dose of study medication for a specific patient