The medical condition under investigation is noninvasive bladder cancer in patients undergoing transurethral resection of bladder tumor. MedDRA version: 9.1 Level: LLT Classification code 10005005 Term: Bladder cancer recurrent MedDRA version: 9.1 Level: LLT Classification code 10005007 Term: Bladder cancer stage 0, without cancer in situ MedDRA version: 9.1 Level: LLT Classification code 10005003 Term: Bladder cancer
Conditions
Interventions
Product Name: EOquin
Pharmaceutical Form: Powder for bladder irrigation
INN or Proposed INN: Apaziquone
CAS Number: 114560-48-4
Other descriptive name: E09, NOR-701, NSC-382459
Concentration unit: mg/
Sponsors
Spectrum Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient provides written informed consent. 2. Patient at least 18 years old. 3. Patient has transitional cell carcinoma of the bladder with clinically apparent tumor Ta, grade G1-G2. 4. If the patient is a female of childbearing potential, is using an acceptable/effective method of contraception. 5. If the patient is a female of childbearing potential, she has had a negative serum pregnancy test within the past 14 days. 6. Patient willing and able to abide by the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient may not have more than 4 bladder tumors. 2. Any single bladder tumor may not exceed 3.5 cm in diameter. 3. Patient must not have a single, primary bladder tumor 2 mg/dL. 12. Patient cannot have a known immunodeficiency disorder. 13. Patient cannot have received any investigational treatment within the past 30 days. 14. Patient cannot be breast feeding. 15. Patient cannot have a history of interstitial cystitis. 16. Patient cannot have a history of allergy to red color food dye. 17. Patient cannot have had transitional cell carcinoma of the bladder within the past 4 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the recurrence rate at 2 years in randomized patients with tumor histology Ta, G1-G2 who receive transurethral recection of bladder tumor (TUR-BT) plus EOquin® versus those who receive TUR-BT plus placebo.;Secondary Objective: 1) To evaluate time to first recurrence in patients with tumor histology Ta, G1-G2 who receive TUR-BT plus EOquin® versus those who receive TUR-BT plus placebo. 2) To evaluate progression to higher stage or grade, number of recurrences per patient, disease free interval, disease free survival and overall survival. 3) To assess the safety of EOquin® instilled into the bladder in the early postoperative period. 4)To assess functional bladder capacity in a 150 subject subset of randomized patients.;Primary end point(s): The primary efficacy assessment will be the recurrence rate at 2 years in patients with Ta, G1-G2 histology receiving one immediate instillation of EOquin® or placebo following TUR-BT. These patients will be assessed cystoscopically at 3-month intervals calculated from the time of randomization day. For patients with higher grade and stage tumors, for tumors other than stage Ta, and grade G1-G2 recurrence will be assessed cystoscopically at 3-month intervals calculated from the time of start of their additional chemo- or immunotherapy. The date of the biopsy procedure at which the bladder tumor was confirmed histologically will be used as the date of recurrence. Tumor stage and grade will be assessed by a blinded central laboratory that specializes in urologic pathology. | — |
Countries
Poland
Outcome results
None listed