The medical condition under investigation is noninvasive bladder cancer in patients undergoing transurethral resection of bladder tumor/tumors. MedDRA version: 14.0 Level: PT Classification code 10005007 Term: Bladder cancer stage 0, without cancer in situ System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.0 Level: PT Classification code 10005005 Term: Bladder cancer recurrent System Organ Class: 10029104 - Neoplasms benign, ma
Conditions
Interventions
Product Name: apaziquone
Pharmaceutical Form: Powder for solution for intravesical use
INN or Proposed INN: apaziquone
CAS Number: 114560-48-4
Current Sponsor code: not applicable
Other descriptive na
Sponsors
Spectrum Pharmaceuticals, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Open Phase Inclusion Criteria 1. Has the patient given written informed consent and is the patient willing and able to abide by the protocol? 2. Is the patient 18 years old or above? 3. If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception? 4. Does the female patient of childbearing potential have a negative serum pregnancy test at screening? 5. Does the patient with clinically apparent primary or recurrent low grade Ta NMIBC have : • multiple tumors (2-7) • No single Tumor > 3 cm • No history / evidence of Tis Or does the patient with clinically apparent primary or recurrent high grade Ta NMIBC have: • A single tumor that is = 3 cm • No history / evidence of Tis 6. Is the patient able to retain bladder instillations for a minimum of 60 minutes (+/- 6 minutes)? 7. Did the patient have upper urinary tract evaluation to exclude urothelial carcinoma, hydronephrosis or renal cell carcinoma or other renal cancers in the 6 months prior to study screening? 8. Is patient’s urethra (including prostatic urethra in men) endoscopically free of any visible TCC? 9. For patients with recurrent tumor, did the patient have at least a 6-month cystoscopically-confirmed tumor-free interval between the last tumor recurrence and the time of screening? 10. Has the male patient with a prostate specific antigen (PSA) between 4 and 10 ng/mL had a diagnostic evaluation that reasonably excludes the diagnosis of prostate cancer in the opinion of the Investigator? Double-Blind Phase Inclusion Criteria 1. Was all visible tumor resected at the initial TURBT? 2. Does Central Pathology review of the patient’s bladder tumor confirm: • Low grade Ta disease for multiple tumors (2 - 7) or • High Grade Ta disease for single tumor • No microscopic evidence of lymphovascular invasion and/or evidence of tumor thromboemboli All questions must be answred 'YES' in order for patient to be included in the study. 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 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 1. Has the patient received any previous pelvic radiotherapy (includes external beam and/or brachytherapy)? 2. Has the patient ever received apaziquone? 3. Has the patient received an induction course (completed 5 of 6 scheduled weekly instillations) of intravesical BCG (± interferon) with the last dose given less than 12 months ago? 4. Has the patient had any prior intravesical chemotherapy, exclusive of single-dose adjuvant intravesical chemotherapy immediately post-TURBT? 5. Does the patient have a history of urinary retention or a post void residual = 250 cc by bladder scan or ultrasound (post void residual test may be repeated up to 3 times)? 6. Does the patient have or has the patient had any bladder tumor with histology other than transitional cell carcinoma? 7. Does the patient have or has the patient had micro-papillary transitional cell carcinoma? 8. If the patient has recurrent papillary disease of the bladder, has the pathology been anything other than pTa in the past? 9. Does the patient have an active urinary tract infection confirmed by culture or a documented history of recurrent UTI (= 6 for females and =2 for males per year) in the prior 2 years? 10. Does the patient have a bleeding disorder or a screening platelet count 10 ng/mL? 13. Does the patient have a history of Acquired Immunodeficiency Syndrome or HIV positive? 14. Does the patient have a condition or a concurrent severe and/or uncontrolled medical or psychiatric disease (e.g., uncontrolled diabetes, decompensated congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, or an active uncontrolled infection), which could compromise participation, compliance with scheduled visits and/or completion of the study? 15. Has the patient participated in an investigational protocol within the past 90 days? 16. Is the patient pregnant or breast feeding? 17. Does the patient have a life expectancy of <3 years? 18. Has the patient had any other malignancy or received therapy for any malignancy in the last five years except • non-melanoma skin tumors • stage 0 (in situ) cervical carcinoma • undetectable PSA for =1 year following definitive therapy for localized prostate cancer? 19. Does the patient have documented vesicoureteral reflux or an indwelling ureteral stent? 20. Does the patient have tumor in a bladder diverticulum? 21. Does the patient have a known allergy to red color food dye? The patient will not be entered into study if any of above listed questions is answered YES.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Time to recurrence of cancer in the bladder;Secondary Objective: • Recurrence rate at 24 months • Recurrence rate at 12 months • Time to Progression • Safety and tolerability;Primary end point(s): Time when there is first confirmed recurrence of bladder cancer after the initial TURBT during which all tumors have been resected and patient has received one dose of IMP in the immediate post operative period after TURBT followed by either 6 weekly instillations of IMP or placebo.;Timepoint(s) of evaluation of this end point: Patient will be followed by cystosopy every 3 months for tumor recurrence for the total duration of 24 months from the time of receiving the first IMP instillation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Recurrence rate in 24 months Recurrence rate in 12 months Time to progression Safety and Tolerability ;Timepoint(s) of evaluation of this end point: Patient will be followed by cystosopy every 3 months for tumor recurrence for the total duration of 24 months from the time of receiving the first IMP instillation. Advrese events and serious events both related and unrealted will be collected and reviewed on ongoing basis to assess safety and tolerability. | — |
Countries
Belgium, Czech Republic, Netherlands, Poland, Portugal, Slovakia, Spain, United States
Contacts
Public ContactMarzena Smoch
PharmaTrials-Polska
Outcome results
None listed