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A Phase 3 International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Multiple Instillations of Intravesical Apaziquone vs. Placebo in Patients With Low-Intermediate Risk Non-Muscle Invasive Bladder Cancer (NMIBC)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Bladder Cancer

Thank you

Trial Information

A Phase 3 International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Multiple Instillations of Intravesical Apaziquone vs. Placebo in Patients With Low-Intermediate Risk Non-Muscle Invasive Bladder Cancer (NMIBC)


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?

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

Exclusion Criteria:

Open Phase 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 < 50 x 109/L?

11. Does the patient have a screening hemoglobin < 10 mg/dL?

12. Does the male patient have a serum PSA > 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?

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Time to Recurrence

Outcome Description:

Time to recurrence (from randomization) for eligible patients with Low- intermediate risk NMIBC, who had undergone TURBT followed by, a single instillation of apaziquone immediately post TURBT and multiple instillations of apaziquone or placebo.

Outcome Time Frame:

Recurrence of cancer in the bladder during 24 months of follow-up

Safety Issue:

No

Principal Investigator

Randil Clark, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Idaho Urology

Authority:

United States: Food and Drug Administration

Study ID:

SPI-1011

NCT ID:

NCT01410565

Start Date:

July 2011

Completion Date:

December 2015

Related Keywords:

  • Bladder Cancer
  • Bladder Cancer
  • Non-Muscle Invasive Bladder Cancer
  • NMIBC
  • Apaziquone
  • EOquin
  • GU Cancer
  • TURBT
  • Urinary Bladder Neoplasms

Name

Location

University of MinnesotaMinneapolis, Minnesota  55455
North Idaho UrologyCouer D'Alene, Idaho  83814
Connecticut Clinical Research CenterWaterbury, Connecticut  06708-2652
Urological Associates Of LancasterLancaster, Pennsylvania  17604-3200
South Orange County Medical Research CenterLaguna Hills, California  92653
Northeast Indiana Research, LLCFort Wayne, Indiana  46825-1675
Carolina Urologic Research CenterMyrtle Beach, South Carolina  29572
Urology of Virginia, PCNorfolk, Virginia  23507
Regional Urology, LLCShreveport, Louisiana  71106
Valley Urologic AssociatesGoodyear, Arizona  85338
Anne Arundel UrologyAnnapolis, Maryland  21401
Urology EnterprisesMarietta, Georgia  30060
University Urology AssociatesNew York, New York  10016
Urology Associates of South TexasMcAllen, Texas  78503
The Urology Center of ColoradoDenver, Colorado  80211
Idaho Urologic Institute, P.A.Meridian, Idaho  83642
Five Valleys UrologyMissoula, Montana  59802
Delaware Valley Urology, LLC - VoorheesVoorhees, New Jersey  08043
Delaware Valley Urology, LLC-WestamptonWestampton, New Jersey  08060
Urology Associates of Rochester, LLCRochester, New York  14618
TriState Urologic Services PSC, Inc.Cincinnati, Ohio  45212
Integrity Medical Research, LLCMountlake Terrace, Washington  98043
Spectrum Health Medical GroupGrand Rapids, Michigan  69546
Urology of Virginia, PLLCVirginia Beach, Virginia  23462
Precision Trials, LLCPhoenix, Arizona  85032
First Urology, PSCJeffersonville, Indiana  47130
Urologic Consultants of Southeastern Pennsylvania, LLPBala Cynwyd, Pennsylvania  19004
Urology Health SpecialistsBryn Mawr, Pennsylvania  19010