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BRIEF TITLE: Qapzola™ (Apaziquone) as a Chemotherapy Adjuvant to TransUrEthral Resection of Bladder Tumors in Patients With Low- To-Intermediate-Risk NMIBC (CONQUER)

A Randomized, Single-Dose, Double-Blind, Placebo-CONtrolled Phase 3 Study of Qapzola™ (Apaziquone) as a Chemotherapy Adjuvant to TransUrEthral Resection of Bladder Tumors in Patients With Low- To-Intermediate-Risk NMIBC (CONQUER)


  • Org Study ID: SPI-QAP-306
  • Secondary ID:
  • NCT ID: NCT03224182
  • NCT Alias:
  • Sponsor: Spectrum Pharmaceuticals, Inc - Industry
  • Source: Spectrum Pharmaceuticals, Inc

Description

To evaluate the Time to Recurrence in patients with low to intermediate risk non-muscle invasive bladder cancer (NMIBC)

Brief Summary

This is a randomized, multicenter, two-arm, double-blind, placebo-controlled study of Qapzola in patients with low- to intermediate-risk NMIBC, assessed according to the 2016 American Urology Association (AUA) Guidelines. Specifically, only patients with the following low-to intermediate risk tumor characteristics will be included in the study. 2016 American Urological Association Stratification for Non-Muscle Invasive Bladder Cancer: Low Risk - Low grade solitary Ta ≤3cm: a - PUNLMP: a, b Intermediate Risk - Recurrence within 1 year, low-grade Ta: a - Solitary low-grade Ta >3 cm: a - Low-grade Ta, multifocal: a - High-grade Ta, ≤3 cm (solitary tumor): a

Detailed Description


In addition to other Screening assessments, patients will undergo an assessment of urothelial
carcinoma of the bladder via cystoscopy for clinically apparent tumor of Ta histology,
including PUNLMP, although patients with strongly suspected PUNLMP at Screening or TURBT
should not be enrolled in the study. The qualifying cystoscopy may be performed up to 45 days
prior to signing the informed consent.

Eligible patients will be randomized in a 2:1 ratio to either:

- Arm 1: One dose of 8 mg Qapzola

- Arm 2: One dose of placebo

Once approved for randomization, patients will undergo TURBT on Day 1 and the study drug
instillation will occur at 60 ± 30 minutes post-TURBT and will be retained for 60 minutes (±5
minutes) in the bladder. All histology specimens will be reviewed by a local pathology
laboratory and all clinical treatment decisions will be based on the local pathology review.
Patient target disease will be confirmed and efficacy analyses will be performed based on the
pathology results. The target study population is low- to intermediate-risk patients who have
Ta histology, including PUNLMP, as confirmed by a pathology laboratory. Patients with
strongly suspected PUNLMP at Screening or TURBT should not be enrolled in the study. Patients
whose tumor histology does not meet the criteria for eligibility, as confirmed by pathology
(Non-Target Population), will be followed up for safety on Day 35 (±5 days) (Safety Follow-up
Visit) and will be discontinued from the study. If the pathology results are delayed beyond
35 days, the Safety Follow-up Visit will be conducted when the results are available for
these patients.

Patients who have pathology confirmed target histology will not receive additional
medications to treat NMIBC during the follow-up while on study. All target disease patients
will be followed until either a confirmed tumor recurrence, additional bladder cancer
treatments, or until the End-of-Study, whichever occurs first.

The primary analysis will be conducted once the required number of recurrence events are
observed. A recurrence is defined as any pathologically confirmed disease of ≥Ta histology or
CIS post-treatment. The number of events needed to perform the final primary endpoint
analysis was estimated based on the recurrence rate at 24 months from previous studies. The
follow-up schedule is below:

- Cystoscopic examination (all patients) and urine cytology (only patients with a Baseline
diagnosis of intermediate-risk NMIBC) every 3 months (±30 days) (calculated from date of
TURBT) for 2 years for tumor recurrence and progression and then every 6 months (±60
days) until either a confirmed tumor recurrence or the End-of-Study, whichever occurs
first.

- If at any time during the study there is a histologically confirmed tumor recurrence,
the patient will be discontinued from the study at that time and may then be treated per
the Investigator's standard of care.

The study will end (End-of-Study) when the required number of events for the primary endpoint
analysis are accrued.

Duration of Study: The duration of the study for each patient will be as follows:

- Screening Period: up to 30-days

- Treatment: Day 1

- Safety Follow-up: Day 35 (±5 days) (non-Target Population) or Month 3 Follow-up Visit
(Target Population)

- Follow-up Period: No follow-up in non-Target Population. Until either a confirmed tumor
recurrence or the End-of-Study, whichever occurs first in the Target Population.

Overal Status Start Date Phase Study Type
Recruiting June 28, 2017 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Time to Recurrence

Primary Outcome 1 - Time Frame: Up-to 5 years

Condition:

  • Bladder Cancer

Eligibility

Criteria:
Inclusion Criteria:

1. Patient must have a clinical diagnosis of low- to intermediate-risk non-muscle
invasive bladder cancer according to the 2016 American Urological Association (AUA)
Guidelines, except for strongly-suspected PUNLMP.

2. Patient must be willing to give written informed consent and must be able to adhere to
dosing and visit schedules, and meet all study requirements.

3. Patient is at least 18 years of age and <90 years of age at the time Informed Consent
is signed.

4. Patient must be willing to practice two forms of contraception, one of which must be a
barrier method, from study entry until at least 35 days after study treatment.
Patients surgically sterilized or who are postmenopausal for at least 1 year (defined
as more than 12 months since last menses) do not require contraception.

5. Females of childbearing potential must have a negative pregnancy test within 30 days
prior to randomization. Females who are postmenopausal for at least 1 year (defined as
more than 12 months since last menses) or are surgically sterilized do not require
this test.

Exclusion Criteria:

1. Patient has malignancy or life-threatening systemic disease or a history of advanced,
serious, life-threatening malignancy/disease within the last 5 years, except very
low-risk prostate cancer

2. Patient has used any investigational drugs, biologics (vaccines, antibodies), or
devices within 30 days prior to study treatment or has plans to use any of these
during the course of the study

3. Patient has received any pelvic radiotherapy (including external beam and/or
brachytherapy).

4. Patient has a history of allergy to red color food dye or any other component of
Qapzola, placebo, or their diluents

5. Patient has had a surgical procedure 4 weeks prior to TURBT or will have other
surgical procedures performed at the time of TURBT or within 4 weeks after TURBT

6. Patient has any unstable or uncontrolled medical condition that would make it
potentially unsafe to undergo TURBT including a previous stroke or myocardial
infarction within 6 months

7. Patient has an active uncontrolled infection, including a urinary tract infection,
underlying medical condition, or other serious illness that would impair the ability
of the patient to receive study treatment or undergo study procedures

8. Patient has a bleeding disorder or a screening platelet count <100×109/L, or requires
continuous anticoagulation or bridging anticoagulation during the procedure

9. Patient has a hemoglobin value <10 g/dL at Screening

10. Patient has ever had confirmed extravesical urothelial disease (upper tract and
urethral including prostatic urethral)

11. Patient with a history of previous bladder cancer:

- High-Risk NMIBC as classified per the 2016 AUA Guidelines

- Bladder cancer that was muscle invasive or positive for lymph node or distant
metastasis

12. Patient has received any previous intravesical therapy for bladder cancer-
chemotherapy, immunotherapy, or previous exposure to Qapzola in the last 3 years

13. Patient has a tumor in the bladder diverticulum

14. Patient has a history of interstitial cystitis

15. Patient is pregnant or breast-feeding
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Gender: All

Minimum Age: 18 Years

Maximum Age: 89 Years

Healthy Volunteers: No

Overall Contact

Name: Nawazish Khan, MD

Phone: 949-743-9325

Email: spi-qap-306@sppirx.com

Location

Facility Status Contact
University of Wisconsin
Madison, Wisconsin 53705
United States
Recruiting Sarah Sund
608-265-0027
sund@ortho.wisc.edu