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A Study of Intravesical Qapzola (Apaziquone) as a Surgical Adjuvant in Patients Undergoing TURBT

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ClinicalTrials.gov Identifier: NCT03224182
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

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

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: Qapzola Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized, multicenter, two-arm, double-blind, placebo-controlled study of Qapzola in patients with low- to intermediate-risk NMIBC.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : June 28, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Qapzola
One dose of 8mg Qapzola on Day 1
Drug: Qapzola
One dose of 8 mg Qapzola on Day 1

Placebo Comparator: Placebo
One dose of placebo on Day 1
Drug: Placebo
One dose of Placebo on Day 1




Primary Outcome Measures :
  1. Time to Recurrence [ Time Frame: Up-to 5 years ]
    To evaluate the Time to Recurrence in patients with low- to intermediate-risk non-muscle invasive bladder cancer (NMIBC) who receive either 8 mg Qapzola or placebo post transurethral resection of bladder tumor (TURBT).


Secondary Outcome Measures :
  1. 2-Year Recurrence Rate [ Time Frame: 2- years for each patient ]
    proportion of patients who have a confirmed recurrence before or at the 2-year follow up period for each treatment arm.

  2. Time to Disease Progression [ Time Frame: up to 60 months ]
    Patients will be followed every 3 months for two years then every 6 months up to 60 months with surveillance cystoscopy and will complete the trial at documented recurrence regardless of progression. Progression is defined in the protocol as invasion into detrusor muscle >T2 disease. As these low and intermediate risk NMIBC groups are at high risk of recurrence and low risk of progression this is only secondary outcome.

  3. Safety - rate of treatment-related adverse events [ Time Frame: Up to 5 years ]
    Safety will be assessed by reported/elicited adverse events (AEs) that are related to the study drug regardless of treatment group.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224182


Contacts
Contact: Nawazish Khan, MD 949-743-9325 spi-qap-306@sppirx.com

Locations
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53705
Contact: Sarah Sund    608-265-0027    sund@ortho.wisc.edu   
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT03224182     History of Changes
Other Study ID Numbers: SPI-QAP-306
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Apaziquone
Antineoplastic Agents