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A Study of Intravesical Qapzola (Apaziquone) as a Surgical Adjuvant in Participants Undergoing Transurethral Resection of Bladder Tumor (TURBT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03224182
Recruitment Status : Terminated (Suspended development)
First Posted : July 21, 2017
Results First Posted : September 28, 2021
Last Update Posted : September 28, 2021
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 participants with low- to intermediate-risk non-muscle invasive bladder cancer (NMIBC), assessed according to the 2016 American Urology Association (AUA) Guidelines. Specifically, only participants with the following low-to intermediate-risk tumor characteristics were included in the study.

2016 American Urological Association Stratification for Non-Muscle Invasive Bladder Cancer:

Low Risk

  • Low grade solitary Ta ≤3 centimeters (cm)
  • Papillary urothelial neoplasm of low malignant potential (PUNLMP)

Intermediate Risk

  • Recurrence within 1 year, low-grade Ta
  • Solitary low-grade Ta >3 cm
  • Low-grade Ta, multifocal
  • High-grade Ta, ≤3 cm (solitary tumor)

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 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 participants with low- to intermediate-risk NMIBC.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Two-Arm, Single-Dose, Double-Blind, Placebo-CONtrolled Phase 3 Study of Intravesical Qapzola™ (Apaziquone) as a Chemotherapy Adjuvant to TransUrEthral Resection of Bladder Tumors in Patients With Low- to Intermediate-Risk Non-Muscle Invasive Bladder Cancer (CONQUER)
Actual Study Start Date : August 4, 2017
Actual Primary Completion Date : September 26, 2019
Actual Study Completion Date : September 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Qapzola
Participants were randomized to receive a single dose of Qapzola 8 mg by intravesical administration into the bladder at 60 ± 30 minutes post transurethral resection of bladder tumor (TURBT) on Day 1 via an indwelling 100% Silicone Foley catheter and retained in the bladder for 60 ± 5 minutes.
Drug: Qapzola
Qapzola administered by the intravesical route.

Placebo Comparator: Placebo
Participants were randomized to receive a single dose of Qapzole-matching placebo by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter and retained in the bladder for 60 ± 5 minutes.
Drug: Placebo
Qapzole-matching placebo administered by the intravesical route.




Primary Outcome Measures :
  1. Time to Recurrence [ Time Frame: From randomization to date of histologically confirmed recurrence of bladder cancer (up to 2.1 years) ]
    Time from randomization to the date of histologically confirmed recurrence of bladder cancer. A recurrence was defined as any pathologically confirmed disease of ≥Ta tumor histology or carcinoma in situ (CIS) post-treatment.


Secondary Outcome Measures :
  1. 2-Year Recurrence Rate [ Time Frame: 2 years ]
    The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before Year 2. A recurrence was defined as any pathologically confirmed disease of ≥Ta tumor histology or CIS post-treatment.

  2. Time to Disease Progression [ Time Frame: From randomization to first disease progression (up to 2.1 years) ]
    Time to disease progression was defined as the time from randomization to the first disease progression. The development of T2 or greater disease was only included in the assessment of time to disease progression.

  3. Number of Participants With Treatment-emergent Adverse Event (TEAE), Treatment-related Adverse Events, Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation, TEAEs of Special Interest, and Death [ Time Frame: Up to 2.1 years ]
    An AE was untoward medical occurrence in a participant who had study drug without possibility of causal relationship. TEAEs: AEs that occurred from dose of treatment until 35 days after study drug administration. Treatment-related AEs included TEAEs with relationship to study treatment (possible, probable, definite/missing). SAE was AE resulting in: death; initial/prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly. TEAEs of special interest were AEs of grade ≥3 dysuria and hematuria per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade ≥3 hematuria included gross hematuria; transfusion, hospitalization indicated; elective endoscopy, radiologic or operative intervention indicated; limiting self-care activities of daily living (ADL), life-threatening events/death. Grade ≥3 dysuria included severe pain; pain/analgesics severely interfering with ADL and disabling.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. Participant must have had 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 papillary urothelial neoplasm of low malignant potential (PUNLMP).
  2. Participant was willing to give written informed consent and was able to adhere to dosing and visit schedules, and meet all study requirements.
  3. Participant was at least 18 years of age and <90 years of age at the time Informed Consent is signed.
  4. Participant was willing to practice two forms of contraception, one of which must have been a barrier method, from study entry until at least 35 days after study treatment. Participants surgically sterilized or who were postmenopausal for at least 1 year (defined as more than 12 months since last menses) did not require contraception.
  5. Females of childbearing potential had a negative pregnancy test within 30 days prior to randomization. Females who were postmenopausal for at least 1 year (defined as more than 12 months since last menses) or were surgically sterilized did not require this test.

Exclusion Criteria:

  1. Participant had 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. Participant had used any investigational drugs, biologics (vaccines, antibodies), or devices within 30 days prior to study treatment or had plans to use any of these during the course of the study.
  3. Participant had received any pelvic radiotherapy (including external beam and/or brachytherapy).
  4. Participant had a history of allergy to red color food dye or any other component of Qapzola, placebo, or their diluents.
  5. Participant had a surgical procedure 4 weeks prior to TURBT or had other surgical procedures performed at the time of TURBT or within 4 weeks after TURBT.
  6. Participant had 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. Participant had an active uncontrolled infection, including a urinary tract infection, underlying medical condition, or other serious illness that would impair the ability of the participant to receive study treatment or undergo study procedures.
  8. Participant had a bleeding disorder or a screening platelet count <100×10^9/per liter (L), or required continuous anticoagulation or bridging anticoagulation during the procedure.
  9. Participant had a hemoglobin value <10 grams per deciliter (g/dL) at Screening.
  10. Participant had confirmed extravesical urothelial disease (upper tract and urethral including prostatic urethral).
  11. Participant had 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. Participant had received any previous intravesical therapy for bladder cancer- chemotherapy, immunotherapy, or previous exposure to Qapzola in the previous 3 years.
  13. Participant had a tumor in the bladder diverticulum.
  14. Participant had a history of interstitial cystitis.
  15. Participant was 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


Locations
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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
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Study Director: Shanta Chawla, MD Spectrum Pharmaceuticals, Inc
  Study Documents (Full-Text)

Documents provided by Spectrum Pharmaceuticals, Inc:
Study Protocol  [PDF] December 22, 2016
Statistical Analysis Plan  [PDF] May 30, 2019

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Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT03224182    
Other Study ID Numbers: SPI-QAP-306
First Posted: July 21, 2017    Key Record Dates
Results First Posted: September 28, 2021
Last Update Posted: September 28, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Apaziquone
Antineoplastic Agents