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A Study of Intravesical Apaziquone as a Surgical Adjuvant in Patient Undergoing 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: NCT02563561
Recruitment Status : Active, not recruiting
First Posted : September 30, 2015
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Brief Summary:

This is a Phase 3, randomized, multicenter, multi-arm, placebo-controlled, double-blind study of apaziquone in patients with ≤4 non-muscle invasive bladder tumors, ≤3.5 cm in diameter, all of which must have been fully resected at TURBT.

In addition to Screening, patients will undergo an assessment of urothelial carcinoma of the bladder via cystoscopy for clinically apparent tumor Ta, G1-G2.

Following TURBT on Day 1, eligible patients will be randomized to one of three treatment arms in a 1:1:1 ratio:

Arm 1 : One dose of Apaziquone

Arm 2 : Two Doses of Apaziquone

Arm 3 : Placebo

Primary endpoint is to evaluate the Time to Recurrence with either a one instillation of 4 mg apaziquone or two instillations of 4 mg apaziquone relative to placebo instillation following TURBT in patients with non-muscle invasive bladder cancer (NMIBC) who receive transurethral resection bladder tumor (TURBT).


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

Detailed Description:

This is a Phase 3, randomized, multicenter, multi-arm, placebo-controlled, double-blind study of apaziquone in patients with ≤4 non-muscle invasive bladder tumors, ≤3.5 cm in diameter, all of which must have been fully resected at TURBT.

In addition to Screening, patients will undergo an assessment of urothelial carcinoma of the bladder via cystoscopy for clinically apparent tumor Ta, G1-G2.

Following TURBT on Day 1, eligible patients will be randomized to one of three treatment arms in a 1:1:1 ratio :

Arm 1 : One Dose of Apaziquone:

  • Day 1: administration of 4 mg of apaziquone 60±30 minutes post-TURBT
  • Day 15 (±5 days): administration of placebo

Arm 2 : Two Doses of Apaziquone :

  • Day 1 : administration of 4 mg of apaziquone 60±30 minutes post-TURBT
  • Day 15 (±5 days): administration of 4 mg of apaziquone

Arm 3: Placebo :

  • Day 1 : administration of placebo 60±30 minutes post-TURBT
  • Day 15 (±5 days) : administration of placebo

Once randomized, Day 1 study drug instillation will occur 60 ±30 minutes post TURBT. Patients will return on Day 15 (±5 days) for a second instillation unless their pathology results are available and show non Ta, G1-G2 histology; in the absence of local pathology results by the Day 15 visit, patients will receive a second instillation of study drug. All histology specimens will be reviewed by a local pathology laboratory and all clinical treatment decisions and study analyses will be based on the local pathology review. Patients whose pathology is other than Ta, G1-G2 will be followed for safety at Day 35 (±5 days) from the last dose of study drug and then discontinued from the study.

Patients with pathology confirmed Ta, G1-G2 disease will be followed according to the schedule below :

  • Cystoscopic examination and urine cytology every 90 days (±10 days) (calculated from date of TURBT) through 24 months for tumor recurrence and progression.
  • If at any time during the 24 month follow up period there is a tumor recurrence, the patient will continue on study with follow-up cystoscopic examination and urine cytology every 90 days (±10 days) (calculated from date of TURBT) through the end of 24 months. Patients with a recurrence are permitted to have a follow-up TURBT.
  • If at any time during the 24 month follow up period there is a tumor recurrence and/or patient is started on another therapy, the patient will be followed by telephone, for safety every 90 days (±10 days) (calculated from date of TURBT) through the end of 24 months.

Duration of Study: The duration of the study for each patient will be approximately 24 months including:

  • Screening Period : 30-days
  • Treatment Period : Day 1 and Day 15 (±5 days)
  • Safety and Follow-up Period: 24-months

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1869 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Multi-Arm, Randomized, Multi-Dose, Placebo-Controlled, Double-Blind, Phase 3 Study of Intravesical Apaziquone (EOquin®) as a Surgical Adjuvant in the Immediate Postoperative Period in Patients Undergoing TURBT
Study Start Date : September 2015
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Apaziquone and Placebo
One Dose of Apaziquone and One Dose of Placebo
Drug: Apaziquone
The first dose of either 4 mg/40 mL apaziquone or placebo will be administered by intravesical administration into the bladder at 60±30 minutes post TURBT (randomization date, Day 1) via an indwelling 100% Silicone Foley catheter. The second dose of either 4 mg/40 mL apaziquone or placebo will administered by intravesical administration via an indwelling catheter on Day 15 (±5 days).
Other Name: EOquin

Other: Placebo
Matching placebo containing 12 mg FD&C red #40, 15 mg sodium chloride, and 10 mg mannitol is supplied in identical appearing vials.

Experimental: Apaziquone and Apaziquone
Two Doses of Apaziquone
Drug: Apaziquone
The first dose of either 4 mg/40 mL apaziquone or placebo will be administered by intravesical administration into the bladder at 60±30 minutes post TURBT (randomization date, Day 1) via an indwelling 100% Silicone Foley catheter. The second dose of either 4 mg/40 mL apaziquone or placebo will administered by intravesical administration via an indwelling catheter on Day 15 (±5 days).
Other Name: EOquin

Placebo Comparator: Placebo and Placebo
Two Doses of Placebo
Other: Placebo
Matching placebo containing 12 mg FD&C red #40, 15 mg sodium chloride, and 10 mg mannitol is supplied in identical appearing vials.




Primary Outcome Measures :
  1. Time to Recurrence [ Time Frame: 2 Years ]
    To evaluate the Time to Recurrence with either a one instillation of 4 mg apaziquone or two instillations of 4 mg apaziquone relative to placebo instillation following TURBT in patients with non-muscle invasive bladder cancer (NMIBC) who receive transurethral resection bladder tumor (TURBT)


Secondary Outcome Measures :
  1. 2-Year Recurrence Rate [ Time Frame: 2 Years ]
    To evaluate the 2-Year Recurrence Rate with either one instillation of 4 mg apaziquone or two instillations of 4 mg apaziquone relative to placebo instillation following TURBT in patients with NMIBC who receive TURBT.

  2. 1-Year Recurrence Rate [ Time Frame: 1 Year ]
    To evaluate the 1-Year Recurrence Rate with either one instillation of 4 mg apaziquone or two instillations of 4 mg apaziquone relative to placebo instillation following TURBT in patients with NMIBC who receive TURBT.

  3. Time to progression [ Time Frame: 2 Years ]
    To evaluate the Time to Progression with either one instillation of 4 mg apaziquone or two instillations of 4 mg apaziquone relative to placebo instillation following TURBT in patients with NMIBC who receive TURBT

  4. Adverse Events [ Time Frame: 2 Years ]
    To evaluate the safety with either one instillation of 4 mg apaziquone or two instillations of 4 mg apaziquone relative to placebo instillation following TURBT in patients with NMIBC



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must have a diagnosis with urothelial carcinoma of the bladder with clinically apparent tumor Ta, G1-G2.
  2. Patient will have ≤4 tumors, none of which exceeds 3.5 cm in diameter.
  3. 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.
  4. Patient is at least 18 years of age at randomization.
  5. 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 the last dose of the study drug.
  6. 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 an active concurrent malignancy/life-threatening disease. If there is a history of prior malignancies/life-threatening diseases, the patient is to be disease free for at least 5 years. Patients with other prior malignancies less than 5 years before study entry may still be enrolled if they have received treatment resulting in complete resolution of the cancer and currently have no clinical, radiologic, or laboratory evidence of active or recurrent disease.
  2. Patient has positive urine cytology for malignancy at Screening.
  3. 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 protocol treatment.
  4. Patient has used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.
  5. Patient has had any prior intravesical chemotherapy, immunotherapy, or previous exposure to apaziquone.
  6. Patient has or has ever had

    • Upper tract Transitional Cell Carcinoma (TCC).
    • Urethral tumor (prostatic urethra included).
    • Any invasive bladder tumor known to be other than tumor Ta, G1-G2.
    • Any evidence of lymph node or distant metastasis.
    • Any bladder tumor with histology other than TCC.
    • Carcinoma in situ (CIS).
  7. Patient has a tumor in a bladder diverticulum.
  8. Patient has received any pelvic radiotherapy (including external beam and/or brachytherapy.)
  9. Patient has a bleeding disorder or a screening platelet count <100×109/L.
  10. Patient has screening hemoglobin <10 mg/dL.
  11. Patient has any unstable medical condition that would make it unsafe to undergo TURBT.
  12. Patient has a history of interstitial cystitis.
  13. Patient has a history of allergy to red color food dye.
  14. For patients with recurrent tumor, the patient had at least a 6-month cystoscopically-confirmed tumor-free interval between the last tumor recurrence and screening cystoscopic examination.
  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): NCT02563561


Locations
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United States, Colorado
The Urology Center of Colorado
Denver, Colorado, United States, 80211
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
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Study Director: Nawazish A Khan, MD Spectrum Pharmaceuticals, Inc
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Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02563561    
Other Study ID Numbers: SPI-EOQ-13-305
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Keywords provided by Spectrum Pharmaceuticals, Inc:
Bladder Cancer
Non-muscle invasive bladder cancer
Apaziquone
TURBT
Stage Ta, G1-G2
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