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

NCT02563561 | Terminated Phase 3 Results DMC

• 1 other identifier: SPI-EOQ-13-305
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 3, randomized, multicenter, multi-arm, placebo-controlled, double-blind study of apaziquone in participants with ≤4 non-muscle invasive bladder cancer (NMIBC), ≤3.5 centimeters (cm) in diameter, all of which must had been fully resected at TURBT. In addition to Screening, participants underwent an assessment of urothelial carcinoma of the bladder via cystoscopy for clinically apparent tumor Ta, G1-G2. Following TURBT on Day 1, eligible participants were 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 was to evaluate the Time to Recurrence with either a one instillation of 4 mg apaziquone or two instillations of 4 milligram (mg) apaziquone relative to placebo instillation following TURBT in a participant with NMIBC who received TURBT.

Conditions

Bladder Cancer

Keywords

Bladder Cancer; Non-muscle invasive bladder cancer; Apaziquone; TURBT; Stage Ta, G1-G2

Outcome Measures

Primary Outcomes (1)

• Time to Recurrence

  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.

  From randomization to the date of first histologically confirmed recurrence of bladder cancer (up to 1.5 years)

Secondary Outcomes (4)

• 2-Year Recurrence Rate

  2 years

• 1-Year Recurrence Rate

  1 year

• Time to Progression

  From randomization to the date of first disease progression (up to 1.5 years)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and Death

  Up to 1.5 Years

Study Arms (3)

1 Dose Apaziquone

EXPERIMENTAL

Participants were randomized to receive first dose of 4 mg of apaziquone 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. Followed by second dose of placebo by intravesical administration via an indwelling catheter on Day 15 (±5 days).

Drug: Apaziquone; Other: Placebo

2 Dose Apaziquone

EXPERIMENTAL

Participants were randomized to receive first dose of 4 mg of apaziquone by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of 4 mg of apaziquone by intravesical administration via an indwelling catheter on Day 15 (±5 days).

Drug: Apaziquone

Placebo

PLACEBO COMPARATOR

Participants were randomized to receive first dose of matching placebo by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of matching placebo by intravesical administration via an indwelling catheter on Day 15 (±5 days).

Other: Placebo

Interventions

Apaziquone DRUG

One dose of apaziquone administered by intravesical administration

Also known as: EOquin

1 Dose Apaziquone; 2 Dose Apaziquone

Placebo OTHER

Matching placebo (containing 12 mg FD\&C red #40, 15 mg sodium chloride, and 10 mg mannitol was supplied in identical appearing vials) by intravesical administration.

1 Dose Apaziquone; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Participant had an active concurrent malignancy/life-threatening disease. If there was a history of prior malignancies/life-threatening diseases, the participant was to be disease-free for at least 5 years. Participant with other prior malignancies less than 5 years before study entry could have still been enrolled if they had received treatment resulting in complete resolution of the cancer and currently had no clinical, radiologic, or laboratory evidence of active or recurrent disease.
• Participant had positive urine cytology for malignancy at Screening.
• 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 protocol treatment.
• Participant had used any investigational drugs, biologics, or devices within 30 days prior to study treatment or planned to use any of these during the course of the study.
• Participant had any prior intravesical chemotherapy, immunotherapy, or previous exposure to apaziquone.
• Participant had 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).
• Participant had a tumor in a bladder diverticulum.
• Participant had received any pelvic radiotherapy (including external beam and/or brachytherapy.)
• Participant had a bleeding disorder or a screening platelet count \<100×10\^9/L.

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (1)

The Urology Center of Colorado

Denver, Colorado, 80211, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Interventions

apaziquone

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Limitations and Caveats

The study was terminated as per Sponsor's decision.

Results Point of Contact

• Title: Shanta Chawla
• Organization: Spectrum Pharmaceuticals, Inc. Research and Development Office 157 Technology Drive Irvine, CA 92618

shanta.chawla@sppirx.com

(949) 788-6700

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: September 30, 2015
• Study Start: October 9, 2015
• Primary Completion: March 10, 2017
• Study Completion: March 10, 2017
• Last Updated: October 27, 2021
• Results First Posted: September 27, 2021

Record last verified: 2021-10

Locations

US (1)