NCT01469221

A Phase 3 International, Double-Bind Trial Evaluating Efficacy and Safety of Multiple Instillations of Intravesical Apaziquone vs. Placebo in Patients With Low-Intermediate Risk Non-Muscle Invasive Bladder Cancer (NMIBC)

Terminated Phase 3 Results posted Last updated 13 December 2017

What this trial tests

Phase 3 trial testing Apaziquone in Bladder Cancer in 47 participants. Terminated before completion.

Timeline

1 January 2012

Primary endpoint
1 April 2013

1 April 2013

Quick facts

Lead sponsor	Spectrum Pharmaceuticals, Inc
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	47
Start date	1 January 2012
Primary completion	1 April 2013
Estimated completion	1 April 2013
Sites	29 locations across United States, Czechia, Poland, Slovakia

Drugs / interventions tested

• Apaziquone — full drug profile →
• Placebo

Conditions studied

• Bladder Cancer — all drugs for Bladder Cancer →

Sponsor

Spectrum Pharmaceuticals, Inc — full company profile →

Who can join

18 and older, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Time to Recurrence
  Time frame: 24 Months
  Time from randomization to the date of first histologically confirmed recurrence of bladder cancer

Sponsor's own description

This is an international, multicenter, double-blind, placebo-controlled, randomized study. All eligible patients entering the open label phase of the study will receive a single immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral resection-bladder tumor (TURBT). Following Central Pathology review of histology and Double Blind Phase qualification, patients with confirmed eligibility will be randomized to receive either 6 weekly intravesical instillations of apaziquone or matching placebo and undergo cystoscopic and safety assessments every 3 months for 24 months. Patients with histologic evidence of recurrent disease during the study will be treated according to current treatment guidelines or local standard of care. Safety and efficacy assessments will be performed at 3 month intervals for all randomized patients throughout the study. Patients who receive single dose of apaziquone immediately following TURBT and are not eligible for randomization will be followed for 3 months by cystoscopic exam and safety assessments.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Molecular Pathways: Hypoxia-Activated Prodrugs in Cancer Therapy.
   Baran N, Konopleva M. · · 2017 · cited 105× · PMID 28137923 · DOI 10.1158/1078-0432.ccr-16-0895
2. Progress toward overcoming hypoxia-induced resistance to solid tumor therapy.
   Karakashev SV, Reginato MJ. · · 2015 · cited 70× · PMID 26316817 · DOI 10.2147/cmar.s58285
3. Hypoxia-induced therapy resistance: Available hypoxia-targeting strategies and current advances in head and neck cancer.
   Codony VL, Tavassoli M. · · 2021 · cited 53× · PMID 33465746 · DOI 10.1016/j.tranon.2021.101017
4. Targeted therapies in urothelial carcinoma.
   Ghosh M, Brancato SJ, Agarwal PK, Apolo AB. · · 2014 · cited 37× · PMID 24685646 · DOI 10.1097/cco.0000000000000064
5. Hypoxia within the glioblastoma tumor microenvironment: a master saboteur of novel treatments.
   Feldman L. · · 2024 · cited 36× · PMID 38994360 · DOI 10.3389/fimmu.2024.1384249
6. New therapeutic targets in the management of urothelial carcinoma of the bladder.
   Sverrisson EF, Espiritu PN, Spiess PE. · · 2013 · cited 5× · PMID 24400235 · DOI 10.2147/rru.s29131