NCT01410565

A Phase 3 International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the 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 12 December 2016

What this trial tests

Phase 3 trial testing Apaziquone in Bladder Cancer in 66 participants. Terminated before completion.

Timeline

1 July 2011

Primary endpoint
1 March 2014

1 March 2014

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	66
Start date	1 July 2011
Primary completion	1 March 2014
Estimated completion	1 March 2014
Sites	47 locations across United States, Canada

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: Recurrence of cancer in the bladder during 24 months of follow-up
  Time to recurrence is the time from randomization to the date of first histologically confirmed recurrence of bladder cancer (for eligible patients with Low- intermediate risk NMIBC, who had undergone TURBT followed by, a single instillation of apaziquone immediately post TURBT and multiple instillations of apaziquone or placebo).

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 from randomization. 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

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

1. Targeting the hypoxic fraction of tumours using hypoxia-activated prodrugs.
   Phillips RM. · · 2016 · cited 155× · PMID 26811177 · DOI 10.1007/s00280-015-2920-7
2. Management of carcinoma in situ of the bladder: best practice and recent developments.
   Tang DH, Chang SS. · · 2015 · cited 42× · PMID 26622320 · DOI 10.1177/1756287215599694
3. Remembering the Host in Tuberculosis Drug Development.
   Frank DJ, Horne DJ, Dutta NK, Shaku MT, et al · · 2019 · cited 34× · PMID 30590592 · DOI 10.1093/infdis/jiy712