Clinical Trials

Date: 2017-08-14

Type of information: Recruitment of the first patient

phase: 3

Announcement: recruitment of the first patient

Company: Spectrum Pharmaceuticals (USA - NV)

Product: Qapzola™ (apaziquone)

Action mechanism: Qapzola™ (apaziquone) is a novel drug activated by DT-diaphorase, an enzyme over-expressed in bladder cancer cells, to generate cytotoxic species leading to cell death.

Disease: non-muscle invasive bladder cancer

Therapeutic area: Cancer - Oncology

Country:

Trial details:

• In accordance with the SPA, the Phase 3 trial is a randomized, double-blind, placebo-controlled, multi-center trial that will enroll patients with low and intermediate risk NMIBC as per the American Urology Association (AUA) Guidelines. The new study design with a reduced sample size from 1557 to about 425 patients will significantly shorten the duration of this trial. The protocol includes a single instillation of Qapzola 60 ± 30 minute post-TURBT, to avoid inactivation of Qapzola by blood that is present after surgery. The patients will be randomized 2:1 to receive either 8 mg instillation of Qapzola or placebo post-TURBT. Following one instillation of study drug and a safety follow-up at Day 35, subsequent follow up visits will be conducted until tumor recurrence or end of study, whichever occurs first. The primary endpoint for this trial is Time to Recurrence.

Latest news: • On August 14, 2017, Spectrum Pharmaceuticals announced that the company has enrolled the first patient in a Phase 3 trial of Qapzola™, a potent tumor-activated drug being investigated for low and intermediate risk non-muscle invasive bladder cancer. Under the SPA, this trial will evaluate the intravesical use of Qapzola™ in patients with non-muscle invasive bladder cancer (NMIBC), as a single instillation 60 ± 30 minutes, following transurethral resection of the bladder tumor (TURBT).    

Is general: Yes