The international, multicentre, randomised trial will evaluate the safety and efficacy of lucanthone administered in combination with temozolomide (TMZ) and radiation treatment.
Spectrum Pharmaceuticals chairman, president and chief executive officer Rajesh Shrotriya said the earlier-stage clinical findings for lucanthone included an impressive safety profile in earlier studies, supported by the track record of use of the agent in another indication.
"Additionally, we have seen early clinical evidence that lucanthone’s distinctive mechanism of action can help potentiate the activity of anti-cancer treatments, including radiotherapy," Shrotriya added.
The placebo-controlled study will enrol approximately 140 patients, who will be randomised in a 1:1 fashion to one of two groups including six-week treatment of focal radiation + TMZ + lucanthone (active arm) or focal radiation +TMZ + placebo (control arm).
The progression free survival (PFS) at nine months is the primary endpoint while PFS at one year and overall survival (OS) at one year are the secondary endpoints of the study.