Deciphera Pharmaceuticals has started a Phase lll clinical study to evaluate the safety and efficacy of DCC-2618 for treating patients with advanced gastrointestinal stromal tumours (GIST).

The invictus randomised, double‑blind, placebo-controlled, international, multicentre trial also seeks to assess the tolerability of DCC-2618 compared to placebo in patients with advanced GIST whose previous therapies have included imatinib, sunitinib, and regorafenib.

Around 120 patients are expected to be included in the study and will be randomised 2:1 to receive either 150mg once-daily of DCC-2618 or placebo.

Primary efficacy endpoint of the trial is median progression-free survival (PFS) as determined by independent radiologic review using modified response evaluation criteria in solid tumours (RECIST).

“This pivotal Phase lll study could serve as the basis for an NDA, providing a much-needed therapeutic option for patients for whom there are no approved treatments.”

The trial’s secondary objectives will be determined by independent radiologic review using modified RECIST and include objective response rate (ORR), time to tumour-progression (TTP), and overall survival (OS).

Deciphera Pharmaceuticals president and CEO Michael Taylor said: “We expect to report top-line results in 2019 and, if successful, this pivotal Phase lll study could serve as the basis for a new drug application (NDA), providing a much-needed therapeutic option for these patients for whom there are no approved treatments.

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“We also plan to initiate a second Phase lll study later this year evaluating DCC-2618 in second-line GIST patients who have progressed or are intolerant to front-line therapy with imatinib.”

Deciphera added that its DCC-2618 solution is a pan-KIT and PDGFRα kinase switch-control inhibitor designed for treatment of KIT and/or PDGFRα-driven cancers, including gastrointestinal stromal tumours, glioblastoma multiforme, and systemic mastocytosis.