It will continue to recruit 64 participants who failed to respond to platinum-based chemotherapy.
The trial “is a major step in the expansion of the NuCana product pipeline and advances our strategy of rapidly developing our ProTides to benefit cancer patients globally,” Hugh Griffith, NuCana’s CEO, said in a press release. “We are grateful to the patients and clinicians [doctors] who are making this study possible.”
NuCana designed Acelarin to overcome the mechanisms that cancer cells use to resist Gemzar. It is based on the structures of two chemotherapy agents, gemcitabine and 5-fluorouracil. The idea is that a combination of the agents will be more effective than either alone.
“Acelarin’s ability to overcome key cancer cell resistance mechanisms resulting in significantly greater levels of the active anti-cancer metabolite differentiates it from other treatment approaches,” said Dr. Bradley J. Monk, director of the Division of Gynecologic Oncology at Creighton University School of Medicine in Arizona. He is co-chief investigator of the Phase 2 trial.
In a Phase 1 study (NCT01621854), Acelarin stopped the progression of advanced solid tumors in 78 percent of the 49 patients treated. Patients also tolerated the drug well.
Acelerin was even better in patients whose gynecological cancer had failed to respond to treatment or had returned. Ninety-three percent achieved a stable disease.
In addition, 96 percent of patients with ovarian cancer that had returned achieved at least a stable disease with a combination of Acelerin and Micromedex’s Paraplatin (carboplatin), a Phase 1b trial (NCT02303912) showed. And 36 percent of patients saw a reduction in their tumor.
NuCana designed the Phase 2 PRO-105 trial (NCT03146663) to test Acelarin in ovarian cancer patients who have received at least three lines of platinum-based chemotherapy.
It will be conducting the study at nine clinical sites in the United States and at the Edinburgh Cancer Research Center in Britain.
The trial will be divided in two parts. In part one, 20 patients will receive one of two Acelarin doses on days 1, 8, and 15. In the second part, an additional 24 patients will receive what researchers determined to be the best dose until their disease progresses.
The main goal of the study is to see how many people respond to treatment. Secondary measures include the duration of patients’ response, the time it takes for their disease to progress, their overall survival rate, and the therapy’s safety. NuCana expects to announce preliminary results of the trial in 2018.
“Acelarin has shown meaningful clinical activity in advanced recurrent ovarian cancer and has been well-tolerated in clinical studies to date,” said Dr. Charlie Gourley, a University of Edinburgh professor who is the other co-chief investigator of the study. “We are pleased to be a part of this important clinical study.”