Ainhoa Madariaga, MD, discusses the data from the phase 1/2 HYDRA-01 trial looking at hydroxychloroquine and itraconazole in patients with advanced platinum-resistant epithelial ovarian cancer.
Ainhoa Madariaga, MD, a medical oncologist and clinical research fellow at Princess Margaret Cancer Centre, discusses the data from the phase 1/2 HYDRA-01 trial (NCT03081702) looking at hydroxychloroquine and itraconazole in patients with advanced platinum-resistant epithelial ovarian cancer.
In terms of safety, there was 1 dose-limiting toxicity of hypertension at the second dose level, but investigators were able to manage it. Madariaga says they found mostly grade 1 and 2 gastrointestinal adverse events such as nausea and diarrhea. There was 1 patient in the higher dose level who experienced grade 3 hypokalemia and grade 4 QTc prolongation, which was also managed.
The combination of hydroxychloroquine and itraconazole had anticancer effects in 1 patient who achieved stable disease; none of the other patients had objective responses.
An important part of the trial were the correlative studies, according to Madariaga. There were pre- and on-treatment biopsies to assess changes in the patients’ pathways and the investigators performed an immunohistochemistry analysis of autophagy proteins and lysosomal markers in these patients. They found an increase of those markers in 3 patients, but there was no correlation to their outcomes. Patients also had RNA sequencing in their sequential biopsies to assess relevant pathways and found no significant changes in pre- and on-treatment biopsies.