A Study of the Safety, Tolerability and Effectiveness of Hydroxychloroquine and Itraconazole in Platinum-resistant Epithelial Ovarian Cancer

Phase 1/2 Completed 13 enrolled University Health Network, Toronto

NaSingle-groupOpen-labelTreatment

Summary

This is a phase I/II study to find the highest dose of hydroxychloroquine that can be given safely with itraconazole in patients with advanced platinum-resistant epithelial ovarian cancer. The study will also determine the safety, tolerability, and initially determine whether the combination is useful in the treatment of patients with advanced platinum-resistant epithelial ovarian cancer.

Timeline

Start: 2017-07-25
Primary completion: 2019-08-27
Completion: 2019-08-27

Publications

Marastoni S, Madariaga A, Pesic A, Nair SN, Li ZJ, Shalev Z, Ketela T, Colombo I, Mandilaras V, Cabanero M, Bruce JP, Li X, Garg S, Wang L, Chen EX, Gill S, Dhani NC, Zhang W, Pintilie M, Bowering V, Koritzinsky M, Rottapel R, Wouters BG, Oza AM, Joshua AM, Lheureux S. Repurposing Itraconazole and Hydroxychloroquine to Target Lysosomal Homeostasis in Epithelial Ovarian Cancer. Cancer Res Commun. 2022 May 4;2(5):293-306. doi: 10.1158/2767-9764.CRC-22-0037. eCollection 2022 May.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hydroxychloroquine	Small molecule	100 mg	Oral
Subject	Hydroxychloroquine	Small molecule	200 mg	Oral
Subject	Hydroxychloroquine	Small molecule	400 mg	Oral
Subject	Hydroxychloroquine	Small molecule	600 mg	Oral
Subject	Itraconazole	Small molecule	300 mg	Oral

Indications

No indication recorded.