A Phase I/II Trial Investigating the Tolerability, Toxicity and Efficacy of Hydroxychloroquine and Itraconazole in Patients With Advanced Platinum-resistant Epithelial Ovarian Cancer (EOC) (HYDRA-1 Study)
Sponsor study identifier
interventional
13
1 country
1
Study Start
July 25, 2017
Actual (reported)Primary Completion
August 27, 2019
Actual (reported)Study Completion
August 27, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 27, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 10, 2017
Actual (reported)March 16, 2017
Actual (reported)July 25, 2017
Actual (reported)August 27, 2019
Actual (reported)August 27, 2019
Actual (reported)Maximum tolerated dose of hydroxychloroquine
Highest dose of hydroxychloroquine that is safe and tolerable that can be given in combination with itraconazole.
5 years
Median progression-free survival
5 years
Overall response rate
5 years
Hydroxychloroquine, orally (by mouth), at a dose of 100 mg, 200 mg, 400 mg, or 600 mg, twice a day, every day. Itraconazole, orally (by mouth) at 300 mg, twice a day, every day.
Hydroxychloroquine is approved/used for the treatment of rheumatoid arthritis, and discoid and systemic lupus erythematosus, as well as suppressive treatment and treatment of acute attacks of malaria.
Itraconazole is approved and used for the treatment of certain systemic fungal infections.
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
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.
Stephanie Lheureux, M.D.
Princess Margaret Cancer Centre
13 participants (actual enrollment reported by the registry).
First Submitted
March 10, 2017
First Posted
March 16, 2017
Study Start
July 25, 2017
Actual (reported)Primary Completion
CPI-613 and Hydroxychloroquine for Patients With High Risk Myelodysplastic Syndrome
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
August 27, 2019
Actual (reported)Study Completion
August 27, 2019
Actual (reported)Last Updated
April 2, 2021
Record last verified: 2021-04
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Source: ClinicalTrials.gov.
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