A Study of the Safety, Tolerability and Effectiveness of Hydroxychloroquine and Itraconazole in Platinum-resistant Epithelial Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT03081702|
Recruitment Status : Recruiting
First Posted : March 16, 2017
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Platinum-resistant Epithelial Ovarian Cancer||Drug: Hydroxychloroquine Drug: Itraconazole||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||July 25, 2017|
|Estimated Primary Completion Date :||May 1, 2022|
|Estimated Study Completion Date :||October 1, 2022|
U.S. FDA Resources
Experimental: Hydroxychloroquine and Itraconazole
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.Drug: Itraconazole
Itraconazole is approved and used for the treatment of certain systemic fungal infections.
- Maximum tolerated dose of hydroxychloroquine [ Time Frame: 5 years ]Highest dose of hydroxychloroquine that is safe and tolerable that can be given in combination with itraconazole.
- Median progression-free survival [ Time Frame: 5 years ]Median duration of time from start of treatment to time of progression or death.
- Overall response rate [ Time Frame: 5 years ]Proportion of patients achieving complete response or partial response.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081702
|Contact: Stephanie Lheureux, M.D.||firstname.lastname@example.org|
|Contact: Smitha Udagani||416-946-4501 ext email@example.com|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Stephanie Lheureux, M.D. 416-946-2818|
|Principal Investigator:||Stephanie Lheureux, M.D.||Princess Margaret Cancer Centre|