A Study of the Safety, Tolerability and Effectiveness of Hydroxychloroquine and Itraconazole in Platinum-resistant Epithelial Ovarian Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|