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 :
Active, not recruiting
First Posted : March 16, 2017
Last Update Posted : October 28, 2019
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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 |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
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. |
Drug: Hydroxychloroquine
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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Aged 18 years or older.
- Histologically or cytologically confirmed epithelial ovarian cancer.
- Platinum-resistant or refractory disease defined as a radiological or clinical progression less than six months after having finished platinum-based chemotherapy.
- ECOG performance status equal to or less than 1.
- Have clinically or radiographically documented measurable disease.
- All systemic therapy must have been completed 4 weeks or greater prior to enrollment with radiologic evidence of radiological disease progression.
- Life expectancy should be more than 3 months.
- Receiving any medications or substances that are inhibitors or inducers of CYP3A4 are ineligible.
- Acceptable laboratory requirements within 7 days prior to enrollment
- Treated and asymptomatic brain metastases are eligible. Patients that received palliative radiation (for brain metastases) are eligible if they have been asymptomatic for at least 2 weeks with use of maintenance steroid therapy, and last received radiation at least 4 weeks prior to start of therapy.
- Have the ability to understand and willing to sign a written informed consent document.
Exclusion Criteria:
- Have not recovered (grade 1 or less) from adverse events related to previous treatments are excluded with the exception of alopecia and lymphopenia. Peripheral sensory neuropathy must be at grade 2 or less.
- Have any other prior malignancy from which the patient has been disease free for less than 3 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of any site or any other cancer.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to itraconazole or hydroxychloroquine.
- Known G6PD deficiency due to the risk of hemolytic anemia with the use of hydroxychloroquine.
- Known retinopathy due to the risk of worsening retinopathy with hydroxychloroquine.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic or asymptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Chronic Hepatitis B or hepatitis C infections should be excluded because of potential effects on hepatic function and/ or drug interactions.
- Human Immunodeficiency Virus (HIV) infection.
- Already have a clinical indication for treatment with itraconazole (e.g. chronic candidiasis or other fungal infection) or hydroxychloroquine (e.g. lupus).

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
Canada, Ontario | |
Princess Margaret Cancer Centre | |
Toronto, Ontario, Canada, M5G 2M9 |
Principal Investigator: | Stephanie Lheureux, M.D. | Princess Margaret Cancer Centre |
Responsible Party: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT03081702 |
Other Study ID Numbers: |
HYDRA-1 |
First Posted: | March 16, 2017 Key Record Dates |
Last Update Posted: | October 28, 2019 |
Last Verified: | October 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Hydroxychloroquine |
Itraconazole Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents Antifungal Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |