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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 April 2021 |
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Main ID: |
NCT03081702 |
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Date of registration:
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10/03/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of the Safety, Tolerability and Effectiveness of Hydroxychloroquine and Itraconazole in Platinum-resistant Epithelial Ovarian Cancer
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Scientific title:
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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) |
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Date of first enrolment:
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July 25, 2017 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03081702 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Canada
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Contacts
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Name:
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Stephanie Lheureux, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Princess Margaret Cancer Centre |
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Key inclusion & exclusion criteria
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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).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Platinum-resistant Epithelial Ovarian Cancer
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Intervention(s)
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Drug: Hydroxychloroquine
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Drug: Itraconazole
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Primary Outcome(s)
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Maximum tolerated dose of hydroxychloroquine
[Time Frame: 5 years]
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Secondary Outcome(s)
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Overall response rate
[Time Frame: 5 years]
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Median progression-free survival
[Time Frame: 5 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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