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A Study of the Safety, Tolerability and Effectiveness of Hydroxychloroquine and Itraconazole in Platinum-resistant Epithelial Ovarian Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2017 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT03081702
First received: March 10, 2017
Last updated: NA
Last verified: March 2017
History: No changes posted
  Purpose
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.

Condition Intervention Phase
Platinum-resistant Epithelial Ovarian Cancer
Drug: Hydroxychloroquine
Drug: Itraconazole
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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)

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 52
Anticipated Study Start Date: May 1, 2017
Estimated Study Completion Date: October 1, 2022
Estimated Primary Completion Date: May 1, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03081702

Contacts
Contact: Stephanie Lheureux, M.D. 416-946-2818

Locations
Canada, Ontario
Princess Margaret Cancer Centre Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Stephanie Lheureux, M.D.    416-946-2818      
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Stephanie Lheureux, M.D. Princess Margaret Cancer Centre
  More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03081702     History of Changes
Other Study ID Numbers: HYDRA-1
Study First Received: March 10, 2017
Last Updated: March 10, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Itraconazole
Hydroxyitraconazole
Hydroxychloroquine
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 25, 2017