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NCT03081702

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

Completed Phase 1, PHASE2 Last updated 2 April 2021
What this trial tests

Phase 1, PHASE2 trial testing Hydroxychloroquine in Platinum-resistant Epithelial Ovarian Cancer in 13 participants. Completed in 27 August 2019.

Timeline
25 July 2017
Primary endpoint
27 August 2019
27 August 2019

Quick facts

Lead sponsorUniversity Health Network, Toronto
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment13
Start date25 July 2017
Primary completion27 August 2019
Estimated completion27 August 2019
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University Health Network, Toronto

Who can join

18 and older, female only, with Platinum-resistant Epithelial Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Paradigm Shift: A Comprehensive Review of Ovarian Cancer Management in an Era of Advancements.
    Tavares V, Marques IS, Melo IG, Assis J, et al · · 2024 · cited 85× · PMID 38339123 · DOI 10.3390/ijms25031845
  2. Chloroquine against malaria, cancers and viral diseases.
    Zhou W, Wang H, Yang Y, Chen ZS, et al · · 2020 · cited 85× · PMID 32947043 · DOI 10.1016/j.drudis.2020.09.010
  3. Regulation of Apoptosis by Autophagy to Enhance Cancer Therapy.
    Tompkins KD, Thorburn A. · · 2019 · cited 51× · PMID 31866785
  4. Repurposing non-oncology small-molecule drugs to improve cancer therapy: Current situation and future directions.
    Fu L, Jin W, Zhang J, Zhu L, et al · · 2022 · cited 47× · PMID 35256933 · DOI 10.1016/j.apsb.2021.09.006
  5. The Role of Smoothened-Dependent and -Independent Hedgehog Signaling Pathway in Tumorigenesis.
    Chai JY, Sugumar V, Alshawsh MA, Wong WF, et al · · 2021 · cited 24× · PMID 34572373 · DOI 10.3390/biomedicines9091188
  6. The role of autophagy in cancer: from molecular mechanism to therapeutic window.
    Jalali P, Shahmoradi A, Samii A, Mazloomnejad R, et al · · 2025 · cited 22× · PMID 40248706 · DOI 10.3389/fimmu.2025.1528230
  7. Inhibition of CAL27 Oral Squamous Carcinoma Cell by Targeting Hedgehog Pathway With Vismodegib or Itraconazole.
    Freitas RD, Dias RB, Vidal MTA, Valverde LF, et al · · 2020 · cited 17× · PMID 33312948 · DOI 10.3389/fonc.2020.563838
  8. Co-targeting of lysosome and mitophagy in cancer stem cells with chloroquine analogues and antibiotics.
    Al-Bari MAA. · · 2020 · cited 16× · PMID 32935427 · DOI 10.1111/jcmm.15879

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03081702.

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