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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxychloroquine and Itraconazole | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose of hydroxychloroquine | Highest dose of hydroxychloroquine that is safe and tolerable that can be given in combination with itraconazole. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Median progression-free survival | Median duration of time from start of treatment to time of progression or death. | 5 years |
| Overall response rate | Proportion of patients achieving complete response or partial response. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Lheureux, M.D. | Princess Margaret Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36875717 | Derived | Marastoni S, Madariaga A, Pesic A, Nair SN, Li ZJ, Shalev Z, Ketela T, Colombo I, Mandilaras V, Cabanero M, Bruce JP, Li X, Garg S, Wang L, Chen EX, Gill S, Dhani NC, Zhang W, Pintilie M, Bowering V, Koritzinsky M, Rottapel R, Wouters BG, Oza AM, Joshua AM, Lheureux S. Repurposing Itraconazole and Hydroxychloroquine to Target Lysosomal Homeostasis in Epithelial Ovarian Cancer. Cancer Res Commun. 2022 May 4;2(5):293-306. doi: 10.1158/2767-9764.CRC-22-0037. eCollection 2022 May. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 9, 2023 | |
| Reset | Feb 9, 2024 | |
| Release | Mar 22, 2024 |
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| Itraconazole | Drug | Itraconazole is approved and used for the treatment of certain systemic fungal infections. |
|
| 5 years |
| Reset | Aug 16, 2024 |
| Release | Aug 30, 2024 |
| Reset | Nov 13, 2024 |
| Release | Jul 6, 2026 |
| Reset | Jul 6, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 9, 2023 | Feb 9, 2024 | |||
| Mar 22, 2024 | Aug 16, 2024 | |||
| Aug 30, 2024 | Nov 13, 2024 | |||
| Jul 6, 2026 | Jul 6, 2026 |
| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D010879 | Piperazines |
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