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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00143653 | Other Identifier | Medical University of South Carolina |
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This is a single-institution, single-arm study with a safety lead-in to determine if previously established safe doses of autophagy drugs, hydroxychloroquine (HCQ) and nelfinavir mesylate (NFV) will benefit ovarian cancer patients in a maintenance setting. Patients will receive the two study drugs HCQ and NFV in combination with maintenance bevacizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxychloroquine+Nelfinavir+Bevacizumab | Experimental | Subjects will take Hydroxychloroquine 3x 200 milligram tablets twice daily Subjects will take Nelfinavir 2x 625 milligram tablets twice daily Subjects will be administered Bevacizumab IV 15 milligram/kilogram every 3 weeks. DLT Period 21 Days (1 Cycle) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | 3 x 200 milligram tablets twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of combination of study drugs | To measure the safety of HCQ + NFV in combination with standard-of-care maintenance bevacizumab in patients with high-grade serous ovarian cancer. DLT (dose limiting toxicity) is the standard endpoint in evaluating safety at this study phase. Will monitor adverse events per CTCAE v5.0. | 6 months |
| Evaluation of Anti Tumor Activity | Evaluate the anti-tumor activity of HCQ + NFV in combination with standard-of-care maintenance bevacizumab in patients with high-grade serous ovarian cancer. Measured by 6-month progression-free survival rate, a composite metric based on CA 125 and radiographic imaging. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in CA125 | changes in CA125 in patients treated with HCQ + NFV in combination with standard-of-care maintenance bevacizumab | 6 months |
| Changes in Quality of Life | To document the change in QOL (via disease-specific FACT questionnaire, composite score) in patients treated with HCQ + NFV in combination with standard-of-care maintenance bevacizumab |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brian Orr | Contact | 843-792-9300 | orrb@musc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| D019888 | Nelfinavir |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Nelfinavir | Drug | 2x 625 milligram tablets twice daily |
|
| Bevacizumab | Drug | IV 15 milligram/kilogram every 3 weeks |
|
| 6 months |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D007546 | Isoquinolines |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |