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The purpose of this Phase 2 portion of the study is to use the dose and schedule of RX-5902 identified in the phase 1 to treat subjects with triple negative breast cancer.
In this dose-finding, open-label, single-agent study of RX-5902, subjects will be treated for up to 6 cycles of therapy. RX-5902 will be administered orally daily for 3 weeks followed by 1 week of rest in each cycle. All subjects will be followed for at least 30 days after the last dose of study agent for safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RX-5902 | Experimental | RX-5902 will be taken daily for 4 weeks in each 4 week cycle. Subjects will be fasting for 8 hours before and food may be ingested approximately 3 hours after the dose has been administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RX-5902 | Drug | escalating doses (mg) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting toxicities (DLTs) (Phase 1) | after 4 weeks of treatment with RX-5902 | |
| Progression free survival rate and/or overall clinical response rate (Phase 2) | 16 weeks of treatment with RX-5902 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) of RX-5902 | predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8 hrs after the first dose | |
| Changes in tumor size mm | baseline and 24 weeks | |
| Measure | Description | Time Frame |
|---|---|---|
| phosphorylated P68 by IHC | baseline and 8 weeks | |
| Tumor burden response (Phase 2) | Baseline and at 4, 8, 12, 16 and 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ely Benaim, MD | Rexahn Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rexahn site | Tucson | Arizona | 85724 | United States | ||
| Rexahn Site |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 15, 2020 | |
| Reset | Jul 2, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 15, 2020 | Jul 2, 2020 |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| C000606305 | RX-5902 |
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| Time to progression (Phase 2) |
| Baseline and at 4, 8, 12, 16 and 24 weeks |
| Duration of response (Phase 2) | Baseline and at 4, 8, 12, 16 and 24 weeks |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 6 months |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Rexahn site | Chicago | Illinois | 60637 | United States |
| Rexahn Site | Detroit | Michigan | 48202 | United States |
| Rexahn Site | Hackensack | New Jersey | 07601 | United States |
| Rexahn Site | New York | New York | 10065 | United States |
| Rexahn Site | Greenville | South Carolina | 29605 | United States |
| Rexahn site | Arlington | Virginia | 22031 | United States |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |