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Also known as RSR13
efaproxiral · 3 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| Efaproxiral + WBRT + Supplemental Oxygen | EXPERIMENTAL | - |
| WBRT + Supplemental Oxygen | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Efaproxiral | DRUG | 75 mg/kg, administered over 30 minutes via a central venous access device (CVAD). Administered 30 minutes prior to the start of whole brain radiation therapy (WBRT) on each WBRT treatment day for 10 days. |
| Whole Brain Radiation Therapy (WBRT) | RADIATION | 3.0 Gy per day for 10 days (30.0 Gy total) of WBRT. |
| Supplemental Oxygen | OTHER | 4 L/minute by nasal cannula. Administered at least 35 minutes prior to WBRT, during WBRT and until 15 minutes after completion of WBRT on all WBRT treatment days. |
| radiation therapy | RADIATION | - |
| carboplatin | DRUG | - |
| chemotherapy | DRUG | - |
| paclitaxel | DRUG | - |
Inclusion Criteria: * Adult women with brain metastases from breast cancer * Minimum KPS of 70 Exclusion Criteria: * Previous treatment for brain metastases, including brain surgery and any form of radiation to the brain
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Efaproxiral is an investigational small molecule studied in oncology as a radiation sensitizing agent. It has been tested in breast cancer with brain metastases, metastatic cancer, and stage III non-small cell lung cancer, always in combination with radiation therapy or chemotherapy plus radiation. It is not approved and remains in clinical development.
Efaproxiral targets hemoglobin, specifically the HBA2, HBA1, and HBB subunits, and acts as a negative modulator of those proteins. By binding hemoglobin, it is designed to reduce hemoglobin oxygen affinity and increase the release of oxygen into hypoxic tumor tissue, which is the rationale for combining it with radiation therapy.
Efaproxiral is being developed by Assertio Holdings, Inc., which trades under the ticker ASRT. The company is the sponsor associated with the drug's clinical development program in oncology.
Efaproxiral is in Phase 3 development. It is investigational and has not been approved by the FDA. The Phase 3 program includes studies in brain metastases from breast cancer and in brain metastases from other metastatic cancers, with earlier Phase 2 work in stage III non-small cell lung cancer.
Efaproxiral has been studied in NCT00083304, a Phase 3 trial of whole brain radiation therapy with oxygen, with or without RSR13, in women with brain metastases from breast cancer, and in NCT00005887, a Phase 3 trial of radiation therapy with or without RSR13 in patients with brain metastases. NCT00004202 was a Phase 2 trial in stage III non-small cell lung cancer.
Yes, efaproxiral is also known as RSR13. The name RSR13 appears in the titles of its clinical trials, including the Phase 3 studies NCT00083304 and NCT00005887 and the Phase 2 study NCT00004202, so searches for either name refer to the same investigational agent.