Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied in oncology for lung cancer, breast cancer, and metastatic cancer. It has been evaluated in clinical trials as a radiosensitizer, intended to enhance the effects of radiation therapy in patients with these conditions.
Efaproxiral is being developed by Assertio Holdings, Inc., a pharmaceutical company traded on the NASDAQ under the ticker symbol ASRT. The company has sponsored clinical trials of Efaproxiral in oncology indications.
Efaproxiral has completed Phase 3 clinical trials, including studies in metastatic cancer and breast cancer with brain metastases. It remains an investigational drug and has not been approved by the FDA for any indication.
Efaproxiral has been studied in three completed trials: NCT00004202, a Phase 2 study in stage III non-small cell lung cancer; NCT00005887, a Phase 3 study in brain metastases; and NCT00083304, a Phase 3 study in women with brain metastases from breast cancer.
Yes, Efaproxiral is also known as RSR13. Clinical trial records refer to the drug as RSR13, and it is the same investigational compound being developed by Assertio Holdings, Inc.