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. Clinical trials have evaluated it in lung cancer, metastatic cancer, and breast cancer, specifically for patients with brain metastases from breast cancer. It is not approved and remains in clinical development.
Efaproxiral is a synthetic allosteric modifier of hemoglobin. It works by reducing hemoglobin's oxygen-binding affinity, which increases oxygen release to hypoxic tumor tissues, potentially enhancing the effectiveness of radiation therapy.
Efaproxiral is being developed by Assertio Holdings, Inc., a pharmaceutical company traded on NASDAQ under the ticker ASRT.
Efaproxiral has completed Phase 3 clinical trials. It is an investigational drug and has not been approved by regulatory authorities. Its development status is not currently active, as all listed trials are completed.
Efaproxiral has been studied in three completed trials. NCT00004202 was a Phase 2 trial in stage III non-small cell lung cancer. NCT00005887 was a Phase 3 trial in brain metastases. NCT00083304 was a Phase 3 trial in women with brain metastases from breast cancer, enrolling 368 participants.
Yes, Efaproxiral is also known as RSR13. In clinical trials, it was referred to by this alternative name, which may appear in older literature and study records.