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Efaproxiral

Phase 3

Breast Cancer | Small molecule | Oncology |Assertio Holdings, Inc.|Last Updated: Aug 26, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment368

FDA Designations

No designations recorded

Clinical trial landscape

Efaproxiral · 3 trials · 4 indications

Phase 3 2Phase 2 1
NCT00083304Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast CancerBreast Cancer
COMPLETED368 Analytics
NCT00005887Radiation Therapy With or Without RSR13 in Treating Patients With Brain MetastasesMetastatic Cancer
COMPLETED- Analytics
PHASE3COMPLETED
Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer
Breast CancerUnlock trial analytics
PHASE3COMPLETED
Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases
Metastatic CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Survival
Measured from randomization until death due to any cause.

Secondary Endpoints

Response Rate in the Brain at 3 Months
Assessed at screening, 3 months after end of study treatment and at least 4 weeks after the 3-month scan.
Karnofsky Performance Status & Neurological Signs & Symptoms
Assessed at baseline, 1 month follow-up (FU) visit, 3 month FU visit, and 6 month FU visit.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Efaproxiral + WBRT + Supplemental OxygenEXPERIMENTAL -
WBRT + Supplemental OxygenACTIVE_COMPARATOR -

Interventions

NameTypeDescription
EfaproxiralDRUG75 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)RADIATION3.0 Gy per day for 10 days (30.0 Gy total) of WBRT.
Supplemental OxygenOTHER4 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 therapyRADIATION -
carboplatinDRUG -
chemotherapyDRUG -
paclitaxelDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites94

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

Countries:United StatesArgentinaAustriaBrazilCanadaChileCroatiaFranceGreeceHungaryItalyLithuaniaPeruSpainUnited KingdomAustraliaBelgiumGermany
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Competitive Landscape -Breast Cancer 402 trials

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Frequently asked questions about Efaproxiral

What is Efaproxiral used for?

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.

Who makes Efaproxiral?

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.

What phase is Efaproxiral in?

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.

What clinical trials is Efaproxiral in?

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.

Is Efaproxiral the same as RSR13?

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.