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Radium-223 chloride

Phase 2

Breast Cancer | Small molecule | Oncology |Bayer AG|Last Updated: Jun 25, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment23

FDA Designations

No designations recorded

Clinical trial landscape

Radium-223 chloride · 2 trials · 5 indications

Phase 2 1Phase 1 1
NCT01070485BAY88-8223, Alpharadin, Breast Cancer Patients With Bone Dominant DiseaseBreast Cancer
COMPLETED23 Analytics
PHASE2COMPLETED
BAY88-8223, Alpharadin, Breast Cancer Patients With Bone Dominant Disease
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Changes in bone markers (urine levels of NTX (uNTX) and bone-alkaline phosphatase (ALP)
16 weeks
All safety data, including adverse events, occurrence of treatment-emergent adverse events, changes in laboratory variables, vital signs, ECG, physical examination, long term radiation toxicity, including results of bone marrow biopsy
1 year
Biodistribution, dosimetry and pharmacokinetics (whole body activity assessment, the counts in region-of-interest (ROIs) from anterior and posterior whole-body images, and the assay of activity in blood
6 days after injection

Secondary Endpoints

All safety data, including adverse events, changes in laboratory variables, vitals signs, physical examination, late toxicity
1 year
Biochemical markers (additional bone markers and CA15.3)
16 weeks
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
1 year
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Radium-223 dichloride (Xofigo, BAY 88-8223)EXPERIMENTALPatients were to receive 4 intravenous administrations of Radium-223 at a dose of 50 kBq/kg body weight (b.w) at intervals of 4 weeks. Radium-223 was given as add-on therapy to existing bisphosphonate therapy.
Radium-223 chloride (Xofigo, BAY88-8223)EXPERIMENTALThe patients will receive Radium-223 chloride as an escalating dose of either 50, 100 or 200 kBq/kg b.w. (0.0014, 0.0027 or 0.0054 mCi/kg).

Interventions

NameTypeDescription
Radium-223 chloride (BAY88-8223)DRUGThe required volume of study drug to be administered to a patient was calculated using the patient's body weight (50 kBq/kg b.w.).
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Eligibility Criteria

Age Range21 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Patient is female, and either post-menopausal (cessation of menses for more than 1 year) or surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy) or in therapy-induced premature menopause with LHRH agonists. If of childbearing potentia...

Countries:BelgiumNorwayUnited KingdomUnited States
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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 Radium-223 chloride

What is Radium-223 chloride used for?

Radium-223 chloride is an investigational oncology drug being studied for use in breast cancer and prostate cancer. It is being developed by Bayer AG. Clinical trials have focused on patients with bone metastases from these cancers, including a Phase 2 study in breast cancer patients with bone dominant disease.

What does Radium-223 chloride target?

Radium-223 chloride is a small molecule that acts as a radiopharmaceutical, targeting bone metastases. It delivers alpha radiation to areas of increased bone turnover, which are common sites of metastasis in prostate and breast cancer. This mechanism is designed to damage tumor cells in the bone while limiting exposure to surrounding healthy tissue.

Who makes Radium-223 chloride?

Radium-223 chloride is being developed by Bayer AG, a German pharmaceutical company traded on the OTC market under the ticker BAYRY. Bayer has conducted clinical trials of this compound in both prostate cancer and breast cancer patients with bone metastases.

What phase is Radium-223 chloride in?

Radium-223 chloride is in Phase 2 clinical development for breast cancer. It has completed a Phase 1 trial in prostate cancer and a Phase 2 trial in breast cancer. The drug is investigational and has not been approved by regulatory authorities for any indication.

What clinical trials is Radium-223 chloride in?

Radium-223 chloride has been studied in two completed clinical trials. NCT00748046 was a Phase 1 study in prostate cancer patients with skeletal metastases, enrolling 10 participants in the United States. NCT01070485 was a Phase 2 study in breast cancer patients with bone dominant disease, enrolling 23 participants in Belgium, Norway, and the United Kingdom.

Is Radium-223 chloride the same as Alpharadin?

Yes, Radium-223 chloride is also known as Alpharadin. Clinical trial records refer to the compound as both Radium-223 chloride and Alpharadin, with one trial titled "Alpharadin™ (Radium-223 Chloride) Safety and Dosimetry With HRPC That Has Metastasized to the Skeleton."