Recent Updates
Recently added Catalysts

Radium-223 chloride

Phase 2

Breast Cancer | Small molecule | Oncology |Bayer AG|Trials Updated: Dec 14, 2015

Radium-223 chloride target and mechanism

ModalitySmall molecule

Also known as Radium-223 chloride (BAY88-8223)

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials3
Total Enrollment39

FDA Designations

No designations recorded

Radium-223 chloride clinical trials

Radium-223 chloride · 3 trials · 6 indications

Phase 2 1Phase 1 2
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
Estimation of whole-body retention of radioactivity at each imaging time post-injection
1 week
Estimation of the individual organ uptake/retention of radioactivity at each time-point post injection
1 week
Estimate retention of administered radioactivity in blood
Up to 1 week
Estimation of elimination of radioactivity in urine and faeces
2 days
Calculation of estimated absorbed radiation dose to target organs
1 week
Pharmacokinetics
1 week

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
Unlock Study Endpoints

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).
Radium-223 chlorideEXPERIMENTALIV administrations of 100 kBq/kg b.w (=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization). Two administrations took place with an interval of 6 weeks

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.).
Radium-223 chloride (Xofigo®, BAY88-8223) injectionDRUGSterile, clear and colourless aqueous solution of radium-223 chloride free of endotoxins, for intravenous administration
Unlock Study Design Details

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
Unlock Eligibility Criteria

Competitive Landscape -Breast Cancer 609 trials

Frequently asked questions about Radium-223 chloride

What is Radium-223 chloride?

Radium-223 chloride is an investigational small molecule oncology therapy developed by Bayer AG (ticker BAYRY). It has been studied in breast cancer, prostate cancer, and prostatic neoplasms, including patients with bone metastases. It is also known as BAY88-8223 and Alpharadin.

What is Radium-223 chloride used for in prostate cancer?

Radium-223 chloride has been studied in prostate cancer, specifically in patients with hormone-refractory prostate cancer that has metastasized to the skeleton. Trials have evaluated its safety, dosimetry, and pharmacokinetics in this population. It is not approved for these uses based on the available data.

Who makes Radium-223 chloride?

Radium-223 chloride is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor of the clinical trials evaluating the drug in breast cancer and prostate cancer.

What phase is Radium-223 chloride in?

Radium-223 chloride is in Phase 2 development. A Phase 2 trial in breast cancer patients with bone-dominant disease has been completed, and two Phase 1 trials in prostate cancer have also been completed. It remains an investigational therapy.

What clinical trials is Radium-223 chloride in?

Radium-223 chloride has been studied in three completed trials: NCT01070485, a Phase 2 trial in breast cancer with bone metastases; NCT00748046, a Phase 1 safety and dosimetry trial in hormone-refractory prostate cancer with skeletal metastases; and NCT00667537, a Phase 1 pharmacokinetic trial in prostatic neoplasms.

Is Radium-223 chloride the same as Xofigo or BAY88-8223?

Yes, Radium-223 chloride is also known as BAY88-8223 and Alpharadin. The name Xofigo is associated with radium-223 chloride as well. These alternative names refer to the same investigational compound developed by Bayer AG.