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Radium Ra 223 dichloride

Phase 1FDA approved

Neoplasms | Small molecule | Oncology |Bayer AG|Trials Updated: Nov 30, 2016

Radium Ra 223 dichloride development status

FDA approval on record May 15, 2013 as Xofigo
Approval holderBayer Hlthcare
ApplicationNDA203971
Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2017

Label indication Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. ( 1 ) FDA label

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Radium Ra 223 dichloride clinical trials

Radium Ra 223 dichloride · 1 trial · 2 indications

Phase 1 1
NCT02442063Phase Ib Study of Radium Ra 223 Dichloride in Combination With Paclitaxel in Cancer Subjects With Bone LesionsNeoplasms
COMPLETED15 Analytics
PHASE1COMPLETED
Phase Ib Study of Radium Ra 223 Dichloride in Combination With Paclitaxel in Cancer Subjects With Bone Lesions
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

The percentage of participants with thrombocytopenia during cycle 1 (paclitaxel alone), 2 and 3 (combination treatment)
Approximately 12 weeks
The percentage of participants with neutropenia during cycle 1 (paclitaxel alone), 2 and 3 (combination treatment)
Approximately 12 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
Radium Ra 223 dichlorideEXPERIMENTALRadium Ra 223 dichloride (Xofigo, BAY88-8223)

Interventions

NameTypeDescription
Radium Ra 223 dichloride (Xofigo, BAY88-8223)DRUG50 kBq/kg intravenous injection once every 4 weeks, will be administrated from cycle 2 up to 6 cycles
paclitaxelDRUG90 mg/m2 intravenous injection per week in a 3-week-on / 1-week-off regimen, will be administered as per local standard of care, starting in cycle 1
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Male or female patients ≥ 18 years of age * Subjects diagnosed with histologically or cytologically confirmed malignant solid tumors and at least two according bone lesions. A standard of practice bone scan for the documentation of at least 2 bone lesions can be used as long a...

Countries:FinlandIsraelUnited Kingdom
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Frequently asked questions about Radium Ra 223 dichloride

What is Radium Ra 223 dichloride?

Radium Ra 223 dichloride is an investigational small molecule oncology therapy developed by Bayer AG (ticker BAYRY). It has been studied in patients with neoplasms and bone lesions, specifically in a Phase 1 trial combining it with paclitaxel. It is also known by the names Xofigo and BAY88-8223.

What is Radium Ra 223 dichloride used for?

Radium Ra 223 dichloride has been studied for use in patients with neoplasms and bone lesions. The only clinical trial listed for this drug evaluated it in combination with paclitaxel in cancer subjects with bone lesions. It is not approved for any indication based on the available data.

Who makes Radium Ra 223 dichloride?

Radium Ra 223 dichloride is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor of the Phase 1 trial that studied this drug in combination with paclitaxel in cancer patients with bone lesions.

What phase is Radium Ra 223 dichloride in?

Radium Ra 223 dichloride is in Phase 1 clinical development. The only trial on record is a completed Phase 1 study. There are no active trials listed for this drug. It is investigational and has not been approved for any indication.

What clinical trials is Radium Ra 223 dichloride in?

Radium Ra 223 dichloride has been studied in one completed Phase 1 trial, NCT02442063, titled "Phase Ib Study of Radium Ra 223 Dichloride in Combination With Paclitaxel in Cancer Subjects With Bone Lesions." The trial enrolled 15 patients across Finland, Israel, and the United Kingdom.

Is Radium Ra 223 dichloride the same as Xofigo?

Yes, Radium Ra 223 dichloride is also known as Xofigo and by the code name BAY88-8223. These names refer to the same drug developed by Bayer AG. The alternative names are used interchangeably in prescribing and research contexts.