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Radium Ra 223 dichloride

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

Radium Ra 223 dichloride is an investigational small molecule being studied for the treatment of neoplasms, which are abnormal growths of tissue that can be cancerous. It is being evaluated in oncology for its potential to target bone lesions associated with cancer. The drug is currently in Phase 1 clinical development.

Who makes Radium Ra 223 dichloride?

Radium Ra 223 dichloride is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded under the ticker symbol BAYRY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with cancer and bone lesions.

What phase is Radium Ra 223 dichloride in?

Radium Ra 223 dichloride is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness. The drug is being studied in patients with neoplasms and bone diseases.

What clinical trials is Radium Ra 223 dichloride in?

Radium Ra 223 dichloride has been studied in one clinical trial with the identifier NCT02442063. This was a Phase 1b study that combined Radium Ra 223 dichloride with paclitaxel in cancer subjects with bone lesions. The trial was completed and enrolled 15 participants across Finland, Israel, and the United Kingdom.

Is Radium Ra 223 dichloride the same as radium-223?

Radium Ra 223 dichloride is a form of radium-223, a radioactive isotope. The drug is designed to deliver radiation to bone lesions, which are areas of abnormal bone growth often associated with cancer. It is being investigated for its potential to treat neoplasms, particularly those affecting the bones.