CLINICAL TRIALS PROFILE FOR RADIUM RA-223 DICHLORIDE

All Clinical Trials for Radium Ra-223 Dichloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00699751 ↗	A Phase III Study of Radium-223 Dichloride in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases	Completed	Bayer	Phase 3	2008-06-01	ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone refractory prostate cancer and skeletal metastases.
NCT01516762 ↗	Radium-223 Dichloride (BAY88-8223) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases	No longer available	Bayer		1969-12-31	This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC patients diagnosed with symptomatic bone metastasis and to collect additional short and long term safety data on the product.
NCT01618370 ↗	Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases	Completed	Bayer	Phase 3	2012-07-22	This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product.
NCT01810770 ↗	Radium-223 Dichloride Asian Population Study in the Treatment of CRPC Patients With Bone Metastasis	Completed	Bayer	Phase 3	2013-03-26	To evaluate the safety and efficacy (Overall survival [OS]) of multiple doses of Ra-223 dichloride in an Asian population of subjects with CRPC metastatic to the bone.
NCT01833520 ↗	Phase I Dose Escalation of Monthly Intravenous Ra-223 Dichloride in Osteosarcoma	Completed	Bayer	Phase 1/Phase 2	2013-10-16	The goal of this clinical research study is to find the highest tolerable dose of radium-223 dichloride that can be given to patients with osteosarcoma. Radium-223 chloride is designed to work like radiation therapy in cells that are actively making bone. It is designed to target new bone growth in and around bone cancer and may kill cancer cells.
NCT01833520 ↗	Phase I Dose Escalation of Monthly Intravenous Ra-223 Dichloride in Osteosarcoma	Completed	M.D. Anderson Cancer Center	Phase 1/Phase 2	2013-10-16	The goal of this clinical research study is to find the highest tolerable dose of radium-223 dichloride that can be given to patients with osteosarcoma. Radium-223 chloride is designed to work like radiation therapy in cells that are actively making bone. It is designed to target new bone growth in and around bone cancer and may kill cancer cells.
NCT01934790 ↗	Re-treatment Safety of Radium-223 Dichloride in Castration-resistant Prostate Cancer With Bone Metastases	Completed	Bayer	Phase 1/Phase 2	2013-12-22	Eligible subjects must have completed 6 doses of treatment of radium-223 dichloride and experienced no radium-223 dichloride-related SAEs (serious adverse events) or CTCAE (Common Terminology Criteria for Adverse Events) Grade 3 or 4 adverse event during or after the initial course of radium-223 dichloride that led to the discontinuation of treatment. 40 Subjects will be enrolled and will receive up to 6 doses of radium-223 dichloride 50 kBq/kg IV every 4 weeks. The subject will be evaluated for AEs (adverse events) and laboratory tests at each visit every 4 weeks, prior to receiving radium-223 dichloride. After the end of treatment visit the subjects will enter the active follow up period. Related AEs and SAEs and Lab tests will be evaluated at each visit every 4 weeks for the first 12 weeks, then every 12 weeks for up to 2 years after the last dose of radium-223 dichloride. After the 2 years of active follow-up, subjects will enter the long-term follow-up period and will be followed via telephone follow-up at 6-month intervals for late toxicities and survival up to 7 years after the last dose of radium-223 dichloride or until death. Joint safety reviews will regularly take place to oversee safety of the subjects conducted at regular intervals. An interim analysis of the safety data will be conducted during the study.

Clinical Trial Conditions for Radium Ra-223 Dichloride

Condition Name

Condition Name for Radium Ra-223 Dichloride
Intervention	Trials
Prostatic Neoplasms	7
Prostate Cancer	4
Bone Metastases	4
Castration-Resistant Prostate Carcinoma	3

Condition MeSH

Condition MeSH for Radium Ra-223 Dichloride
Intervention	Trials
Prostatic Neoplasms	25
Neoplasm Metastasis	8
Carcinoma	6
Bone Neoplasms	3

Clinical Trial Locations for Radium Ra-223 Dichloride

Trials by Country

Trials by Country for Radium Ra-223 Dichloride
Location	Trials
United States	251
Italy	75
United Kingdom	60
Germany	53
Spain	36

Trials by US State

Trials by US State for Radium Ra-223 Dichloride
Location	Trials
California	17
New York	14
Pennsylvania	13
Michigan	12
Missouri	11

Clinical Trial Progress for Radium Ra-223 Dichloride

Clinical Trial Phase

Clinical Trial Phase for Radium Ra-223 Dichloride
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	4
Phase 2	15

Clinical Trial Status

Clinical Trial Status for Radium Ra-223 Dichloride
Clinical Trial Phase	Trials
Completed	12
Recruiting	10
Active, not recruiting	4

Clinical Trial Sponsors for Radium Ra-223 Dichloride

Sponsor Name

Sponsor Name for Radium Ra-223 Dichloride
Sponsor	Trials
Bayer	19
National Cancer Institute (NCI)	5
Carolina Research Professionals, LLC	2

Sponsor Type

Sponsor Type for Radium Ra-223 Dichloride
Sponsor	Trials
Industry	26
Other	19
NIH	5