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Hormones

Radium Ra 223 dichloride

One injection to be administered every 4 weeks up to 6 injections. The dose per injection is 50 kBq/kg body weight.

Radium-223 dichloride (BAY88-8223)

Bayer Study Director

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.

Radium-223 Dichloride (BAY88-8223) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

Radium-223 Chloride (BAY88-8223) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

Bayer

Adenocarcinoma

Participants treated with standard dosing of Alpharadin 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).

50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).

Alpharadin

John Araujo, MD,PHD

The goal of this clinical research study is to learn more about how the study drug alpharadin (Radium-223) works in patients who have CPRC that has spread to the bone.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive radium-223 by vein over about 1 minute at the beginning of every study cycle for 6 cycles. Every 4 weeks is a study cycle.

You will need to be well hydrated before each dose by drinking at least 2-3 cups (8 ounces each) of water.

Do not take additional drugs, including over-the-counter products and herbal/alternative drugs, during the study without talking with the study doctor first.

Study Visits:

You will have a study visit before each dose of radium-223. The following tests and procedures will be performed:

* You will have a physical exam.
* Blood (about 3-4 tablespoons) will be drawn for routine and biomarker tests, as well as to check your PSA and testosterone levels.
* Urine will be collected for biomarker testing.

At Week 12, you will have bone marrow biopsy and aspiration performed to check the status of the disease and for biomarker testing.

At Week 24 the following tests and procedures will be performed:

* You will have a physical exam.
* Blood (about 3-4 tablespoons) will be drawn for routine tests, as well as to check your PSA and testosterone levels.

Length of Study:

You may receive the study drug for up to 6 doses. You will be taken off study early if the disease gets worse, if you have intolerable side effects, if your study doctor thinks it is in your best interest to stop, or if you are unable to follow study directions.

End of Treatment Visit:

After you stop receiving the study drug for any reason, the following tests and procedures will be performed:

* You will have a physical exam.
* You will have a sodium fluoride PET/CT scan to check the status of the disease.
* Blood (about 3-4 tablespoons) will be drawn for routine and biomarker tests, as well as to check your PSA and testosterone levels.
* Urine will be collected for biomarker testing.
* You will have a bone marrow aspiration and biopsy performed for biomarker testing.

Long-Term Follow-Up:

The study staff will check up on you about every 6 months after your last dose of study drug. This will consist of a phone call, an e-mail, or a review of your medical records. If you are contacted by phone, the call will last about 5 minutes.

This is an investigational study. Radium-223 is FDA approved and commercially available for the treatment of metastatic CRPC that has spread to the bones but not to other organs. It is investigational to look for biomarkers that may be related to CRPC in patients who are receiving radium-223.

The study doctor can explain how the study drug is designed to work.

Up to 25 participants will be enrolled in this study. All will take part at MD Anderson.

Radium 223 in Castrate Resistant Prostate Cancer Bone Metastases

An Observation, Open Label Study of Alpharadin (Radium 223) in Patients With Castrate Resistant Prostate Cancer Bone Metastases

Overall survival is measured in months from the time of enrollment until death. Participants who survived longer then the median survival rate of 24.3 months were assigned favorable survival. Participants who survived less than 24.3 months were assigned unfavorable survival.

Prostate Cancer Foundation

M.D. Anderson Cancer Center

Participants treated with standard dosing of Alpharadin 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).

Alpharadin: 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

PSA is produce by normal and cancerous prostate tissue. PSA levels are often elevated in men with prostate cancer.

Prostate Specific Antigen (PSA) Levels

Elevated total alkaline phosphatase is an indication that the prostate cancer has spread to bones. Normal range 38 126 U/L

Total Alkaline Phosphatase Level

Grade 0

Grade 1

ECOG measure a participant's daily living abilities. All participants in this trial are grade 0 and grade 1 Grade 0: Fully active Grade 1: light house work and office work. Restricted in physically strenuous activity

Eastern Cooperative Oncology Group (ECOG) Performance Status

Score of 7

Score of 8

Score of 9

Score of 10

Unknown

Gleason score grades prostate cancer based on the severity of the cancer The scores range from 2 -10. The higher the score the more severe the cancer. Gleason Score of 6 is the lowest cancer grade. Gleason score of 7 is an intermediate grade Gleason score of 8 -10 is a high grade

Gleason Score

Less than 20

More than 20

Participants are put into two categories.Those with less that 20 bone metastases. Those with more than 20 bone metastases.

Extent of Bone Metastases

John C. Araujo, Associate Professor, Genitourinary Medical Oncology

Unfavorable Survival

Favorable Survival

Overall Survival (Favorable and Unfavorable )

Overall Study

The study had 2 parts. Part 1a was designed with single injections of Radium-223 given to cohorts of 5 patients for each of 5 pre-defined dose levels. Part 1b was designed to retreat and fractionate the dose of Radium-223 in multiple injections.Based on the revised correction factor by calibration, recalculations verified that the single injection doses administered in the part 1a were : 46, 93, 163, 213 and 250 kBq/kg b.w. Two re-treated patients (dose group 6) received a second dose that resulted in a total dose of 250 kBq/kg b.w. The fractionated doses were 1/5 and ½ of the highest dose in part1b (i.e. 250kBq so 5 x 50 and 2 x 125 kBq/kg b.w. respectively).

- Single injection. Starting dose 46 kBq/kg b.w. Escalating doses 93, 163, 213 and 250 kBq/kg b.w. (9.8.2 Changes in addition to those described in amendments) After completion of the five dose levels above, the protocol was amended and the study extended to include patients to received multiple injections of Radium-223 - Re-treatment: Patients who had earlier been included in the study and received dose levels 46, 93 or 163 kBq/kg b.w. could be given a second injection, provided that the total dose did not exceed 250 kBq/kg b.w. - Fractionated dose (multiple dosing) Patients were given multiple injections in treatment: 5 injections of 50 kBq/kg b.w. at 3 weeks intervals. Patients were given multiple injections in treatment: 2 injections of 125 kBq/kg b.w. at 6 weeks interval

A new bone-seeking radiopharmaceutical drug, called Radium-223 dichloride (formerly known as "Alpharadin"), is currently under development. It is an injectable aqueous solution containing radium-223, a radionuclide that emits radiation of another quality and with a different distribution than radiopharmaceuticals currently in use.

After injection of the drug into the blood, a large portion of the drug will accumulate in the bones, and irradiate the skeletal metastases. The drug is expected to be retained longer in the painful sites of bone than in other sites of the body, and may alleviate pain through its radiation. Radium-223 is expected to be both efficacious as regards the targeted localised irradiation, and also to have a favourable safety profile.

The radiopharmaceutical drug Radium-223 has not been given to humans before. In this first clinical study in man, a so-called phase I study, the safety, tolerance and the toxicity of various radioactivity doses of Radium-223 will be evaluated.

Dose Escalation Study of Radium-223 Dichloride in Patients With Advanced Skeletal Metastases

A Phase I Open-label, Multicenter, Dose-escalating Study of Radium-223 in Patients With Advanced Skeletal Metastases

Skin and Connective Tissue Diseases

Rare Diseases

Recurrence

Sarcoma

Osteosarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Phase I Starting Dose of Ra-223 Dichloride: 50 kBq/kg by vein over several minutes on Day 1 of each 4-week cycle.

Phase II Starting Dose of Ra-223 Dichloride: MTD from Phase I.

Up to 3 groups of 3 participants will be enrolled in the Phase I portion of the study, and up to 6 participants will be enrolled in Phase II.

Phase I Starting Dose of Ra-223 Dichloride: 50 kBq/kg by vein over several minutes on Day 1 of each 4-week cycle.

Phase II Starting Dose of Ra-223 Dichloride: MTD from Phase I.

Ra-223 Dichloride

Vivek Subbiah, MD

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.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 3 groups of 3 participants will be enrolled in the Phase I portion of the study, and up to 6 participants will be enrolled in Phase II.

If you are found to be eligible to take part in this study, you will be assigned to a dose level of radium-223 dichloride based on when you join this study. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of radium-223 dichloride is found.

If you are enrolled in the Phase II portion, you will receive radium-223 dichloride at the highest dose that was tolerated in the Phase I portion.

Study Drug Administration:

You will receive radium-223 chloride by vein over several minutes on Day 1 of each 4-week cycle.

You should drink plenty of fluids before each study drug dose.

You and your caregivers will receive spoken and written instructions about safety precautions after receiving this drug.

Study Visits:

At all study visits, you will be asked about any drugs you may be taking and if you have had any side effects from them.

On Day 1 of Cycle 2-6:

* You will have a physical exam, including measurement of your vital signs
* You will complete a brief questionnaire about any pain that you may be experiencing. This questionnaire should take about 5-10 minutes to complete.
* Your performance status will be recorded.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* If you can become pregnant, you will have a urine or blood pregnancy test. If the doctor thinks it is needed, you will also have an ultrasound to check for pregnancy. To take part in this study, you cannot be pregnant.

Within 1-3 weeks after Cycle 3:

* You will have scans such as a bone scan and CT or MRI scan to check the status of the disease.
* Blood (about 1 tablespoon) will be drawn for routine tests.

You may have other routine tests done, including a pregnancy test, if the study doctor thinks it is needed.

Length of Study Drug Dosing:

You may continue taking the study drug for up to 6 cycles. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation in this study will be over once you have completed the end-of-dosing visit (and follow-up visits if applicable).

End-of-Dosing Visit:

About 30 days after your last study drug dose:

* You will be asked about any drugs you may be taking and if you have had any side effects from them.
* You will have a physical exam, including measurement of your vital signs.
* You will complete a brief questionnaire about any pain that you may be experiencing. This questionnaire should take about 5-10 minutes to complete.
* Your performance status will be recorded.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* You will have scans such as a bone scan and CT or MRI scan to check the status of the disease.

Follow-Up Visits:

If you are younger than 18 years old, your height and weight will be measured 1 time a year until you turn 21. These measurements may stop earlier if your height stays about the same for 2 years in a row.

Information about your health status and any side effects (especially related to your bones) will be collected and reported to the study staff every year.

This is an investigational study. Radium-223 dichloride is commercially available and FDA approved for the treatment of certain types of prostate cancer. It is currently being used for research purposes only.

Up to 20 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Phase I Dose Escalation of Monthly Intravenous Ra-223 Dichloride in Osteosarcoma

The goal of this initial study is to determine the safety of escalating doses of monthly Ra-223 dichloride in the number of osteosarcoma participants with osteoblastic bone-forming metastases until MTD or a dose 100 kBq/kg dose is reached (whichever is first).

Alkaline phosphatase reduction to quantitative imaging techniques (99mTc-MDP, 18FDG-PET-CT, 18FNa PET-CT scans) to determine objective response of osteosarcoma indicator lesions to 223-radium dichloride. \>30% increase in SUV peak indicates progression, if \>30% decrease in SUV peak indicates a response and other does not meet above criteria or mixed response using the NAFCIST and PERCIST criteria.

Radium-223 dichloride will be given monthly for up to 6 cycles and side effects of this bone-targeted therapy on monthly blood counts and alkaline phosphatase will be determined.

Ra-223 dichloride will be administered as a slow bolus IV injection at intervals of every 4 weeks for up to 6 cycles.

Escalation 50 kBq/kg

Escalation 75 kBq/kg

Escalation 100 kBq/kg

Expansion 100 kBq/kg

Dose level: 50 kBq/kg, 75 kBq/kg and 100 kBq/kg. Radium-223 dichloride will be given monthly for up to 6 cycles and side effects of this bone-targeted therapy on monthly blood counts and alkaline phosphatase will be determined.

Ra-223 dichloride will be administered as a slow bolus IV injection at intervals of every 4 weeks for up to 6 cycles.

Escalation

Dose level: 100 kBq/kg. Radium-223 dichloride will be given monthly for up to 6 cycles and side effects of this bone-targeted therapy on monthly blood counts and alkaline phosphatase will be determined.

Ra-223 dichloride will be administered as a slow bolus IV injection at intervals of every 4 weeks for up to 6 cycles.

Expansion

Total

Age, Categorical

Vivek Subbiah,Associate Professor, Invest. Cancer Therapeutics

Maximum Tolerated Dose (MTD) of Ra-223 Dichloride in Osteosarcoma

>30% increase in SUV peak

>30% decrease in SUV peak

Other/Mixed Response

Number of Participants With Objective Response of Osteosarcoma Indicator Lesions to 223-Radium Dichloride

Breast Neoplasms

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Tamoxifen

Fulvestrant

Denosumab

Aromatase Inhibitors

Hormone Antagonists

Ra-223 dichloride 55 kBq/kg administered as a bolus intravenous (IV) injection (over 1 minute) through a secure in-dwelling catheter on day 1 of the study and then every four weeks thereafter for 6 cycles.

Denosumab 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.

A single hormonal agent (ie, Tamoxifen or Aromatase Inhibitor or Fulvestrant) administered daily while on study. Physician to decide what type of hormone therapy participant will receive.

55 kBq/kg by vein on Day 1 of each 28 day cycle, and then every four weeks thereafter for 6 cycles.

Ra-223 dichloride

120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.

A single hormonal agent administered daily while on study. Physician to decide what type of hormone therapy participant will receive.

Hormone Therapy

Naoto Ueno, MD, PHD

The goal of this clinical research study is to learn if Xofigo® (also called Ra-223 dichloride) combined with hormone therapy and denosumab can help to control breast cancer that has spread to the bones and/or bone marrow. The safety of this study drug combination will also be studied.

This is an investigational study. Denosumab and the hormone therapies used in this study are FDA-approved and commercially available for the treatment of metastatic breast cancer. Ra-223 dichloride is FDA-approved and commercially available for the treatment of bone metastases. It is considered investigational to use the combination of Ra-223 dichloride, hormone therapy and denosumab to treat patients with bone cancer that has spread to the bones.

The study doctor can explain how the study drugs are designed to work.

Up to 36 participants will be enrolled in this study. All will take part at MD Anderson.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive Ra-223 dichloride by vein over no more than 1 minute on Day 1 of each 28-day study cycle.

You will also receive denosumab as an injection under the skin on Day 1 of Cycles 1- 6.

You will also receive hormone therapy while on study. Your doctor will discuss with you what type of hormone therapy you will have, how it will be given, and its risks.

Study Visits:

On Day 1 of Cycle 1, blood (about 2 teaspoons) will be drawn for routine tests.

On Day 1 of Cycles 2-5:

* You will have a physical exam.
* Blood (about 2 teaspoons) will be drawn for routine tests.

On Day 1 of Cycle 6:

* Blood (about 2 teaspoons) and urine will be collected for routine tests.
* Blood (about 3 tablespoons) will be drawn for biomarker testing, including genetic biomarkers.
* Blood (about 5 teaspoons) will be drawn to test for CTCs, tumor markers, and genetic testing.
* You will have a PET-CT scan and a bone scan to check the status of the disease. If the doctor thinks it is needed, you will also have an MRI.

Length of Study Participation:

You may continue taking the study drugs for up to 6 cycles. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation will be over after the end-of-study visit.

End-of-Study Visit:

After your last dose of study drug:

* You will have a physical exam.
* Blood (about 2 teaspoons) and urine will be collected for routine tests.
* Blood (about 3 tablespoons) will be drawn for biomarker testing, including genetic biomarkers.
* Blood (about 5 teaspoons) will be drawn to test for CTCs, tumor markers, and genetic testing.
* You will have a PET-CT scan and either a bone scan or a CT scan to check the status of the disease. If the doctor thinks it is needed, you will also have an MRI.
* If the doctor thinks it is needed, you will have a bone marrow aspiration/biopsy to check the status of the disease.

Trial of Ra-223 Dichloride in Combination With Hormonal Therapy and Denosumab in the Treatment of Patients With Hormone-Positive Bone-Dominant Metastatic Breast Cancer

Phase II Trial of Ra-223 Dichloride in Combination With Hormonal Therapy and Denosumab in the Treatment of Patients With Hormone-Positive Bone-Dominant Metastatic Breast Cancer

Disease control rate is defined as the rate of the patients at that time with clinically complete or partial response or stable disease.

Ra-223 dichloride 55 kBq/kg administered as a bolus intravenous (IV) injection (over 1 minute) through a secure in-dwelling catheter on day 1 of the study and then every four weeks thereafter for 6 cycles.

Denosumab 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.

A single hormonal agent (ie, Tamoxifen or Aromatase Inhibitor or Fulvestrant) administered daily while on study. Physician to decide what type of hormone therapy participant will receive.

Ra-223 dichloride: 55 kBq/kg by vein on Day 1 of each 28 day cycle, and then every four weeks thereafter for 6 cycles.

Denosumab: 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.

Hormone Therapy: A single hormonal agent administered daily while on study. Physician to decide what type of hormone therapy participant will receive.

Ra-223 Dichloride + Denosumab

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Dr. Naoto T Ueno, Professor, Breast Medical Oncology

1 patient was lost to FU between 6 and 9 months from first dose of Radium -223

Number of Participants With Disease Control Rate at 9 Months

The Number of Participants With Disease Control Rate at 6 Months

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.

Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

Safety variables to be analyzed during the treatment period include: ECOG PS, Skeletal-related events, Treatment emergent Grade 3-4 AEs, any grade of treatment-related AEs and SAEs, Safety laboratory tests including hematology and serum chemistry

Safety variables to be analyzed during the follow-up period include: Skeletal-related events, Treatment related AEs and SAEs, Secondary malignancies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radium-223 Dichloride (BAY88-8223) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases	NCT01516762	Prostatic Neopl...	Radium-223 dich...	18 Years -	Bayer
Radium-223 Dichloride (BAY88-8223) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases	NCT01516762	Prostatic Neopl...	Radium-223 dich...	18 Years -	Bayer
Radium 223 in Castrate Resistant Prostate Cancer Bone Metastases	NCT02135484	Prostate Cancer	Alpharadin	18 Years -	M.D. Anderson Cancer Center
Dose Escalation Study of Radium-223 Dichloride in Patients With Advanced Skeletal Metastases	NCT01798108	Neoplasm Metast...	Radium-223 dich...	30 Years -	Bayer
Phase I Dose Escalation of Monthly Intravenous Ra-223 Dichloride in Osteosarcoma	NCT01833520	Sarcoma	Ra-223 Dichlori...	15 Years -	M.D. Anderson Cancer Center
Trial of Ra-223 Dichloride in Combination With Hormonal Therapy and Denosumab in the Treatment of Patients With Hormone-Positive Bone-Dominant Metastatic Breast Cancer	NCT02366130	Breast Cancer	Ra-223 dichlori... Denosumab Hormone Therapy	18 Years -	M.D. Anderson Cancer Center
Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases	NCT01618370	Prostatic Neopl...	Radium-223 dich...	18 Years -	Bayer
Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases	NCT01618370	Prostatic Neopl...	Radium-223 dich...	18 Years -	Bayer

Spots Global Cancer Trial Database for alpharadin

Every month we try and update this database with for alpharadin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for alpharadin

Every month we try and update this database with for alpharadin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for alpharadin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.