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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

Docetaxel

Tubulin Modulators

Antimitotic Agents

There are four dose cohorts (1, 1a, 2, 2a) in this arm and two dose levels of docetaxel (40mg/m\^2 \[level 1\] and 50mg/m\^2 \[level 2\]). Dosing of Radium 223 remains the same in all cohorts (55 KBq/kg given every 28 days for 6 cycles).

Maximum tolerated dose (MTD) of docetaxel will be assessed. MTD is defined as the highest dose-level, among those tested, associated with a rate of less than a 33% dose limiting toxicity (DLT).

If the maximum tolerated dose (MTD) of docetaxel is found in arm 1, this dose level will be expanded to include an additional 25 subjects to confirm the safety and explore the preliminary anti-cancer effect. If the MTD is not identified, the study will be stopped and the expansion cohort will not be accrued.

Docetaxel will be administered every 2 weeks (on Day 1 and Day 15 of a 28 day cycle). Fractionated dosing dependent on cohort.

Radium 223 will be delivered every 28 days (on day 1) for 6 cycles.

Radium 223

Paul Mathew, MD

The objective of this study is to determine the maximum safe dose of Ra-223 in combination with fractionated (split doses) docetaxel when given to subjects and to determine the best administering dose. The study will look at side effects that may happen while taking the combination treatment. A total of approximately 18 subjects will take part in the dose escalation part of the study and an additional 25 subjects will participate in the expansion cohort. This study will be conducted across four centers in the United States.

The primary objective of this study is to assess the safety and toxicity of a fractionated docetaxel schedule in combination with standard Ra-223.

Secondary Objectives include: assessment of progression-free survival, time to treatment failure, overall survival, ability of subjects to complete 6 cycles of the combination therapy, assessment of Prostate Specific Antigen (PSA) kinetics and objective responses (measurable disease), assessment of quality of life and assessment of bone bio-marker outcomes.

The study features a 4-week lead-in period with docetaxel monotherapy to assess for docetaxel intolerance. The lead-in period is then followed by combination therapy with Ra-223 every 4 weeks for 6 cycles in a traditional Phase I dose-escalation design.

A provision has been made to include prophylactic granulocyte colony stimulating factor (G-CSF) cohorts after the lead-in period if neutropenia is the dose limiting toxicity at either dose level.

The investigators hypothesize that the fractionated dosing of docetaxel will significantly mitigate the hematologic toxicity, preserve antineoplastic activity and allow for maintenance of the 4-weekly Ra-223 schedule.

Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer

A Phase I Trial of Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer (CRPC)

DLT is defined as a subject in any cohort experiencing any of the following adverse events during cycle 1 of treatment, until cycle 2 day 1 of treatment: Thrombocytopenia (platelets \< 75 x 10\^9/L on C1D15 or \< 100 x 10\^9/L on C2D1), Neutropenia (ANC \< 1000 K/mL on C1D15 or ANC \< 1500 K/mL on C2D1), Grade 3 (by CTCAE v4) fatigue lasting ≥ 7 days, other non-hematologic toxicity ≥ grade 3, lasting ≥ 48 hours at least possibly related to treatment, or any toxicity (non-hematologic or hematologic) at least possibly related to treatment requiring dose reduction or dose interruption.

Time to progression of disease, calculated as a time-to-event endpoint

Progression free survival is defined as the interval from first dose date of study drug to the earlier of the first documentation of definitive disease progression (assessed per PCWG2) or death from any cause

A measurement from the date of randomization to the first event which meets the criteria for disease progression (assessed per PCWG2 criteria) or death from any cause

Overall survival is defined as the interval from first dose date of study drug to death from any cause.

The number of subjects who were able to receive both lead-in doses of docetaxel and all 6 cycles of combination docetaxel and Ra223 on time (+/- 7 days).

Measurable disease calculated at each time point in which the data is collected. We will use mixed effect models to explore the temporal trajectories for the outcome changes over time in response to the treatment.

Measured by the Brief Pain Inventory (BPI) and Functional Assessment of Cancer Therapy (FACT-G) Questionnaires

Measurement of bone-specific alkaline phosphatase and urine N-telopeptides (laboratory testing)

Lahey Clinic

Henry Ford Hospital

Ohio State University Comprehensive Cancer Center

Tufts Medical Center

Pharmaceutical Solutions

During dose level 1, tasquinimod will start at 0.25mg/day orally with a goal of 0.5mg/day. Dose level 2 will start at 0.25mg/day with a goal of 1mg/day.

Radium-223 will be administered per FDA-approved dosing (six IV injections at a dose of 50kBq/kg of body weight, administered every 4 weeks).

Tasquinimod is a quinoline-3-carboxamide analog that has demonstrated significant improvements in progression-free survival and overall survival in men with CRPC in a phase II trial.Tasquinimod will be administered at three dose levels (dose levels 1, 2, and -1). During dose level 1, tasquinimod will start at 0.25mg/day orally with a goal of 0.5mg/day. Dose level 2 will start at 0.25mg/day with a goal of 1mg/day. Dose level -1 will be 0.25mg/day without dose titration.

Tasquinimod

Radium Ra 223 dichloride, an alpha particle-emitting pharmaceutical, is a radiotherapeutic drug. Radium 223 is supplied as a clear, colorless, isotonic, and sterile solution to be administered intravenously with pH between 6 and 8. Each milliliter of solution contains 1,000 kBq radium-223 dichloride (27 microcurie), corresponding to 0.53 ng radium-223, at the reference date. Radium is present in the solution as a free divalent cation.Radium-223 will be administered per FDA-approved dosing (six IV injections at a dose of 50kBq/kg of body weight, administered every 4 weeks).

Mario Eisenberger, MD

This is a Phase I/Ib study of Radium-223 in combination with Tasquinimod for patients with bone metastases from castration-resistant prostate cancer (CRPC).

The investigators propose to determine the spectrum of tolerability of the combination of tasquinimod and radium-223 and determine a dose for a subsequent randomized phase II study (first cohort) and the proportion of men with bone-specific alkaline phosphatase response (second cohort).

This is a study of Radium-223 in combination with Tasquinimod. The target population is patients with bone metastases from castration-resistant prostate cancer intended for treatment with radium-223.

After baseline assessment, all subjects will receive six cycles of Radium-223 separated by an interval of 28 days. Radium-223 will be administered per FDA-approved dosing (six IV injections at a dose of 50kBq/kg of body weight, administered every 4 weeks). The treatment maintenance dose of tasquinimod will be a maximum of 1 mg of tasquinimod taken once daily with water (\~200 mL). The initial target dose of tasquinimod is 0.5mg/day. All subjects will be followed up for 12 months after start of study treatment.

The investigators propose a phase I/Ib trial of the addition of tasquinimod to FDA-approved doses of radium-223 in men with symptomatic bone-only metastatic CRPC. The investigators anticipate that given their distinct mechanisms of action and non-overlapping toxicity profiles that additive or synergistic toxicity would be minimal. The investigators hypothesize that adding tasquinimod to radium therapy may result in improved measures of efficacy including reduction in total alkaline phosphatase, time to first skeletal-related event and PSA and radiographic progression-free survival.

In the Phase I portion of dose-escalation scheme, the dose escalation will follow a 3+3 design with intra-patient dose-escalation from 0.25mg/day of tasquinimod to a goal dose of either 0.25mg (dose-level -1), 0.5mg (dose-level 1), or 1.0mg/day (dose-level 2) based on individual tolerability.

Upon identifying a recommended Phase II combination dose-level of Radium-223 and tasquinimod, the investigators will move to the Phase Ib portion and open an expanded cohort of up to 35 additional patients to achieve a total of 38 patients treated at the recommended phase II dose-level (including those from the dose-escalation phase).

A Study of Radium-223 in Combination With Tasquinimod in Bone-only Metastatic Castration-Resistant Prostate Cancer

A Phase I/Ib Study of Radium-223 in Combination With Tasquinimod in Bone-only Metastatic Castration-Resistant Prostate Cancer

Radium-223 micro-scale dosimetry in bone tissue using bone biopsy material before and after treatment at 3 time points.

Longitudinal whole-body planar gamma camera imaging will provide information on how tasquinimod impacts the overall skeletal distribution and uptake of Ra-223.

Longitudinal whole-body planar gamma camera imaging will provide information on how tasquinimod impacts on the organ-level dosimetry and uptake of Ra-223.

Safety of combining Radium-223 with tasquinimod will be assessed by the incidence and severity of toxicities (adverse events and serious adverse events).

Bone-specific alkaline phosphatase (serum bone markers) response will be described as percentage of change from baseline to 6 months or earlier for those who discontinue study therapy

Time to radiographic or clinical progression or death, whichever comes first (progression free survival; PFS). Based on RECIST version 1.1 and Prostate Cancer Working Group 2 (PCWG2) definitions including:

1. Progression of soft tissue lesions according to RECIST 1.1
2. Progression of bone lesions detected with bone scan according to PCWG2 criteria
3. Radiologically-confirmed spinal cord compression or pathological fracture due to malignant progression
4. Either of: time to first symptomatic SRE or symptomatic progression.

Time to first symptomatic SRE (defined as first use of XRT to relieve skeletal symptoms, new pathologic vertebral or nonvertebral bone fractures, spinal cord compression, or tumor -related orthopedic surgical intervention).

To determine proportion of patients without symptomatic progression at 6 months, defined as any one or more of:

1. Regular consumption of narcotic analgesics (single IV dose or \>10 of 14 days of oral narcotic use)
2. Requirement for radiation therapy for control of tumor-related pain
3. VAS pain rating of \>4 due to cancer pain on two consecutive ratings

The percentage of change in PSA from baseline to 12 weeks.

PSA progression (PSA progression free survival; PSA-PFS) will be defined per the PCWG2 guidelines

1. For those subjects showing an initial decline in PSA from baseline, is defined as an increase in PSA that is ≥25% and ≥2 ng/mL above the nadir, and which is confirmed by a second value 3 or more weeks later (i.e., a confirmed rising trend).
2. For those subjects with no decline in PSA from baseline, is defined as an increase in PSA that is ≥25% and ≥2 ng/mL after 12 weeks.

Time to death after start of study treatment (overall survival; OS)

Changes in other bone markers:

1. Serum C-telopeptide(uCTX-1)
2. N-terminal propeptide of procollagen type 1 (P1NP)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Gland and Hormone Related Diseases

Thyroid Diseases

Thyroid Neoplasms

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Micronutrients

Anti-Infective Agents

Iodine

Cadexomer iodine

Radium-223 (Xofigo®) will be supplied in vials as a ready-to-use solution for intravenous administration. The activity (administered radioactivity) will be 50 kBq/kg b.w., and multiple treatment activities up to 6 injections will be administered at intervals of 4 weeks.

Sophie LEBOULLEUX, MD

The purpose of this Phase II single-arm study is to evaluate the efficacy of Radium-223 in treating bone lesions from differentiated thyroid cancer that are I-131 refractory. Based on the results of the phase III trial, the protocol using an injection of Radium-223 activity of 50 kBq/kg b.w. given 6 times at 4 weeks interval will be applied. The end point of this study will be the evaluation of Radium-223 efficacy one month after 3 administrations, i.e. at 3 months after the first injection. If disease progression at that time is excluded, patients will be treated with 3 further injections for a total of 6 administrations of Radium-223. The principal response criterion at 3 and 6 months will be the metabolic response on FDG PET/CT, but other imaging techniques will also be performed: axial skeleton MRI, 99mTc-HMDP bone scan and FNa PET/CT. Axial skeleton MRI is the reference for soft tissue study. 99mTc- HMDP bone scan is the most used and available routine tool to detect bone metastases in cancer patients, but its sensitivity in patients with bone metastases from thyroid cancer is low, because most lesions are lytic \[23\]. 18FNa PET/CT shows higher sensitivity than 99mTc-HMDP bone scan to detect bone lesions in cancer patients and is able to detect micrometastases that are not seen on bone scan \[24\] \[25\]. Preliminary results show some interest of using this tracer to evaluate the sclerotic component of bone metastases from thyroid cancer \[26\]. Furthermore preliminary data show that FNa PET/CT can be useful to quantify response to Radium-223 in prostate cancer. In only five patients evaluated by FNa PET/CT at baseline, 6 weeks and 12 weeks after 100 KBq/Kg of Radium-223, semiquantitative analysis by SUV max showed a relationship between PSA and SUV max level decrease in 3 patients (-44%, -31%, -27% vs -52%, -75, and -49% respectively) \[27\].

Finally bone metastases that are visible on morphological imaging (CT scan or on RI) are frequently submitted to local treatment modalities, and this may induce fibrosis and recalcification. Therefore, already treated metastases and not treated metastases will be studied separately as two separate subgroups of target lesions.

Efficacy of Radium 223 in Radioactive Iodine Refractory Bone Metastases From Differentiated Thyroid Cancer

Single Arm Phase II Trial Evaluating the Efficacy of Radium 223 in Radioactive Iodine Refractory Bone Metastases From Differentiated Thyroid Cancer

Metabolic response according to PERCIST criteria in up to five lesions on FDG PET/CT performed 1 month after 3 monthly injections of Radium 223

evaluated on a 0-to-10 numerical rating scale completed by the patients

Partial pain response is defined as an improvement ≥30% and \<50% of the worst pain compared to score at baseline. Complete pain response is defined as an improvement ≥50% of the worst pain score compared to score at baseline

evaluated with the QLQ-C30 and QLQ-BM22 questionnaires

) confirmed by imaging defined as: (i) local progression with indication for local treatment such as surgery, thermoablation, cement injection, external beam radiation, or (ii) pathological fracture, spinal cord compression (iii) appearance of new bone lesions.

Gustave Roussy, Cancer Campus, Grand Paris

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
Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer	NCT03737370	Metastatic Cast...	Docetaxel Radium 223	18 Years -	Tufts Medical Center
A Study of Radium-223 in Combination With Tasquinimod in Bone-only Metastatic Castration-Resistant Prostate Cancer	NCT02396368	Prostate Cancer Bone-only Metas...	Tasquinimod Radium 223	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer	NCT03737370	Metastatic Cast...	Docetaxel Radium 223	18 Years -	Tufts Medical Center
Efficacy of Radium 223 in Radioactive Iodine Refractory Bone Metastases From Differentiated Thyroid Cancer	NCT02390934	Thyroid Cancer	Radium 223	18 Years -	Gustave Roussy, Cancer Campus, Grand Paris
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 radium 223

Every month we try and update this database with for radium 223 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 radium 223

Every month we try and update this database with for radium 223 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 radium 223 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.