check_circleStudy Completed

Prostatic Neoplasms

Bayer Identifier:

16506

ClinicalTrials.gov Identifier:

NCT01934790

EudraCT Number:

2013-003046-17

EU CT Number:

Not Available
Re-treatment safety of radium-223 dichloride in castration-resistant prostate cancer with bone metastases

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - Histologically or cytologically confirmed adenocarcinoma of the prostate at any given point in time during disease history
    - CRPC (castration-resistant prostate cancer) with clinical or radiologically confirmed bone progression
    - Treatment with 6 injections of radium-223 dichloride 50 kBq/kg and no evidence of progression to bone (according to Prostate Cancer Clinical Trials Working Group 2 [PCWG2] criteria) during the first course of treatment
    - Signed written informed consent prior to participating in any study related procedures. Willing and able to comply with the protocol, including follow-up visits and examinations
  • - History of a radium-223 dichloride-related serious adverse event (SAE) or CTCAE Grade 3 or 4 adverse event (AE) during or after the initial course of radium-223 dichloride treatment that led to the discontinuation of treatment
    - Less than 30 days from the last dose administered in the initial course of radium-223 dichloride treatment
    - Visceral metastases 1 cm or greater in largest diameter and / or requiring local or systemic therapeutic intervention, as assessed by abdominal and pelvic magnetic resonance imaging (MRI) / computed tomography (CT) scan and / or chest X-ray within 30 days of the start of treatment
    - Lymphadenopathy with lymph nodes exceeding 6 cm in short-axis diameter and / or requiring local or systemic therapeutic intervention. Enlarged lymph nodes of any size if the lymphadenopathy is thought to be a contributor to concurrent hydronephrosis.
    - Current central nervous system (CNS) metastases
    - Chronic conditions associated with non-malignant abnormal bone growth (e.g., confirmed Paget’s disease of bone)
    - Treatment with chemotherapy after the initial course of radium-223 dichloride treatment
    - Prior hemibody external radiotherapy
    - Prior systemic radiotherapy with strontium-89, samarium-153, rhenium-186, or rhenium-188
    - Any other serious illness or medical conditions
     -- Crohn’s disease or ulcerative colitis
     -- History of documented bone marrow dysplasia
     -- Unmanageable fecal incontinence
    - Imminent or established spinal cord compression based on clinical findings and / or MRI that has not yet been treated
    - Other malignancy treated within the last 3 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)

Trial summary

Enrollment Goal
45
Trial Dates
December 2013 - April 2017
Phase
Phase 1/Phase 2
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Galway, Ireland
Withdrawn
Cork, Ireland
Completed
Jerusalem, 9112001, Israel
Completed
Kfar Saba, 4428164, Israel
Completed
Haifa, 3109601, Israel
Completed
New Orleans, 70112, United States
Withdrawn
Stockholm, 171 76, Sweden
Withdrawn
Ålesund, 6026, Norway
Completed
Bergen, 5021, Norway
Completed
Lørenskog, 1478, Norway
Completed
Umeå, 901 85, Sweden
Completed
Kuopio, 70210, Finland
Withdrawn
Seinäjoki, FIN 60220, Finland
Withdrawn
Tampere, 33521, Finland
Completed
Málaga, 29010, Spain
Completed
Córdoba, 14004, Spain
Completed
Barcelona, 08025, Spain
Completed
Milano, 20133, Italy
Completed
Forlì-Cesena, 47014, Italy
Withdrawn
Genova, 16128, Italy
Withdrawn
Los Angeles, 90033, United States
Withdrawn
Los Angeles, 90033, United States
Withdrawn
Rostock, 18107, Germany
Withdrawn
München, 81675, Germany
Withdrawn
Dresden, 01307, Germany
Withdrawn
Nottingham, NG5 1PB, United Kingdom
Withdrawn
Belfast, BT9 7AB, United Kingdom
Completed
Petah Tikva, 4941492, Israel
Completed
Omaha, 68130, United States
Withdrawn
Stanford, 94305, United States
Completed
Syracuse, 13210, United States
Withdrawn
Charlotte, 28203, United States
Withdrawn
Aachen, 52074, Germany

Primary Outcome

  • Number of participants with treatment-emergent adverse events (AEs)
    An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom, or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. A treatment-emergent adverse events (TEAE) is defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of radium-223 dichloride.
    date_rangeTime Frame:
    Up to 2.5 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with treatment-emergent serious adverse events (SAEs)
    TESAE occurred after the start of radium-223 dichloride treatment until 30 days after the last dose and results in death; is life-threatening; requires inpatient hospitalization or prolongs existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly / birth defect; is another medically important serious event as judged by the investigator; or is an occurrence of leukemia, myelodysplastic syndrome, aplastic anemia, myelofibrosis, and primary bone cancer or any other new primary malignancy, such as acute myeloid leukemia.
    date_rangeTime Frame:
    Up to 2.5 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with Radium-223 dichloride-related AEs in the active follow-up period
    An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom, or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study.
    date_rangeTime Frame:
    Up to 2 years after last treatment
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with Radium-223 dichloride-related SAEs in the active follow-up period
    Treatment-related SAE is any SAE that, according to the investigator’s causality assessment, is possibly or probably related to treatment with radium-223 dichloride.
    date_rangeTime Frame:
    Up to 2 years after last treatment
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with high/low abnormalities in hematology variables at any visit after treatment start
    date_rangeTime Frame:
    Up to 2.5 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with high/low abnormalities in biochemistry variables at any visit after treatment start
    date_rangeTime Frame:
    Up to 2.5 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants who discontinued Radium-223 dichloride treatment due to treatment emergent AEs or death
    An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom, or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. A treatment-emergent adverse events (TEAE) is defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of radium-223 dichloride.
    date_rangeTime Frame:
    Up to 2.5 years
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A re-treatment safety study of radium-223 dichloride in subjects with castration-resistant prostate cancer with bone metastases who received an initial course of six doses of radium-223 dichloride 50 kBq/kg every four weeks
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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