Clinical trial NCT02312960: Radium-223 Dichloride Long-term Follow-up Program
Official title: A Phase 4 Long-term Follow-up Study to Define the Safety Profile of Radium-223 Dichloride
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neoplasm Metastasis / Bone and Bones
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-12-09
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Patients will be followed up in this study after prior treatment with BAY88-8223 / Radium-223 dichloride / Xofigo.

Detailed description: This long-term follow up study will enroll subjects who will be transferred from selected interventional, company sponsored trials with radium-223 dichloride (feeder trials).

The primary objectives are to define the long term safety profile of radium-223 dichloride (for up to 7 years after the last dose of radium-223 dichloride); to assess the incidence of leukemia, myelodysplastic syndrome, aplastic anemia, and primary bone cancer or any other new primary malignancy; to assess the incidence of bone fractures and bone associated events (e.g., osteoporosis); and, in subjects who receive cytotoxic chemotherapy, to assess the incidence of febrile neutropenia and hemorrhage during their chemotherapy treatment and for up to 6 months thereafter at a frequency based on local clinical practice.

Eligibility criteria: Inclusion Criteria:

* Subject was previously enrolled in a selected company sponsored feeder trial, and has received at least 1 dose of radium 223 dichloride or placebo in the feeder trial

Exclusion Criteria:

* Not applicable to this follow up study

Primary outcomes:
measure: Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs)
timeFrame: Up to 7 years
measure: Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs)
timeFrame: Up to 7 years
measure: Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events
timeFrame: Up to 7 years
measure: Number of Participants With Leukemia
timeFrame: Up to 7 years
measure: Number of Participants With Myelodysplastic Syndrome
timeFrame: Up to 7 years
measure: Number of Participants With Aplastic Anemia
timeFrame: Up to 7 years
measure: Number of Participants With Primary Bone Cancer
timeFrame: Up to 7 years
measure: Number of Participants With Any Other New Primary Malignancy
timeFrame: Up to 7 years
measure: Number of Participants With Bone Fractures
timeFrame: Up to 7 years
measure: Number of Participants With Bone-associated Events
timeFrame: Up to 7 years
measure: Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy
timeFrame: Up to 7 years
measure: Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy
timeFrame: Up to 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Anchorage
country: United States
state: Alaska
city: Tucson
country: United States
state: Arizona
city: Plantation
country: United States
state: Florida
city: Indianapolis
country: United States
state: Indiana
city: Ashland
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Syracuse
country: United States
state: New York
city: Pittsburgh
country: United States
state: Pennsylvania
city: Watertown
country: United States
state: South Dakota
city: Seattle
country: United States
state: Washington
city: Darlinghurst
country: Australia
state: New South Wales
city: Westmead
country: Australia
state: New South Wales
city: Fitzroy
country: Australia
state: Victoria
city: Heidelberg
country: Australia
state: Victoria
city: Kortrijk
country: Belgium
city: Leuven
country: Belgium
city: Porto Alegre
country: Brazil
state: Rio Grande Do Sul
city: Barretos/SP
country: Brazil
state: Sao Paulo
city: São Paulo
country: Brazil
state: Sao Paulo
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Praha 2
country: Czechia
city: Helsinki
country: Finland
city: Tampere
country: Finland
city: Bordeaux Cedex
country: France
city: Nantes
country: France
city: Nîmes
country: France
city: Saint-Cloud
country: France
city: Tours
country: France
city: Villejuif
country: France
city: Ulm
country: Germany
state: Baden-Württemberg
city: Erlangen
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Rostock
country: Germany
state: Mecklenburg-Vorpommern
city: Aachen
country: Germany
state: Nordrhein-Westfalen
city: Mainz
country: Germany
state: Rheinland-Pfalz
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Dresden
country: Germany
state: Sachsen
city: Jena
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Bremen
country: Germany
city: Chai Wan
country: Hong Kong
city: Afula
country: Israel
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Petach Tikva
country: Israel
city: Ramat Gan
country: Israel
city: Tel Aviv
country: Israel
city: Zrifin
country: Israel
city: Forlì Cesena
country: Italy
state: Emilia-Romagna
city: Modena
country: Italy
state: Emilia-Romagna
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Milano
country: Italy
state: Lombardia
city: Trento
country: Italy
state: Trentino-Alto Adige
city: Matsuyama
country: Japan
state: Ehime
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Kanazawa
country: Japan
state: Ishikawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Kurashiki
country: Japan
state: Okayama
city: Osakasayama
country: Japan
state: Osaka
city: Hidaka
country: Japan
state: Saitama
city: Kita-Adachigun
country: Japan
state: Saitama
city: Koto-ku
country: Japan
state: Tokyo
city: Fukuoka
country: Japan
city: Kumamoto
country: Japan
city: Miyazaki
country: Japan
city: Osaka
country: Japan
city: Seoul
country: Korea, Republic of
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
state: Seoul Teugbyeolsi
city: Daegu
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Bodø
country: Norway
city: Oslo
country: Norway
city: Bialystok
country: Poland
city: Gliwice
country: Poland
city: Warszawa
country: Poland
city: Obninsk
country: Russian Federation
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Badalona (Barcelona)
country: Spain
state: Barcelona
city: Palma De Mallorca
country: Spain
state: Illes Baleares
city: A Coruña
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Málaga
country: Spain
city: Pamplona
country: Spain
city: Sevilla
country: Spain
city: Sevilla
country: Spain
city: Umea
country: Sweden
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Truro
country: United Kingdom
state: Cornwall
city: Plymouth
country: United Kingdom
state: Devon
city: Sheffield
country: United Kingdom
state: South Yorkshire
city: Guildford
country: United Kingdom
state: Surrey
city: Sutton
country: United Kingdom
state: Surrey
city: Coventry
country: United Kingdom
state: Warwickshire
city: Bristol
country: United Kingdom
city: Cottingham
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: