Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
- Registration Number
- NCT03301857
- Lead Sponsor
- Amgen
- Brief Summary
Study 20140114 will continue to follow participants with GCTB who were treated in Study 20062004 and remained on the study at the completion of Study 20062004 for an additional 5 years on long-term safety follow up.
- Detailed Description
Study 20140114 will continue to follow participants with GCTB who were treated in Study 20062004 and remained on the study at the completion of Study 20062004 for an additional 5 years on long-term safety follow up. Collection of long-term safety information will include adverse events of interest and all treatment-emergent adverse events and serious adverse events
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
- Participant was previously enrolled in Study 20062004.
- Participant or participant's legally acceptable representative has provided informed consent/assent prior to initiation of any study-specific activities/procedures.
- Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
- Females of childbearing potential on denosumab and not willing to continue to use 1 highly effective method of contraception during treatment and for 5 months after the end of treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Denosumab Denosumab Participants who are still being treated with denosumab when 20062004 completes: 120 mg administered subcutaneously (SC) every 4 weeks (Q4W). For participants undergoing retreatment with denosumab: 120 mg administered SC on Days 1, 8, 15 and 28 then every 4 weeks subsequently.
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI) Up to approximately 5 years EOIs assessed in the study were signs and symptoms of osteonecrosis of the jaw (ONJ), malignancy (including malignancy in GCTB), atypical femoral fracture (AFF), hypocalcemia, hypercalcemia after treatment discontinuation, pregnancy and lactation (if occurring during treatment or within 5 months of the last dose of denosumab). Hypocalcemia includes events that occurred after 30 days following the last dose of IP and includes TEAEs only. Other EOIs encompass all events from signing the informed consent to the end of the study (approximately 5 years). ONJ and AFF events were adjudicated by independent reviewers.
- Secondary Outcome Measures
Name Time Method Number of Participants With Disease Progression or Recurrence of GCTB Up to approximately 5 years Disease progression or recurrence is defined as the best post-baseline response of progressive disease (PD) without any post-baseline complete response (CR) /partial response (PR) /stable disease (SD) or a post-baseline response of PD following a post-baseline CR/PR/SD. PD is defined as the response of progressive disease, locally recurrent disease or distant recurrence. CR is defined as no evidence of disease following surgical resection while on study 20062004. PR is defined as no new lesion or disease progression while enrolled in study 20062004. SD is defined as local disease progression/recurrence or distant metastatic disease while on study 20062004.
Number of Participants Receiving GCTB Interventions Up to approximately 5 years GCTB interventions include: surgery, chemotherapy, embolization, interferon, and radiotherapy.
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) Up to approximately 5 years An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. An AE is considered as treatment-emergent if the AE occurs during the time period from the first dose of IP in this study through last dose of IP plus 30 days. TEAEs related to IP include only TEAEs for which the Investigator indicated there was a reasonable possibility they may have been caused by IP. AEs were graded (grade 3 \[severe or medically significant but not immediately life-threatening\], 4 \[life-threatening\], and 5 \[death related to the AE\]) using the Common Terminology Criteria for Adverse Events (CTCAE).
Trial Locations
- Locations (14)
Sarcoma Oncology Research Center LLC
🇺🇸Santa Monica, California, United States
Mount Sinai Beth Israel Downtown
🇺🇸New York, New York, United States
University of Minnesota Medical Center Fairview
🇺🇸Minneapolis, Minnesota, United States
Centre Leon Berard
🇫🇷Lyon CEDEX 08, France
Abramson Cancer Center at Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Institut Gustave Roussy
🇫🇷Villejuif, France
Istituti Ortopedici Rizzoli
🇮🇹Bologna, Italy
Hospital Universitari Son Espases
🇪🇸Palma de Mallorca, Baleares, Spain
Royal Orthopaedic Hospital
🇬🇧Birmingham, United Kingdom
Skane Universitetssjukhus
🇸🇪Lund, Sweden
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie â€" Panstwowy Instytut Badawczy
🇵🇱Warszawa, Poland
Washington Cancer Institute at MedStar Washington Hospital
🇺🇸Washington, District of Columbia, United States
Instytut Matki i Dziecka
🇵🇱Warszawa, Poland