At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 56 enrolled
Drug / intervention
Denosumab +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2 Study of Denosumab (NSC# 744010), a RANK Ligand Antibody, for Recurrent or Refractory Osteosarcoma
In Brief
A Phase 2 clinical trial evaluating Denosumab, Laboratory Biomarker Analysis, and 1 other intervention for Metastatic Osteosarcoma and 5 related conditions. Completed, enrolled 56 participants across 141 sites in 3 countries.
Detailed Summary
This phase II trial studies how well denosumab works in treating patients with osteosarcoma that has come back (recurrent) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as denosumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Osteosarcoma, Recurrent Osteosarcoma, Refractory Osteosarcoma, Stage IV Osteosarcoma AJCC v7, Stage IVA Osteosarcoma AJCC v7, Stage IVB Osteosarcoma AJCC v7
CountriesCanada, Puerto Rico, United States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartNov 2015
Primary CompletionDec 2019
Study CompletionDec 2023
TodayJul 2026
First PostedJun 12, 2015
Enrollment StartNov 21, 2015
Primary CompletionDec 31, 2019
Study CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 11.1 years ago
Interventions
Denosumabbiological
Given SC
Laboratory Biomarker Analysisother
Correlative studies
Pharmacological Studyother
Correlative studies