Trial · NCT02470091
Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma
NCT02470091, Phase 2, Completed, Children's Oncology Group; results first posted 2021-02-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma. Trials, record NCT02470091. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02470091
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma
- NCT number
- NCT02470091
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 56 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Metastatic Osteosarcoma, Recurrent Osteosarcoma, Refractory Osteosarcoma, Stage IV Osteosarcoma AJCC v7, Stage IVA Osteosarcoma AJCC v7, Stage IVB Osteosarcoma AJCC v7
- Interventions
- Denosumab, Laboratory Biomarker Analysis, Pharmacological Study
- First posted
- 2015-06-12
- Last updated
- 2024-01-22
- Results first posted
- 2021-02-21
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Control Rate (Cohort I) | At 4 months | Disease control interval was calculated as the time from enrolment until detection of new disease or progression of an existing site of disease as determined by the treating physician. Disease control interval of at least 4 months was considered disease control success. |
| Primary | Response Evaluation Criteria in Solid Tumors (RECIST) Response (Complete Response [CR] or Partial Response [PR] vs Not CR or PR) (Cohort I) | At 4 months | Per Response Evaluation Criteria In Solid TumorsCriteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response(CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Primary | Disease Control Rate (Cohort II) | At 12 months | Disease control interval was calculated as the time from enrolment until detection of new disease as determined by the treating physician. Disease control interval of at least 12 months was considered disease control success. |
| Secondary | Pharmacokinetic (PK) Parameters: Mean of Trough Concentrations of Denosumab | Days 1, 8, 15, and 22 of course 1, day 1 of courses 2-4 and 7, and days 1 and 15 of course 6 | Sample means of trough concentrations of denosumab will be calculated. |
| Secondary | Pharmacokinetic (PK) Parameters: Median of Trough Concentrations of Denosumab | Days 1, 8, 15, and 22 of course 1, day 1 of courses 2-4 and 7, and days 1 and 15 of course 6 | Sample medians of trough concentrations of denosumab will be calculated. |
| Secondary | Pharmacodynamic (PD) Parameters of Denosumab: Serum C-telopeptide | Days 1, 8, 15, and 22 of course 1 and day 1 of courses 2-4 and 7 | Serum c-telopeptide in pg/ml |
| Secondary | Pharmacodynamic (PD) Parameters of Denosumab: Urine N-telopeptide to Creatinine Ratio | Days 1, 8, 15, and 22 of course 1 and day 1 of courses 2-4 and 7 | Urine n-telopeptide to creatinine ratio expressed as nMol BCE/mmol creatinine |
| Secondary | Incidence of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Minimum of 2 years | The number of cycles where a dose-limiting toxicity was identified where dose-limiting toxicity is defined in the protocol using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 |
| Secondary | Response Rate (CR or PR) for Patients With Recurrent Osteosarcoma Limited to Bone (Cohort I) | Up to 3 years post-treatment | Confidence intervals will be constructed using the approximate normal distribution of each of the estimates and their asymptotic variances. |
| Secondary | Disease Control Rates for Patients With Recurrent Osteosarcoma Limited to Bone (Cohort I) | At 4 months | Confidence intervals will be constructed using the approximate normal distribution of each of the estimates and their asymptotic variances. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Control Rate (Cohort I) | At 4 months | 1 patient was excluded due to withdrawal. | participants | NUMBER |
| PRIMARY | Response Evaluation Criteria in Solid Tumors (RECIST) Response (Complete Response [CR] or Partial Response [PR] vs Not CR or PR) (Cohort I) | At 4 months | 1 patient was excluded due to withdrawal. | participants | NUMBER |
| PRIMARY | Disease Control Rate (Cohort II) | At 12 months | 2 patients were excluded due to ineligibility | participants | NUMBER |
| SECONDARY | Pharmacokinetic (PK) Parameters: Mean of Trough Concentrations of Denosumab | Days 1, 8, 15, and 22 of course 1, day 1 of courses 2-4 and 7, and days 1 and 15 of course 6 | The number of patients who contributed samples varied across cycles. | ng/ml | MEAN |
| SECONDARY | Pharmacokinetic (PK) Parameters: Median of Trough Concentrations of Denosumab | Days 1, 8, 15, and 22 of course 1, day 1 of courses 2-4 and 7, and days 1 and 15 of course 6 | The number of patients who contributed samples varied across cycles. | ng/ml | MEDIAN |
| SECONDARY | Pharmacodynamic (PD) Parameters of Denosumab: Serum C-telopeptide | Days 1, 8, 15, and 22 of course 1 and day 1 of courses 2-4 and 7 | All eligible participants | pg/ml | MEAN |
| SECONDARY | Pharmacodynamic (PD) Parameters of Denosumab: Urine N-telopeptide to Creatinine Ratio | Days 1, 8, 15, and 22 of course 1 and day 1 of courses 2-4 and 7 | All eligible participants | nMol BCE/mmol creatinine | MEAN |
| SECONDARY | Incidence of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Minimum of 2 years | 56 patients were treated on protocol therapy. Three hundred seventy-three cycles were reported for the analysis of dose limiting toxicity | cycles | NUMBER |
| SECONDARY | Response Rate (CR or PR) for Patients With Recurrent Osteosarcoma Limited to Bone (Cohort I) | Up to 3 years post-treatment | There were not any patients that met criteria for bone site | ||
| SECONDARY | Disease Control Rates for Patients With Recurrent Osteosarcoma Limited to Bone (Cohort I) | At 4 months | There were not any patients that met criteria for bone site |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group75
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Control Rate (Cohort I) | Cohort 1: Measurable | 1 | participants | ||
| Response Evaluation Criteria in Solid Tumors (RECIST) Response (Complete Response [CR] or Partial Response [PR] vs Not CR or PR) (Cohort I) | Cohort 1: Measurable | 0 | participants | ||
| Disease Control Rate (Cohort II) | Cohort 2: Resection | 10 | participants | ||
| Pharmacokinetic (PK) Parameters: Mean of Trough Concentrations of Denosumab | Cohort 1: Measurable | Serum denosumab (ng/ml): Cycle 1, Day 1 | 0 | Standard Deviation 0 | ng/ml |
| Pharmacokinetic (PK) Parameters: Mean of Trough Concentrations of Denosumab | Cohort 2: Resection | Serum denosumab (ng/ml): Cycle 1, Day 1 | 0 | Standard Deviation 0 | ng/ml |
| Pharmacokinetic (PK) Parameters: Mean of Trough Concentrations of Denosumab | Cohort 1: Measurable | Serum denosumab (ng/ml): Cycle 1, Day 8 | 11.59 | Standard Deviation 3.836665219 | ng/ml |
| Pharmacokinetic (PK) Parameters: Mean of Trough Concentrations of Denosumab | Cohort 2: Resection | Serum denosumab (ng/ml): Cycle 1, Day 8 | 10.81 | Standard Deviation 4.514421336 | ng/ml |
| Pharmacokinetic (PK) Parameters: Mean of Trough Concentrations of Denosumab | Cohort 1: Measurable | Serum denosumab (ng/ml): Cycle 1, Day 15 | 20.57 | Standard Deviation 8.290958931 | ng/ml |
| Pharmacokinetic (PK) Parameters: Mean of Trough Concentrations of Denosumab | Cohort 2: Resection | Serum denosumab (ng/ml): Cycle 1, Day 15 | 22.07 | Standard Deviation 10.0339424 | ng/ml |
| Pharmacokinetic (PK) Parameters: Mean of Trough Concentrations of Denosumab | Cohort 1: Measurable | Serum denosumab (ng/ml): Cycle 1, Day 22 | 31.8 | Standard Deviation 12.85573802 | ng/ml |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: Measurable | 16 | |
| Overall Study | STARTED | Cohort 2: Resection | 40 | |
| Overall Study | Follow-up Report | Cohort 1: Measurable | 1 | |
| Overall Study | Follow-up Report | Cohort 2: Resection | 10 | |
| Overall Study | COMPLETED | Cohort 1: Measurable | 15 | |
| Overall Study | COMPLETED | Cohort 2: Resection | 38 | |
| Overall Study | NOT COMPLETED | Cohort 1: Measurable | 1 | |
| Overall Study | NOT COMPLETED | Cohort 2: Resection | 2 |
Source ClinicalTrials.gov
Adverse events58
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymphocyte count decreased | Investigations | Cohort 1: Measurable | 1 | 15 | 1 |
| other | Lymphocyte count decreased | Investigations | Cohort 2: Resection | 0 | 38 | 0 |
| other | Weight gain | Investigations | Cohort 1: Measurable | 0 | 15 | 0 |
| other | Weight gain | Investigations | Cohort 2: Resection | 1 | 38 | 1 |
| other | Hypercalcemia | Metabolism and nutrition disorders | Cohort 1: Measurable | 0 | 15 | 0 |
| other | Hypercalcemia | Metabolism and nutrition disorders | Cohort 2: Resection | 1 | 38 | 1 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Cohort 1: Measurable | 1 | 15 | 1 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Cohort 2: Resection | 0 | 38 | 0 |
| other | Hypocalcemia | Metabolism and nutrition disorders | Cohort 1: Measurable | 0 | 15 | 0 |
| other | Hypocalcemia | Metabolism and nutrition disorders | Cohort 2: Resection | 1 | 38 | 1 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Measurable | 13 | 15 |
| Total, all-cause mortality | Cohort 2: Resection | 20 | 38 |
| Total, other adverse events | Cohort 1: Measurable | 1 | 15 |
| Total, other adverse events | Cohort 2: Resection | 8 | 38 |
| Total, serious adverse events | Cohort 1: Measurable | 6 | 15 |
| Total, serious adverse events | Cohort 2: Resection | 4 | 38 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1: Measurable vs Cohort 2: Resection: deaths from any cause | Trial comparisons |
| Cohort 1: Measurable vs Cohort 2: Resection: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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The record and each of its lists are JSON, twenty rows a page. No key.
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