Trial · NCT02487979
Glembatumumab Vedotin in Treating Patients With Recurrent or Refractory Osteosarcoma
NCT02487979, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2018-10-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Glembatumumab Vedotin in Treating Patients With Recurrent or Refractory Osteosarcoma. Trials, record NCT02487979. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02487979
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Glembatumumab Vedotin in Treating Patients With Recurrent or Refractory Osteosarcoma
- NCT number
- NCT02487979
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Osteosarcoma
- Interventions
- Glembatumumab Vedotin, Laboratory Biomarker Analysis, Pharmacological Study
- First posted
- 2015-07-02
- Last updated
- 2022-01-18
- Results first posted
- 2018-10-15
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Control Success | First six cycles (21-day cycle) of protocol therapy | The number of patients who do not experience disease progression or death in the six cycles following enrollment on AOST1521 |
| Secondary | Toxicity Associated With Chemotherapy | Duration of protocol therapy - Up to two years | The number of cycles aggregated across all patients where CTC Version 4 grade 3 or higher. |
| Secondary | Pharmacokinetics of Glembatumumab Vedotin: Total Antibody and Antibody-drug Conjugate Half-life | Baseline to 24 hours post infusion on course 1 | Total antibody and antibody-drug conjugate half-life are estimated from the sampling time points: Before first dose (Baseline), end of infusion, at 1, 2, 4, and 24 hours post infusion |
| Secondary | Pharmacokinetics of Glembatumumab Vedotin: Total Antibody and Antibody-drug Conjugate Clearance | Baseline to 24 hours post infusion on course 1 | Total antibody and antibody-drug conjugate clearance are estimated from the sampling time points: Before first dose (Baseline), end of infusion, at 1, 2, 4, and 24 hours post infusion |
| Secondary | Pharmacokinetics of Glembatumumab Vedotin: Total Antibody and Antibody-drug Conjugate Areas Under the Curve | Baseline to 24 hours post infusion on course 1 | Total antibody and antibody-drug conjugate areas under the curve are estimated from the sampling time points: Before first dose (Baseline), end of infusion, at 1, 2, 4, and 24 hours post infusion |
| Secondary | Number of Participants With Glycoprotein NMB (GPNMB) Expression Stratified by Immunohistochemistry (IHC) Staining Strength | Prior to the time of enrollment | GPNMB expression by IHC of 0+ to 3+ staining strength as assessed on archived tumor specimens. 0 being no GPNMB expression and 3 indicating strong GPNMB expression. |
| Secondary | RECIST Response | First six cycles (21-day cycle) of protocol therapy | The number of patients who experience a complete or partial response according the RECIST criteria for target lesions complete response (CR) disappearance of all lesions; partial response (PR ) \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Control Success | First six cycles (21-day cycle) of protocol therapy | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Toxicity Associated With Chemotherapy | Duration of protocol therapy - Up to two years | 22 patients were treated on protocol therapy. Sixty-one (61) cycles were reported for the analysis of toxicity. | cycles | NUMBER |
| SECONDARY | Pharmacokinetics of Glembatumumab Vedotin: Total Antibody and Antibody-drug Conjugate Half-life | Baseline to 24 hours post infusion on course 1 | Samples were provided for four patients | hours | MEAN |
| SECONDARY | Pharmacokinetics of Glembatumumab Vedotin: Total Antibody and Antibody-drug Conjugate Clearance | Baseline to 24 hours post infusion on course 1 | Samples were provided for four patients | millilitres per hour per kilogram | MEAN |
| SECONDARY | Pharmacokinetics of Glembatumumab Vedotin: Total Antibody and Antibody-drug Conjugate Areas Under the Curve | Baseline to 24 hours post infusion on course 1 | Samples were provided for four patients | hour-microgram per millilitre | MEAN |
| SECONDARY | Number of Participants With Glycoprotein NMB (GPNMB) Expression Stratified by Immunohistochemistry (IHC) Staining Strength | Prior to the time of enrollment | Analysis was successfully completed for 19 patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | RECIST Response | First six cycles (21-day cycle) of protocol therapy | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Control Success | Treatment (Glembatumumab Vedotin) | 3 | Participants | ||
| Toxicity Associated With Chemotherapy | Treatment (Glembatumumab Vedotin) | Incidence of Abdominal Pain | 2 | cycles | |
| Toxicity Associated With Chemotherapy | Treatment (Glembatumumab Vedotin) | Incidence of acneiform rash | 1 | cycles | |
| Toxicity Associated With Chemotherapy | Treatment (Glembatumumab Vedotin) | Incidence of Anaphylaxis | 1 | cycles | |
| Toxicity Associated With Chemotherapy | Treatment (Glembatumumab Vedotin) | Incidence of Anemia | 2 | cycles | |
| Toxicity Associated With Chemotherapy | Treatment (Glembatumumab Vedotin) | Incidence of Anorexia | 1 | cycles | |
| Toxicity Associated With Chemotherapy | Treatment (Glembatumumab Vedotin) | Incidence of Back Pain | 2 | cycles | |
| Toxicity Associated With Chemotherapy | Treatment (Glembatumumab Vedotin) | Incidence of Constipation | 1 | cycles | |
| Toxicity Associated With Chemotherapy | Treatment (Glembatumumab Vedotin) | Incidence of Febrile Neutropenia | 1 | cycles | |
| Toxicity Associated With Chemotherapy | Treatment (Glembatumumab Vedotin) | Incidence of Headache | 1 | cycles |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Glembatumumab Vedotin) | 22 | |
| Overall Study | COMPLETED | Treatment (Glembatumumab Vedotin) | 1 | |
| Overall Study | NOT COMPLETED | Treatment (Glembatumumab Vedotin) | 21 |
Source ClinicalTrials.gov
Adverse events41
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 | Mucositis oral | Gastrointestinal disorders | Treatment (Glembatumumab Vedotin) | 1 | 22 | 1 |
| other | Nausea | Gastrointestinal disorders | Treatment (Glembatumumab Vedotin) | 1 | 22 | 1 |
| other | Pain | General disorders | Treatment (Glembatumumab Vedotin) | 1 | 22 | 1 |
| other | Infections and infestations - Other, specify | Infections and infestations | Treatment (Glembatumumab Vedotin) | 1 | 22 | 1 |
| other | Lymphocyte count decreased | Investigations | Treatment (Glembatumumab Vedotin) | 1 | 22 | 1 |
| other | Neutrophil count decreased | Investigations | Treatment (Glembatumumab Vedotin) | 1 | 22 | 1 |
| other | Anorexia | Metabolism and nutrition disorders | Treatment (Glembatumumab Vedotin) | 1 | 22 | 1 |
| other | Hypokalemia | Metabolism and nutrition disorders | Treatment (Glembatumumab Vedotin) | 1 | 22 | 1 |
| other | Hypophosphatemia | Metabolism and nutrition disorders | Treatment (Glembatumumab Vedotin) | 1 | 22 | 1 |
| other | Somnolence | Nervous system disorders | Treatment (Glembatumumab Vedotin) | 1 | 22 | 1 |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Glembatumumab Vedotin) | 14 | 22 |
| Total, other adverse events | Treatment (Glembatumumab Vedotin) | 7 | 22 |
| Total, serious adverse events | Treatment (Glembatumumab Vedotin) | 8 | 22 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02487979
GET https://conductscience.org/api/trials/v1/NCT02487979/results?page=2