Trial Outcomes & Findings for Glembatumumab Vedotin in Treating Patients With Recurrent or Refractory Osteosarcoma (NCT NCT02487979)
NCT ID: NCT02487979
Last Updated: 2022-01-18
Results Overview
The number of patients who do not experience disease progression or death in the six cycles following enrollment on AOST1521
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
First six cycles (21-day cycle) of protocol therapy
Results posted on
2022-01-18
Participant Flow
Participant milestones
| Measure |
Treatment (Glembatumumab Vedotin)
Patients receive glembatumumab vedotin IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Glembatumumab Vedotin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
| Measure |
Treatment (Glembatumumab Vedotin)
Patients receive glembatumumab vedotin IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Glembatumumab Vedotin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Progressive Disease
|
17
|
Baseline Characteristics
Glembatumumab Vedotin in Treating Patients With Recurrent or Refractory Osteosarcoma
Baseline characteristics by cohort
| Measure |
Treatment (Glembatumumab Vedotin)
n=22 Participants
Patients receive glembatumumab vedotin IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Glembatumumab Vedotin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Age, Continuous
|
20.09 years
STANDARD_DEVIATION 5.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First six cycles (21-day cycle) of protocol therapyThe number of patients who do not experience disease progression or death in the six cycles following enrollment on AOST1521
Outcome measures
| Measure |
Treatment (Glembatumumab Vedotin)
n=22 Participants
Patients receive glembatumumab vedotin IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Glembatumumab Vedotin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Disease Control Success
|
3 Participants
|
SECONDARY outcome
Timeframe: Duration of protocol therapy - Up to two yearsPopulation: 22 patients were treated on protocol therapy. Sixty-one (61) cycles were reported for the analysis of toxicity.
The number of cycles aggregated across all patients where CTC Version 4 grade 3 or higher.
Outcome measures
| Measure |
Treatment (Glembatumumab Vedotin)
n=22 Participants
Patients receive glembatumumab vedotin IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Glembatumumab Vedotin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Toxicity Associated With Chemotherapy
Incidence of Abdominal Pain
|
2 cycles
|
|
Toxicity Associated With Chemotherapy
Incidence of acneiform rash
|
1 cycles
|
|
Toxicity Associated With Chemotherapy
Incidence of Anaphylaxis
|
1 cycles
|
|
Toxicity Associated With Chemotherapy
Incidence of Anemia
|
2 cycles
|
|
Toxicity Associated With Chemotherapy
Incidence of Anorexia
|
1 cycles
|
|
Toxicity Associated With Chemotherapy
Incidence of Back Pain
|
2 cycles
|
|
Toxicity Associated With Chemotherapy
Incidence of Constipation
|
1 cycles
|
|
Toxicity Associated With Chemotherapy
Incidence of Febrile Neutropenia
|
1 cycles
|
|
Toxicity Associated With Chemotherapy
Incidence of Headache
|
1 cycles
|
|
Toxicity Associated With Chemotherapy
Incidence of Hypertension
|
1 cycles
|
|
Toxicity Associated With Chemotherapy
Incidence of Hypocalcemia
|
1 cycles
|
|
Toxicity Associated With Chemotherapy
Incidence of Hypokalemia
|
4 cycles
|
|
Toxicity Associated With Chemotherapy
Incidence of Hypophosphatemia
|
2 cycles
|
|
Toxicity Associated With Chemotherapy
Incidence of Hypotension
|
1 cycles
|
|
Toxicity Associated With Chemotherapy
Incidence of Leukopenia
|
1 cycles
|
|
Toxicity Associated With Chemotherapy
Incidence of Lymphopenia
|
1 cycles
|
|
Toxicity Associated With Chemotherapy
Incidence of Mucocitis
|
2 cycles
|
|
Toxicity Associated With Chemotherapy
Incidence of Myalgia
|
1 cycles
|
|
Toxicity Associated With Chemotherapy
Incidence of Nausea
|
1 cycles
|
|
Toxicity Associated With Chemotherapy
Incidence of Neutropenia
|
2 cycles
|
|
Toxicity Associated With Chemotherapy
Incidence of Pain
|
2 cycles
|
|
Toxicity Associated With Chemotherapy
Incidence of Pneumothorax
|
1 cycles
|
|
Toxicity Associated With Chemotherapy
Incidence of Thrombocytopenia
|
1 cycles
|
SECONDARY outcome
Timeframe: Baseline to 24 hours post infusion on course 1Population: Samples were provided for four patients
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
Outcome measures
| Measure |
Treatment (Glembatumumab Vedotin)
n=4 Participants
Patients receive glembatumumab vedotin IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Glembatumumab Vedotin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Pharmacokinetics of Glembatumumab Vedotin: Total Antibody and Antibody-drug Conjugate Half-life
Total antibody half-life
|
35.2 hours
Standard Deviation 6.4
|
|
Pharmacokinetics of Glembatumumab Vedotin: Total Antibody and Antibody-drug Conjugate Half-life
Antibody-Drug Conjugate half-life
|
29.1 hours
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: Baseline to 24 hours post infusion on course 1Population: Samples were provided for four patients
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
Outcome measures
| Measure |
Treatment (Glembatumumab Vedotin)
n=4 Participants
Patients receive glembatumumab vedotin IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Glembatumumab Vedotin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Pharmacokinetics of Glembatumumab Vedotin: Total Antibody and Antibody-drug Conjugate Clearance
Total antibody clearance
|
0.8 millilitres per hour per kilogram
Standard Deviation 0.1
|
|
Pharmacokinetics of Glembatumumab Vedotin: Total Antibody and Antibody-drug Conjugate Clearance
Antibody-Drug Conjugate clearance
|
0.9 millilitres per hour per kilogram
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Baseline to 24 hours post infusion on course 1Population: Samples were provided for four patients
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
Outcome measures
| Measure |
Treatment (Glembatumumab Vedotin)
n=4 Participants
Patients receive glembatumumab vedotin IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Glembatumumab Vedotin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Pharmacokinetics of Glembatumumab Vedotin: Total Antibody and Antibody-drug Conjugate Areas Under the Curve
Total antibody area under the curve
|
2320.0 hour-microgram per millilitre
Standard Deviation 342
|
|
Pharmacokinetics of Glembatumumab Vedotin: Total Antibody and Antibody-drug Conjugate Areas Under the Curve
Antibody-Drug Conjugate area under the curve
|
2259.5 hour-microgram per millilitre
Standard Deviation 749.6
|
SECONDARY outcome
Timeframe: Prior to the time of enrollmentPopulation: Analysis was successfully completed for 19 patients
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.
Outcome measures
| Measure |
Treatment (Glembatumumab Vedotin)
n=19 Participants
Patients receive glembatumumab vedotin IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Glembatumumab Vedotin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Number of Participants With Glycoprotein NMB (GPNMB) Expression Stratified by Immunohistochemistry (IHC) Staining Strength
0+ staining strength
|
1 Participants
|
|
Number of Participants With Glycoprotein NMB (GPNMB) Expression Stratified by Immunohistochemistry (IHC) Staining Strength
1+ staining strength
|
3 Participants
|
|
Number of Participants With Glycoprotein NMB (GPNMB) Expression Stratified by Immunohistochemistry (IHC) Staining Strength
2+ staining strength
|
2 Participants
|
|
Number of Participants With Glycoprotein NMB (GPNMB) Expression Stratified by Immunohistochemistry (IHC) Staining Strength
3+ staining strength
|
13 Participants
|
SECONDARY outcome
Timeframe: First six cycles (21-day cycle) of protocol therapyThe 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.
Outcome measures
| Measure |
Treatment (Glembatumumab Vedotin)
n=22 Participants
Patients receive glembatumumab vedotin IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Glembatumumab Vedotin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
RECIST Response
|
1 Participants
|
Adverse Events
Treatment (Glembatumumab Vedotin)
Serious events: 8 serious events
Other events: 7 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Treatment (Glembatumumab Vedotin)
n=22 participants at risk
Patients receive glembatumumab vedotin IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Glembatumumab Vedotin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
2/22 • Number of events 2 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Gastrointestinal disorders
Constipation
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Gastrointestinal disorders
Mucositis oral
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
General disorders
Fever
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
General disorders
Pain
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Immune system disorders
Anaphylaxis
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Investigations
Neutrophil count decreased
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Investigations
Platelet count decreased
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Investigations
White blood cell decreased
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Metabolism and nutrition disorders
Acidosis
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.1%
2/22 • Number of events 2 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
2/22 • Number of events 2 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Nervous system disorders
Headache
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
13.6%
3/22 • Number of events 3 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Vascular disorders
Hypotension
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
Other adverse events
| Measure |
Treatment (Glembatumumab Vedotin)
n=22 participants at risk
Patients receive glembatumumab vedotin IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Glembatumumab Vedotin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Mucositis oral
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
General disorders
Pain
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Investigations
Lymphocyte count decreased
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Investigations
Neutrophil count decreased
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Nervous system disorders
Somnolence
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.1%
2/22 • Number of events 2 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Vascular disorders
Hypertension
|
4.5%
1/22 • Number of events 1 • Overall protocol therapy up to 14 months in total or 18 cycles, whichever occurs first.
Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
Additional Information
Results Reporting Coordinator
Children's Oncology Group
Phone: 626-447-0064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60