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The study was prematurely terminated for strategic reasons, not for a safety concern.
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Participants with relapsed osteosarcoma that can be treated with surgery will be randomized to robatumumab administered intravenously (IV) at one of two dose levels. These participants will first receive robatumumab, have surgery performed, and continue to receive treatment every two weeks until a year of dosing, or until disease progression.
Participants with unresectable osteosarcoma or Ewing Sarcoma will receive robatumumab IV once every two weeks until disease progression. Participants who achieve a complete response (CR) or partial response (PR) after tumor evaluations may undergo surgical resection. After surgery, participants are eligible to receive 10 mg/kg robatumumab until disease recurrence/progression or one year of total dosing, whichever occurs first.
Participants with resectable osteosarcoma will be randomized to one of two dose levels of robatumumab to be given intravenously. These participants will first receive robatumumab according to randomized treatment, and have surgery performed 10 to 14 days after initial dosing. Participants will be allowed to recover from surgery four to six weeks prior to additional robatumumab administration at their randomized dose level. robatumumab will then be administered on the same calendar day once every two weeks. Participants will continue to receive robatumumab until disease recurrence, or until completing a year of dosing at the same dose level assigned, whichever occurs first.
Participants with unresectable osteosarcoma or Ewing Sarcoma will be assigned treatment to robatumumab IV administered once every two weeks and will continue to receive robatumumab until disease progression. Participants who achieve a CR or PR after tumor evaluations may undergo surgical resection. After surgery, participants are eligible to receive 10 mg/kg robatumumab until disease recurrence/progression or one year of total dosing, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: 0.3 mg/kg | Experimental | Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin. |
|
| Group 1: 10 mg/kg | Experimental | Participants who received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin. |
|
| Group 2: 10 mg/kg | Experimental | Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen. |
|
| Group 3: 10 mg/kg | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| robatumumab | Biological | Robatumumab IV every two weeks until disease progression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving a Complete Response or Partial Response (Group 3 Only) | This is a measure of the number of participants with a complete response (CR) or partial response (PR) to therapy, confirmed by central review. Response was based on Response Evaluation Criteria in Solid Tumors (RECIST) and World Health Organization (WHO) criteria. | Up to 1 year following the start of study therapy |
| Number of Participants With >= 25% Change in Tumor Proliferation After Exposure to Robatumumab (Group 1 Only) | Tumor proliferation was measured using Ki-67 levels. Ki-67 is nuclear protein associated with cellular proliferation. | Approximately 14 days |
| Number of Participants Achieving a Complete Response, a Partial Response, or Stable Disease (Group 2 Only) | Responses to treatment (complete response, partial response, or stable disease) confirmed by central review for Participants in Group 2. Response was based on Response Evaluation Criteria in Solid Tumors (RECIST) and World Health Organization (WHO) criteria. | Up to 1 year following the start of study therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | This is a measure of the number of participants known to be alive at the time of data analysis for this study. | From start of treatment until death or data analysis cut off (Up to 3.4 years) |
| Time Until Tumor Relapse (Group 1 Only) |
Not provided
Inclusion Criteria:
A participant must be 11 years of age or older and may be of any race, and gender; participants between 4 and 10 years of age, inclusive, may be considered on a site-by-site basis.
A participant must have a diagnosis of histologically confirmed osteosarcoma or Ewing sarcoma;
A participant with either:
A participant >16 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of <=2; a participant <=16 years of age must have a Karnofsky performance status between 50% and 100% or a Lansky play scale between 50% and 100%
A participant must have adequate organ function.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27362300 | Result | Anderson PM, Bielack SS, Gorlick RG, Skubitz K, Daw NC, Herzog CE, Monge OR, Lassaletta A, Boldrini E, Papai Z, Rubino J, Pathiraja K, Hille DA, Ayers M, Yao SL, Nebozhyn M, Lu B, Mauro D. A phase II study of clinical activity of SCH 717454 (robatumumab) in patients with relapsed osteosarcoma and Ewing sarcoma. Pediatr Blood Cancer. 2016 Oct;63(10):1761-70. doi: 10.1002/pbc.26087. Epub 2016 Jun 30. | |
| 22682017 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: 0.3 mg/kg | Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
|
|
This is a measure of the time from the start of the study to documented relapse of disease.
| From start of treatment until relapse or data analysis cut off (Up to 3.4 years) |
| Area Under the Concentration-time Curve (AUC) of Serum Levels of Robatumumab (Group 1 Only) | End of infusion on Day 1, and then prior to surgery, before and after the 2nd, 3rd, and 8th doses (up to 20 weeks) |
| Incidence of Anti-robatumumab Antibodies | For biological agents, it is possible for the host (participant) to develop antibodies to the agent. This outcome measure was planned to find out the number of participants who developed the antibodies after treatment with robatumumab. | Up to 2 years |
| Number of Participants Experiencing Treatment-Emergent Adverse Events | An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. Treatment-emergent adverse events are those that occur after participants have received study treatment, or existing adverse events that occurred during screening that increase in severity after study treatment. Adverse events in the Group 1: 0.3 mg/kg arm that occurred after switching to the 10 mg/kg dose are displayed under the originally assigned treatment. | Up to 2 years |
| Time to Disease Progression (Groups 2 and 3 Only) | This is a measure of the time from the start of the study to the time of documented disease progression. | From the start of treatment until disease progression or data analysis cut off (Up to 3.4 years) |
| Overall Survival (Groups 2 and 3 Only) | This is a measure of the time of survival from first dose to documentation of death | From start of treatment until death or data analysis cut off (Up to 3.4 years) |
| Duration of Response (Groups 2 and 3 Only) | This is a measure of the amount of time in which the tumor responded to therapy. | From time of documented response until disease progression or data analysis cut off (Up to 3.4 years) |
| Derived |
| Asmane I, Watkin E, Alberti L, Duc A, Marec-Berard P, Ray-Coquard I, Cassier P, Decouvelaere AV, Ranchere D, Kurtz JE, Bergerat JP, Blay JY. Insulin-like growth factor type 1 receptor (IGF-1R) exclusive nuclear staining: a predictive biomarker for IGF-1R monoclonal antibody (Ab) therapy in sarcomas. Eur J Cancer. 2012 Nov;48(16):3027-35. doi: 10.1016/j.ejca.2012.05.009. Epub 2012 Jun 7. |
| FG001 | Group 1: 10 mg/kg | Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin. |
| FG002 | Group 2: 10 mg/kg | Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen. |
| FG003 | Group 3: 10 mg/kg | Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine. |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Three participants did not receive study treatment but are included in the baseline population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: 0.3 mg/kg | Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin. |
| BG001 | Group 1: 10 mg/kg | Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin. |
| BG002 | Group 2: 10 mg/kg | Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen. |
| BG003 | Group 3: 10 mg/kg | Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Achieving a Complete Response or Partial Response (Group 3 Only) | This is a measure of the number of participants with a complete response (CR) or partial response (PR) to therapy, confirmed by central review. Response was based on Response Evaluation Criteria in Solid Tumors (RECIST) and World Health Organization (WHO) criteria. | Participants in Group 3 with evaluable data. | Posted | Number | Participants | Up to 1 year following the start of study therapy |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Participants With >= 25% Change in Tumor Proliferation After Exposure to Robatumumab (Group 1 Only) | Tumor proliferation was measured using Ki-67 levels. Ki-67 is nuclear protein associated with cellular proliferation. | Group 1 Participants; this outcome was not evaluated due to early termination of the study. | Posted | Approximately 14 days |
| ||||||||||||||||||||||||||||||
| Primary | Number of Participants Achieving a Complete Response, a Partial Response, or Stable Disease (Group 2 Only) | Responses to treatment (complete response, partial response, or stable disease) confirmed by central review for Participants in Group 2. Response was based on Response Evaluation Criteria in Solid Tumors (RECIST) and World Health Organization (WHO) criteria. | Group 2 participants with evaluable data. | Posted | Number | Participants | Up to 1 year following the start of study therapy |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival | This is a measure of the number of participants known to be alive at the time of data analysis for this study. | All study participants | Posted | Number | Participants | From start of treatment until death or data analysis cut off (Up to 3.4 years) |
| ||||||||||||||||||||||||||||
| Secondary | Time Until Tumor Relapse (Group 1 Only) | This is a measure of the time from the start of the study to documented relapse of disease. | Group 1 participants; this outcome was not evaluated due to early termination of the study. | Posted | From start of treatment until relapse or data analysis cut off (Up to 3.4 years) |
| ||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve (AUC) of Serum Levels of Robatumumab (Group 1 Only) | Group 1, both dose levels: this outcome was not evaluated due to early termination of the study. | Posted | End of infusion on Day 1, and then prior to surgery, before and after the 2nd, 3rd, and 8th doses (up to 20 weeks) |
| |||||||||||||||||||||||||||||||
| Secondary | Incidence of Anti-robatumumab Antibodies | For biological agents, it is possible for the host (participant) to develop antibodies to the agent. This outcome measure was planned to find out the number of participants who developed the antibodies after treatment with robatumumab. | This outcome was not evaluated due to early termination of the study. | Posted | Up to 2 years |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Treatment-Emergent Adverse Events | An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. Treatment-emergent adverse events are those that occur after participants have received study treatment, or existing adverse events that occurred during screening that increase in severity after study treatment. Adverse events in the Group 1: 0.3 mg/kg arm that occurred after switching to the 10 mg/kg dose are displayed under the originally assigned treatment. | All participants receiving study drug. | Posted | Number | Participants | Up to 2 years |
| ||||||||||||||||||||||||||||
| Secondary | Time to Disease Progression (Groups 2 and 3 Only) | This is a measure of the time from the start of the study to the time of documented disease progression. | All participants in Groups 2 and 3; this outcome was not evaluated due to early termination of the study | Posted | From the start of treatment until disease progression or data analysis cut off (Up to 3.4 years) |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival (Groups 2 and 3 Only) | This is a measure of the time of survival from first dose to documentation of death | Group 2 and 3 Participants | Posted | Median | 95% Confidence Interval | Months | From start of treatment until death or data analysis cut off (Up to 3.4 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (Groups 2 and 3 Only) | This is a measure of the amount of time in which the tumor responded to therapy. | Group 2 and 3 participants; this outcome was not evaluated due to early termination of the study | Posted | From time of documented response until disease progression or data analysis cut off (Up to 3.4 years) |
|
|
Adverse events are reported from enrollment up to 5 weeks after the end of treatment (up to 2 years)
All treated participants; adverse events in the Group 1: 0.3 mg/kg arm that occurred after switching to the 10 mg/kg dose are displayed under the originally assigned treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: 0.3mg/kg | Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin. | 17 | 34 | 28 | 34 | ||
| EG001 | Group 1: 10mg/kg | Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin. | 8 | 33 | 30 | 33 | ||
| EG002 | Group 2: 10mg/kg | Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen. | 12 | 34 | 29 | 34 | ||
| EG003 | Group 3: 10mg/kg | Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine. | 57 | 115 | 104 | 115 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| FEBRILE BONE MARROW APLASIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| APLASIA | Congenital, familial and genetic disorders | MedDRA 14.0 | Systematic Assessment |
| |
| BLINDNESS UNILATERAL | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| GASTROINTESTINAL PAIN | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| RETROPERITONEAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| CONDITION AGGRAVATED | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DEVICE DISLOCATION | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DRUG WITHDRAWAL SYNDROME | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HYPERTHERMIA | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| MULTI-ORGAN FAILURE | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PERFORMANCE STATUS DECREASED | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HEPATIC HAEMORRHAGE | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| JAUNDICE | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| BRONCHOPNEUMONIA | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| CENTRAL NERVOUS SYSTEM INFECTION | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| OTITIS MEDIA | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| PNEUMONIA VIRAL | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| POST PROCEDURAL INFECTION | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| BRAIN HERNIATION | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| POSTOPERATIVE RESPIRATORY DISTRESS | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| PROCEDURAL HYPOTENSION | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| WOUND NECROSIS | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| BIOPSY BONE ABNORMAL | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| BLOOD POTASSIUM DECREASED | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| BURSITIS | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HYPERCREATINAEMIA | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| CANCER PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| MALIGNANT PLEURAL EFFUSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| METASTASES TO LUNG | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| OSTEOSARCOMA RECURRENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| ALTERED STATE OF CONSCIOUSNESS | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| COMA | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| CONVULSION | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ENCEPHALOPATHY | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HEPATIC ENCEPHALOPATHY | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| MENINGEAL DISORDER | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| MYOCLONUS | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| NERVE COMPRESSION | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| SPINAL CORD COMPRESSION | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| TOXIC ENCEPHALOPATHY | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| AGITATION | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| BRONCHIAL DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DYSPNOEA AT REST | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HAEMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PULMONARY TOXICITY | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PETECHIAE | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| LEG AMPUTATION | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
| |
| MEDICAL DEVICE REMOVAL | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
| |
| THORACOTOMY | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
| |
| WOUND TREATMENT | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
| |
| HAEMORRHAGE | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| SHOCK HAEMORRHAGIC | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| SINUS TACHYCARDIA | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| TINNITUS | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| INCISION SITE PAIN | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| POST-THORACOTOMY PAIN SYNDROME | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| HAEMOGLOBIN DECREASED | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PAIN IN JAW | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| WHEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| SUBCUTANEOUS EMPHYSEMA | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
The study was stopped prematurely for administrative reasons; not all planned endpoints were analyzed.
The Investigator agrees not to publish or publicly present any interim results of the study without the prior written consent of the Sponsor. The Investigator further agrees to provide to the Sponsor 45 days prior to submission any publication, presentation, abstracts, manuscripts, or electronic media that report any results of the study. The Sponsor shall have the right to review and comment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| D012512 | Sarcoma, Ewing |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| C573312 | robatumumab |
Not provided
Not provided
Not provided
| Male |
|
|
|
| OG002 | Group 2: 10 mg/kg | Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen. |
| OG003 | Group 3: 10 mg/kg | Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
| OG002 | Group 2: 10 mg/kg | Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen. |
| OG003 | Group 3: 10 mg/kg | Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine. |
|
| OG002 | Group 2: 10 mg/kg | Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen. |
| OG003 | Group 3: 10 mg/kg | Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine. |
|
|
|