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A Study to Determine the Activity of Robatumumab (SCH 717454) in Participants With Relapsed Osteosarcoma or Ewing's Sarcoma (MK-7454-002/P04720)
Phase 2 trial testing robatumumab in Osteosarcoma in 219 participants. Terminated before completion.
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 219 |
| Start date | 1 February 2008 |
| Primary completion | 31 August 2011 |
| Estimated completion | 31 August 2013 |
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4 and older, any sex, with Osteosarcoma or Sarcoma, Ewing's. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Group 3: 10 mg/kg | 6 |
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 | Value | 95% CI |
|---|---|---|
| Group 2: 10 mg/kg | 6 |
This is a measure of the number of participants known to be alive at the time of data analysis for this study.
| Group | Value | 95% CI |
|---|---|---|
| Group 1: 0.3 mg/kg | 17 | |
| Group 1: 10 mg/kg | 16 | |
| Group 2: 10 mg/kg | 7 | |
| Group 3: 10 mg/kg | 28 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Group 1: 0.3 mg/kg | 31 | |
| Group 1: 10 mg/kg | 30 | |
| Group 2: 10 mg/kg | 31 | |
| Group 3: 10 mg/kg | 112 |
This is a measure of the time of survival from first dose to documentation of death
| Group | Value | 95% CI |
|---|---|---|
| Group 2: 10 mg/kg | 8.18 | 2.96 – 10.58 |
| Group 3: 10 mg/kg | 6.93 | 4.93 – 11.10 |
Time frame: Adverse events are reported from enrollment up to 5 weeks after the end of treatment (up to 2 years). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Group 1: 0.3mg/kg | Group 1: 10mg/kg | Group 2: 10mg/kg | Group 3: 10mg/kg |
|---|---|---|---|---|---|
| PAIN | General disorders | — | — | — | — |
| PYREXIA | General disorders | — | — | — | — |
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | — | — | — | — |
| CHEST PAIN | General disorders | — | — | — | — |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| ANAEMIA | Blood and lymphatic system disorders | — | — | — | — |
| ABDOMINAL PAIN | Gastrointestinal disorders | — | — | — | — |
| BACK PAIN | Musculoskeletal and connective tissue disorders | — | — | — | — |
| TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | — | — | — | — |
| CONSTIPATION | Gastrointestinal disorders | — | — | — | — |
| VOMITING | Gastrointestinal disorders | — | — | — | — |
| PNEUMONIA | Infections and infestations | — | — | — | — |
| DECREASED APPETITE | Metabolism and nutrition disorders | — | — | — | — |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | — | — | — | — |
| ENCEPHALOPATHY | Nervous system disorders | — | — | — | — |
| SPINAL CORD COMPRESSION | Nervous system disorders | — | — | — | — |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| FEBRILE BONE MARROW APLASIA | Blood and lymphatic system disorders | — | — | — | — |
| ATRIAL FIBRILLATION | Cardiac disorders | — | — | — | — |
| CARDIAC FAILURE | Cardiac disorders | — | — | — | — |
| Reaction | System | Group 1: 0.3mg/kg | Group 1: 10mg/kg | Group 2: 10mg/kg | Group 3: 10mg/kg |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | — | — | — | — |
| CONSTIPATION | Gastrointestinal disorders | — | — | — | — |
| DIARRHOEA | Gastrointestinal disorders | — | — | — | — |
| DECREASED APPETITE | Metabolism and nutrition disorders | — | — | — | — |
| VOMITING | Gastrointestinal disorders | — | — | — | — |
| HEADACHE | Nervous system disorders | — | — | — | — |
| FATIGUE | General disorders | — | — | — | — |
| ANAEMIA | Blood and lymphatic system disorders | — | — | — | — |
| PYREXIA | General disorders | — | — | — | — |
| INSOMNIA | Psychiatric disorders | — | — | — | — |
| ANXIETY | Psychiatric disorders | — | — | — | — |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | — | — | — | — |
| COUGH | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| BACK PAIN | Musculoskeletal and connective tissue disorders | — | — | — | — |
| ASTHENIA | General disorders | — | — | — | — |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | — | — | — | — |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | — | — | — | — |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | — | — | — | — |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | — | — | — | — |
| WEIGHT DECREASED | Investigations | — | — | — | — |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | — | — | — | — |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| RASH | Skin and subcutaneous tissue disorders | — | — | — | — |
| CHEST PAIN | General disorders | — | — | — | — |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | — | — | — | — |
| ABDOMINAL PAIN | Gastrointestinal disorders | — | — | — | — |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | — | — | — | — |
| PAIN | General disorders | — | — | — | — |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | — | — | — | — |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| URINARY TRACT INFECTION | Infections and infestations | — | — | — | — |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | — | — | — | — |
| TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | — | — | — | — |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | — | — | — | — |
| DIZZINESS | Nervous system disorders | — | — | — | — |
| SOMNOLENCE | Nervous system disorders | — | — | — | — |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| NEUTROPENIA | Blood and lymphatic system disorders | — | — | — | — |
Most-reported serious reactions: PAIN, PYREXIA, RESPIRATORY DISTRESS, RESPIRATORY FAILURE, THROMBOCYTOPENIA, CHEST PAIN, PNEUMOTHORAX, ANAEMIA.
Data from ClinicalTrials.gov NCT00617890 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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