Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Robatumumab · 1 trial · 1 indication
FDG-PET was used in this study to detect the biological activity of modulation of the target within the tumor. Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 was used to select the target lesion. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs were identified as target lesions and recorded and measured at Baseline. The changes in SUVmax were calculated using the formula: (endpoint SUVmax - baseline SUVmax)/baseline SUVmax as a percentage. If multiple lesions had been measured at a visit, percentages calculated for all target lesions were averaged to find the decrease during the treatment period per participant. FDG SUVmax responder was defined as participants with \>20% decrease in SUVmax after the first cycle of robatumumab in Period 2.
| Arm | Type | Description |
|---|---|---|
| Robatumumab→Robatumumab | EXPERIMENTAL | Participants receive 1 dose of robatumumab 0.3 mg/kg intravenously (IV) followed by 1 dose of robatumumab 10 mg/kg IV once every 2 weeks (Q2W) until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles. |
| Chemotherapy→Robatumumab | ACTIVE_COMPARATOR | Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles. |
| Name | Type | Description |
|---|---|---|
| Robatumumab | BIOLOGICAL | - |
| Irinotecan | DRUG | - |
| Cetuximab | BIOLOGICAL | - |
| Capecitabine | DRUG | - |
| FOLFOX | DRUG | Leucovorin calcium (folinic acid)(FOL) + 5-fluorouracil (F)+ oxaliplatin (OX) |
| CAPEOX/XELOX | DRUG | Capecitabine (CAPE) or Xeloda® (XEL) + oxaliplatin (OX) |
| FOLFIRI | DRUG | Leucovorin calcium (folinic acid)(FOL) + 5-fluorouracil (F)+ irinotecan (IRI) |
Inclusion Criteria: * Older than 18 years of age, of any race, and gender; * Diagnosis of histologically confirmed relapsed or recurrent colorectal carcinoma that has progressed on at least first-line therapy; * Must have a computed tomography (CT) or magnetic resonance imaging (MRI) scan performed...
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Robatumumab is an investigational monoclonal antibody being studied for the treatment of colorectal cancer. It is being developed by Merck & Company, Inc. (MRK) and is currently in Phase 2 clinical development. The drug is intended for patients with relapsed or recurrent colorectal cancer.
Robatumumab is a monoclonal antibody, a type of targeted therapy that binds to specific proteins involved in cancer growth. Its exact molecular target has not been disclosed in available information. The drug is being evaluated for its activity in patients with relapsed or recurrent colorectal cancer.
Robatumumab is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 2 clinical trials for colorectal cancer.
Robatumumab is in Phase 2 clinical development for colorectal cancer. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed to evaluate its activity in patients with relapsed or recurrent colorectal cancer.
Robatumumab has been studied in one completed Phase 2 clinical trial with the identifier NCT00551213. This trial, titled 'A Study to Determine the Activity of Robatumumab (SCH 717454, MK-7454) in Participants With Relapsed or Recurrent Colorectal Cancer,' enrolled 67 participants aged 18 years and older.
Yes, Robatumumab is also known as SCH 717454 and MK-7454. These alternative names appear in clinical trial records, such as the Phase 2 study NCT00551213, which refers to the drug by all three names. This helps identify the same investigational agent across different sources.