Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00551213 | A Study to Determine the Activity of Robatumumab (SCH 717454, MK-7454) in Participants With Relapsed or Recurrent Colorectal Cancer (P04721, MK-7454-003) | PHASE2 | COMPLETED | 67 | — | — | Nov 21, 2007 | Jun 4, 2009 | Aug 24, 2018 | - | — |
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...