Clinical trial · Interventional
A Study to Determine the Activity of Robatumumab (SCH 717454, MK-7454) in Participants With Relapsed or Recurrent Colorectal Cancer (P04721, MK-7454-003)
A Fixed-Sequence, Open-Label Study to Determine the Activity of SCH 717454 as Assessed by Positron Emission Tomography in Subjects With Relapsed or Recurrent Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study was to determine the activity of two doses of robatumumab (SCH 717454, MK-7454) in participants with relapsed or recurrent colorectal cancer. The primary study hypothesis was that decreases in Positron Emission Tomography (PET)-assessed tumor glucose metabolism (i.e., fluorodeoxyglucose \[FDG\] standardized uptake value \[SUV\]) following administration of 10 mg/kg robatumumab will exceed those following administration of 0.3 mg/kg robatumumab in participants with relapsed or recurrent colorectal cancer who had progressed after first-line chemotherapy. Investigator choices of standard chemotherapy: irinotecan as a single agent +/- cetuximab OR capecitabine as a single agent, OR FOLFOX (leucovorin calcium \[folinic acid\]\[FOL\] + fluorouracil \[F\] + oxaliplatin \[OX\]) OR CAPEO(capecitabine \[CAPE\] or Xeloda® \[XEL\] + oxaliplatin \[OX\]) OR FOLFIRI (leucovorin calcium \[folinic acid\]\[FOL\] + fluorouracil \[F\] + irinotecan \[IRI\]) +/- cetuximab OR cetuximab as a single agent.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| CAPEOX/XELOX | Drug | — | UNRESOLVED |
| Cetuximab | Biological | Cetuximab | ALIAS |
| FOLFIRI | Drug | FOLFIRI Regimen | ALIAS |
| FOLFOX | Drug | FOLFOX Regimen | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Robatumumab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Robatumumab→Robatumumab
- description
- 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.
- interventionNames
- Biological: Robatumumab
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy→Robatumumab
- description
- 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.
- interventionNames
- Biological: Robatumumab
- Drug: Irinotecan
- Biological: Cetuximab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 at some point during their immediate prior treatment or observation in order to determine tumor growth rate; * Must have measurable disease on a CT or MRI study, performed during Screening; * Must have an Eastern Cooperative Oncology Group (ECOG) performance status of \<=2 and a minimum life expectancy of ≥4 months; * Must have adequate organ function within 3 weeks prior to treatment assignment Exclusion Criteria: * History of another malignancy; * Known treated or untreated leptomeningeal metastasis, or a metastatic central nervous system lesion; * Surgery within 3 weeks; * Radiation therapy within 6 weeks; * A history of uncontrolled diabetes mellitus, defined as a hemoglobin A1C of \>7.5% in a participant with known diabetes mellitus; * A recent myocardial infarction (within the past year); or a participant who at the time of Screening presents with unstable or uncontrolled angina, New York Heart Association Class III or IV congestive heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram abnormality; * An active infection; * Has clinically significant hepatitis at Screening, or is hepatitis C antibody positive, hepatitis B surface antigen positive, or human immunodeficiency virus (HIV) seropositive.
References
Publications (1)
- RESULTLin EH, Lenz HJ, Saleh MN, Mackenzie MJ, Knost JA, Pathiraja K, Langdon RB, Yao SL, Lu BD. A randomized, phase II study of the anti-insulin-like growth factor receptor type 1 (IGF-1R) monoclonal antibody robatumumab (SCH 717454) in patients with advanced colorectal cancer. Cancer Med. 2014 Aug;3(4):988-97. doi: 10.1002/cam4.263. Epub 2014 Jun 6. PMID 24905030