Clinical trial · Interventional
A Trial of Dalotuzumab in Combination With Irinotecan Versus Cetuximab and Irinotecan for Participants With Metastatic Rectal Cancers (mRC) (MK-0646-025)
A Phase IIA Open Label, Adaptive, Randomized Clinical Trial of Dalotuzumab (MK-0646) Treatment in Combination With Irinotecan Versus Cetuximab and Irinotecan for Patients With Metastatic Rectal Cancers (mRC) Expressing High IGF-1/Low IGF-2 Levels
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This trial was halted prematurely for business reasons and low enrollment.
Summary
Brief summary (as posted)
The purpose of this adaptive trial is to compare the progression-free survival of participants with metastatic rectal carcinoma when treated with intravenous (IV) dalotuzumab (MK-0646) + irinotecan therapy relative to participants treated with IV cetuximab + irinotecan. The primary hypothesis is that administration of dalotuzumab in combination with irinotecan to participants with wild-type KRAS metastatic rectal carcinoma with high insulin growth factor (IGF)-1/low IGF-2 expression levels improves progression-free survival compared to patients treated with cetuximab in combination with irinotecan.
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 |
|---|---|---|---|
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| Dalotuzumab | Drug | — | UNRESOLVED |
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Dalotuzumab + Irinotecan
- description
- Participants receive irinotecan intravenously (IV), 180 mg/m\^2 once every two weeks + dalotuzumab IV, 10 mg/kg once weekly, during ≥1 42-day treatment cycle(s).
- interventionNames
- Drug: Dalotuzumab
- Drug: Irinotecan
- type
- ACTIVE_COMPARATOR
- label
- Arm B: Cetuximab + Irinotecan
- description
- Participants receive cetuximab IV, initial dose of 400 mg/m\^2 and then 250 mg/m\^2 IV weekly + irinotecan IV, 180 mg/m\^2 once every two weeks, during ≥1 42-day treatment cycle(s).
- interventionNames
- Drug: Irinotecan
- Drug: Cetuximab
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Has metastatic colorectal cancer with primary tumor originating from the rectum * Has an available archival (recent or remote) tumor, or newly obtained formalin-fixed tissue available for analysis for biomarker studies * Has at least one measurable lesion greater than or equal to 10 mm * Disease has progressed after treatment with both irinotecan- and oxaliplatin-containing regimens and should have progressed on or within 3 months of completing their last line of therapy * Has a performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale Exclusion Criteria: * Has poorly-controlled diabetes * Has received chemotherapy or biological therapy within 2 weeks prior to initial dosing on this study, or whose toxicities from agents administered 2 weeks earlier have not resolved to at least grade 1 or baseline, or who is within 3 weeks from a prior surgery * Has received radiotherapy within 2 weeks prior to initial dosing on this study, unless the radiotherapy was for management of pain * Is currently participating or has participated in a study with an investigational compound or device within 30 days or 5 half-lives of the investigational agent, whichever is longer, of initial dosing on this study * Was unable to complete previous course of irinotecan due to intolerable toxicity, other than discontinuation due to fatigue following prolonged administration (\>4 months exposure) * Has prior exposure to insulin-like growth factor 1 receptor (IGF-1R) inhibitors or epidermal growth factor receptor (EGFR) inhibitors * Has a known central nervous system (CNS) metastases and/or carcinomatous meningitis * Has primary CNS tumor * Has a history of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localized prostate carcinoma; potentially curative therapy with no evidence of that disease for 5 years, deemed low risk for recurrence by treating physician. * Is human immunodeficiency virus (HIV)-positive * Has active hepatitis B or C infection and is receiving antiviral treatment regimens * Has symptomatic ascites or pleural effusion * Is concurrently using growth hormone (GH), or growth hormone inhibitors
References
Publications (0)
Data not yet available