Phase 2
Completed N=558
Study of Dalotuzumab (MK-0646) in Combination With Cetuximab and Irinotecan in Metastatic Colorectal Cancer (MK-0646-004)
Source: ClinicalTrials.gov NCT00614393 ↗Enrolled (actual)
558
Serious AEs
45.9%
Results posted
Dec 2016
Primary outcomePrimary: Overall Survival (OS) — 10.8; 11.6; 14.0 Months — p=0.06
Summary
This study will compare the safety and efficacy of dalotuzumab (MK-0646) in combination with cetuximab and irinotecan in treating participants with wild type KRAS (wtKRAS) metastatic colorectal cancer (CRC) compared to cetuximab and irinotecan alone.
The primary study hypothesis is that administration of dalotuzumab in combination with cetuximab and irinotecan to participants with metastatic CRC expressing the wtKRAS genotype improves Overall Survival OR Progression-free Survival compared to participants treated with cetuximab and irinotecan alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
10.8; 11.6; 14.0 | 0.06 |
| PRIMARY Progression-free Survival (PFS) |
3.9; 5.4; 5.6 | 0.07 |
| PRIMARY Percentage of Participants Who Have a Clinical or Laboratory Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 to 5 Toxicity |
82.8; 100.0; 90.0; 81.1; 75.8 | — |
| PRIMARY Percentage of Participants Who Have a Drug-related Clinical or Laboratory CTCAE Grade 3 to 5 Toxicity |
67.8; 100.0; 90.0; 72.8; 61.8 | — |
| PRIMARY Percentage of Participants Who Discontinue Study Drug Due to an AE |
11.1; 25.0; 30.0; 7.2; 11.8 | — |
| PRIMARY Percentage of Participants Who Experience an AE of Infusion Site Reaction |
0.0; 12.5; 0.0; 0.0; 0.0 | — |
| SECONDARY Overall Response Rate (ORR) of Dalotuzumab in Combination With Cetuximab + Irinotecan Versus ORR of Cetuximab + Irinotecan Alone in Participants With Wild Type of Colorectal Cancer |
21.6; 23.9; 26.1 | — |
Eligibility Criteria
Inclusion Criteria
- Participant must have confirmed wtKRAS CRC.
- Participant must have previously failed both irinotecan and oxaliplatin containing regimens, and should have progressed on or within 3 months of completing their last line of therapy with objective evidence of progression as verified by previous radiologic scans.
Exclusion Criteria
- Participant has had cancer treatment within 2 weeks before the first dose of study drug(s) or if the side effects from the drugs have not gone down to a certain level 2 weeks before the first dose of study drugs.
- Participant has had a bad side effect to irinotecan therapy.
- Participant has human immunodeficiency virus (HIV).
- Participant has Hepatitis B or C.
- Participant is pregnant or breast feeding or planning to have a child while on this study.
Data sourced from ClinicalTrials.gov (NCT00614393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.