Clinical trial · Interventional
Phase Ib/II Study of Efficacy and Safety of MEK162 and Panitumumab, in Adult mCRC Patients With Mutant or Wild-type RAS Tumors
A Phase Ib/II, Open-label, Multi-center, Dose Escalation Study of MEK162 in Combination With Panitumumab in Adult Patients With Mutant RAS or Wild-type RAS Metastatic Colorectal Cancer
NCT01927341CI-TRIAL-00050163completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 primary purpose of the phase Ib is to estimate the MTD/RPD2 and of the phase II is to assess the anti-tumor activity of MEK162 in combination with panitumumab.
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 |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEK162 | Drug | Binimetinib | ALIAS |
| Panitumumab | Drug | Panitumumab | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Phase Ib: Dose escalation
- description
- Phase Ib: Dose escalation.
- interventionNames
- Drug: MEK162
- Drug: Panitumumab
- type
- EXPERIMENTAL
- label
- Phase II: Patients with mutant RAS mCRC
- description
- Patients with mutant RAS mCRC who have not been pretreated with an EGFR inhibitor (EGFRi), including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy.
- interventionNames
- Drug: MEK162
- Drug: Panitumumab
- type
- EXPERIMENTAL
- label
- Phase II: Patients with acquired mutant RAS mCRC
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Metastatic colorectal cancer * Progression on or following standard therapy, or no standard therapy (phase Ib). Progression on or following at least 2-prior fluoropyrimidine-containing chemotherapy regimens (phase II) * Written documentation of mutant or wild-type RAS * Life expectancy ≥ 3 months * ECOG performance status ≤ 2 Exclusion Criteria: Phase II arms 1 and 4 only: previous treatment with cetuximab, panitumumab, and/or other EGFR inhibitors * Previous treatment with MEK-inhibitors * History of severe infusion reactions to monoclonal antibodies. * Symptomatic or untreated leptomeningeal disease * Symptomatic brain metastasis * Current evidence of retinal disease; history of CSR, RVO or ophthalmopathy as assessed by ophthalmologic examination at baseline that would be considered a risk factor for CSR/RVO and history of keratitis. * Acute or chronic pancreatitis * Clinically significant cardiac disease * Not adequate hematologic, renal and hepatic function
References
Publications (1)
- DERIVEDVan Cutsem E, Yaeger R, Delord JP, Tabernero J, Siu LL, Ducreux M, Siena S, Elez E, Kasper S, Zander T, Steeghs N, Murphy D, Edwards M, Wainberg ZA. Phase Ib/II Study of the Efficacy and Safety of Binimetinib (MEK162) Plus Panitumumab for Mutant or Wild-Type RAS Metastatic Colorectal Cancer. Oncologist. 2023 Dec 11;28(12):e1209-e1218. doi: 10.1093/oncolo/oyad210. PMID 37597246