Phase 2
N=10
Phase Ib/II Study of Efficacy and Safety of MEK162 and Panitumumab, in Adult mCRC Patients With Mutant or Wild-type RAS Tumors
Metastatic Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01927341 ↗Enrolled (actual)
10
Serious AEs
47.2%
Results posted
Feb 2021
Primary outcome: Primary: Number of Participants With Dose-limiting Toxicities (DLT): Phase 1b — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MEK162 (Drug); Panitumumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-limiting Toxicities (DLT): Phase 1b |
— | — |
| PRIMARY Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Local Radiology Assessment: Phase 2 |
0; 0; 6.7; 0 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE) |
10; 15; 5; 15; 8; 3 | — |
| SECONDARY Number of Participants With Vital Sign Abnormalities |
0; 1; 1; 2; 0; 0 | — |
| SECONDARY Number of Participants With Electrocardiogram (ECG) Abnormalities |
3; 2; 1; 5; 1; 1 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Abnormalities |
0; 0; 0; 0; 0 | — |
| SECONDARY Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Local Radiology Assessment: Phase 1b |
— | — |
| SECONDARY Progression-free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Local Radiology Assessment |
3.4; 1.7; 1.8; 2.4; 2.1 | — |
| SECONDARY Duration of Response (DOR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Local Radiology Assessment |
5.3 | — |
| SECONDARY Disease Control Rate (DCR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Local Radiology Assessment |
70.0; 13.3; 40.0; 40.0; 37.5 | — |
| SECONDARY Overall Survival (OS) |
NA; 3.5; 5.5; 5.8; 11.2 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01927341). 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.