Phase 2
N=110
MEK162 for Patients With RAS/RAF/MEK Activated Tumors
Solid Tumor and Hematologic Malignancies
Bottom Line
View on ClinicalTrials.gov: NCT01885195 ↗Enrolled (actual)
110
Serious AEs
45.5%
Results posted
Feb 2021
Primary outcome: Primary: Clinical Benefit Rate (CBR) for Solid Tumors at Week 16 as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 — 23.1 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MEK162 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Benefit Rate (CBR) for Solid Tumors at Week 16 as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |
23.1 | — |
| PRIMARY CBR for Hematologic Tumors at Week 16: Multiple Myeloma |
0.0 | — |
| PRIMARY CBR for Hematologic Tumors at Week 16: Acute Myeloid Leukemia |
33.3 | — |
| SECONDARY Overall Response Rate (ORR) as Per RECIST Version 1.1 |
2.9 | — |
| SECONDARY ORR for Hematologic Tumors: Multiple Myeloma |
33.3 | — |
| SECONDARY ORR for Hematologic Tumors: Acute Myeloid Leukemia |
33.3 | — |
| SECONDARY Progression-free Survival (PFS) as Per RECIST Version 1.1 |
2.6 | — |
| SECONDARY Overall Survival (OS) |
8.5 | — |
| SECONDARY Duration of Response (DOR) as Per RECIST Version 1.1 |
NA | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 |
2; 27; 64; 17 | — |
| SECONDARY Number of Participants With Vital Sign Abnormality of Greater Than or Equal to (>=) Grade 3 as Per CTCAE v4.03 |
15; 6; 11 | — |
| SECONDARY Number of Participants With Electrocardiogram (ECG) Abnormalities |
15; 4; 1; 20; 3; 13 | — |
| SECONDARY Number of Participants With Shift From Baseline in Clinical Laboratory - Hematology Parameters |
6; 3; 2; 2; 2; 0 | — |
| SECONDARY Number of Participants With Shift From Baseline in Clinical Laboratory - Biochemistry Parameters |
0; 1; 5; 1; 2; 2 | — |
| SECONDARY Number of Participants With Shift From Baseline in Cardiac Imaging |
10 | — |
Summary
The purpose of this signal seeking study is to determine whether treatment with MEK162 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study
Eligibility Criteria
Inclusion Criteria
- Patient has a confirmed diagnosis of a select solid tumor (except for primary diagnosis of pancreatic cancer, biliary cancer, colorectal cancer, low grade serous ovarian cancer, melanoma) or hematologic malignancy (except for primary diagnosis of chronic myelomonocytic leukemia).
- Patients must be pre-identified as having a tumor with a mutation in RAF, RAS, NF1 or MEK at a CLIA certified laboratory
- Patient must have received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.
- Patient must have progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines.
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Exclusion Criteria
- Patient has received prior treatment with MEK162.
- Patients with primary CNS tumor or CNS tumor involvement
- History of retinal degenerative disease
- History or current evidence of central serous retinopathy (CSR) or retinal vein occlusion (RVO)
- Any ophthalmopathy visible at screening that would be considered a risk factor for CSR or RVO by the ophthalmologist
- Patients who have neuromuscular disorders that are associated with elevated CK
Data sourced from ClinicalTrials.gov (NCT01885195). 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.