A Study of MEK162 and AMG 479 in Patients With Selected Solid Tumors
Status:
Terminated
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
Summary
This is a multi-center, open-label, phase Ib/II study. First, the aim of the phase Ib part is
to estimate the MTD(s) and/or to identify the recommended phase II dose(s) (RP2D) for the
combination of MEK162 and AMG 479 (ganitumab), followed by the phase II part to assess the
clinical efficacy and to further assess the safety of the combination in selected patient
populations. The dose escalation part of the study will be guided by a Bayesian Logistic
Regression Model (BLRM). At least 18 patients are expected to be enrolled in the dose
escalation part.
Following MTD/ RP2D declaration, patients will be enrolled in three phase II arms to assess
efficacy of the combination as well as to better understand the safety, tolerability, PK,
antibody concentrations and PD of the combination at MTD/RP2D. Phase II arm 1 will consist of
approximately 25 patients with KRAS-mutant colorectal adenocarcinoma. Phase II arm 2 will
consist of approximately 20 patients with metastatic pancreatic adenocarcinoma. Phase II arm
3 will consist of approximately 28 patients with mutant BRAFV600 melanoma.
Patients will be treated until progression of disease, unacceptable toxicity develops, or
withdrawal of informed consent, whichever occurs first. All patients will be followed up - at
minimum patients must complete the safety follow-up assessments 30 days after the last dose
of the study treatment.