Overview
The purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.
Description
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with atebimetinib plus a modified schedule of gemcitabine and nab-paclitaxel will improve overall survival compared with standard gemcitabine and nab-paclitaxel when given as first-line treatment in patients with metastatic pancreatic adenocarcinoma.
Patients will be randomized to one of two arms: Arm A with atebimetinib + gemcitabine and nab-paclitaxel (modified dosing schedule) or Arm B with gemcitabine and nab-paclitaxel.
Eligibility
Inclusion Criteria:
- Must be ≥18 years of age
- Must have confirmed diagnosis according to AJCC staging as follows:
- Metastatic pancreatic adenocarcinoma at least 12 weeks prior to screening
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Participants must be treatment naive as follows:
- First-line PDAC participants will have received no previous systemic anti-cancer therapy
- Must have evidence of measurable disease (at least one target lesion) per RECIST v1.1 criteria
- Adequate organ function, hepatic function, coagulation studies and protocol determined clinical laboratory values
Exclusion Criteria:
- Inability to swallow oral medications
- Participant has squamous, adenosquamous, neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma
- Participants with only locally advanced disease
- Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases
