Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma

Summary

The purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.

Eligibility

Inclusion Criteria:

* Must be ≥18 years of age
* Must have confirmed diagnosis according to AJCC staging as follows:

  * Metastatic pancreatic adenocarcinoma within 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

Conditions9

Interventions3

Locations28 sites

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