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.

Interventions

• Atebimetinib · DRUG

  Once daily oral tablets

• GnP · DRUG

  Standard of care regimen for intravenous infusions of gemcitabine and nab-paclitaxel weekly for three weeks followed by one week without an infusion

• mGnP · DRUG

  Biweekly intravenous infusions of chemotherapy (gemcitabine and nab-paclitaxel)

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (38)

• City of Hope, Phoenix, Arizona · RECRUITING
• City of Hope, Duarte, California · RECRUITING
• Poudre Valley Health Care, Inc, Fort Collins, Colorado · RECRUITING
• Rocky Mountain Cancer Centers, Lone Tree, Colorado · RECRUITING
• Medical Oncology Hematology Consultants, Newark, Delaware · RECRUITING
• Hematology Oncology Associates of the Treasure Coast, Port Saint Lucie, Florida · RECRUITING
• Florida Cancer Specialists - South, Sarasota, Florida · RECRUITING
• Florida Cancer Specialists - North, St. Petersburg, Florida · RECRUITING
• Florida Cancer Specialists - East, West Palm Beach, Florida · RECRUITING
• Piedmont Cancer Institute, Atlanta, Georgia · RECRUITING
• Piedmont Healthcare, Atlanta, Georgia · RECRUITING
• Illinois Cancer Specialists, Arlington Heights, Illinois · RECRUITING
• City of Hope, Chicago, Illinois · RECRUITING
• OSF Medical Center, Peoria, Illinois · RECRUITING
• Maryland Oncology, Columbia, Maryland · RECRUITING
• Missouri Cancer Associates, Columbia, Missouri · RECRUITING
• Comprehensive Cancer Centers, Las Vegas, Nevada · RECRUITING
• Regional Cancer Care, Belleville, New Jersey · RECRUITING
• NYU Langone Health, New York, New York · RECRUITING
• FirstHealth of the Carolinas, Pinehurst, North Carolina · RECRUITING
• Taylor Cancer Research Center, Maumee, Ohio · RECRUITING
• Willamette Valley Cancer Institute, Eugene, Oregon · RECRUITING
• Thomas Jefferson University, Philadelphia, Pennsylvania · RECRUITING
• Avera Cancer Institute Research, Sioux Falls, South Dakota · RECRUITING
• West Cancer Center, Germantown, Tennessee · RECRUITING
• Sarah Cannon Research Institute, Nashville, Tennessee · RECRUITING
• Texas Oncology - West Texas, Abilene, Texas · RECRUITING
• Texas Oncology - Austin, Austin, Texas · RECRUITING
• Texas Oncology - San Antonio, San Antonio, Texas · RECRUITING
• Texas Oncology Gulf Coast, Webster, Texas · RECRUITING
• Blue Ridge Cancer Care, Blacksburg, Virginia · RECRUITING
• Virginia Cancer Specialists, Fairfax, Virginia · RECRUITING
• University of Washington Fred Hutchinson Cancer Center, Seattle, Washington · RECRUITING
• Northwest Cancer Specialists, Vancouver, Washington · RECRUITING
• University of Wisconsin Carbone Cancer Center, Madison, Wisconsin · RECRUITING
• Calvary Mater Newcastle, Waratah, New South Wales, Australia · RECRUITING
• Genesiscare, Waratah, New South Wales, Australia · RECRUITING
• Icon Cancer Centre - Chermside, Chermside, Queensland, Australia · RECRUITING