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Recruiting NCT07562152

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

Phase III Interventional Pancreatic Cancer Pancreatic Cancer Metastatic PDAC PDAC - Pancreatic Ductal Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Atebimetinib, GnP, mGnP.
Who it may be relevant to
Registry conditions: Pancreatic Cancer, Pancreatic Cancer Metastatic, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3 Randomized, Open-Label Study of Atebimetinib in Combination With the Modified Gemcitabine and Nab-Paclitaxel Regimen Versus the Standard Gemcitabine and Nab-Paclitaxel Regimen for the Treatment of Patients With Metastatic Pancreatic Ductal Pancreatic Adenocarcinoma Cancer (MAPKeeper 301)

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.

Detailed 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.

Interventions

  • Drug Atebimetinib
    Once daily oral tablets
  • Drug GnP
    Standard of care regimen for intravenous infusions of gemcitabine and nab-paclitaxel weekly for three weeks followed by one week without an infusion
  • Drug mGnP
    Biweekly intravenous infusions of chemotherapy (gemcitabine and nab-paclitaxel)

Primary outcome measures

  • Overall Survival [Time frame: Up to approximately 2 years]
Secondary outcome measures (5)
  • Progression Free Survival (PFS) [Time frame: Up to approximately 2 years]
  • Overall Response Rate (ORR) [Time frame: Up to approximately 2 years]
  • Disease Control Rate (DCR) [Time frame: Up to approximately 2 years]
  • Incidence of Adverse Events (AEs) [Time frame: Up to approximately 2 years]
  • Quality of Life (QOL) with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [Time frame: Up to approximately 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 30 centers
  • City of Hope — Phoenix
  • City of Hope — Duarte
  • Poudre Valley Health Care, Inc — Fort Collins
  • Medical Oncology Hematology Consultants — Newark
  • Hematology Oncology Associates of the Treasure Coast — Port Saint Lucie
  • Florida Cancer Specialists - South — Sarasota
  • Florida Cancer Specialists - North — St. Petersburg
  • Florida Cancer Specialists - East — West Palm Beach
  • … and 22 more centers
Australia · 3 centers
  • Calvary Mater Newcastle — Waratah
  • Genesiscare — Waratah
  • Icon Cancer Centre - Chermside — Chermside

Identifiers

NCT: NCT07562152 · IMM1104-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗