Clinical trial · Interventional
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
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)
NCT07562152CI-TRIAL-00125900MAPKeeper 301recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Adenocarcinoma Metastatic | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer Metastatic | — | UNRESOLVED | — |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Ductal Adenocarcinoma (PDAC) | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.85 |
| PDAC | Pancreatic Ductal Adenocarcinoma | ALIAS | 0.90 |
| PDAC - Pancreatic Ductal Adenocarcinoma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atebimetinib | Drug | — | UNRESOLVED |
| GnP | Drug | — | UNRESOLVED |
| mGnP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Atebimetinib + mGnP
- description
- Atebimetinib in combination with modified gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma
- interventionNames
- Drug: Atebimetinib
- Drug: mGnP
- type
- ACTIVE_COMPARATOR
- label
- GnP
- description
- Standard of care gemcitabine and nab-paclitaxel for first line pancreatic adenocarcinoma
- interventionNames
- Drug: GnP
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Up to approximately 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.