Clinical trial · Interventional
Study Of PF-03084014 In Combination With Gemcitabine And Nab-Paclitaxel In Patients With Metastatic Pancreatic Adenocarcinoma Not Previously Treated With Anticancer Therapies
PHASE 1/2 STUDY OF PF-03084014 IN COMBINATION WITH GEMCITABINE AND NAB-PACLITAXEL IN PATIENTS WITH PREVIOUSLY UNTREATED METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated on 24JUN15 due to change in strategy of PF-03084014 development.No safety/efficacy concerns were behind the reason of trial termination
Summary
Brief summary (as posted)
This study consists of a Phase 1b portion aimed to determine the maximum tolerated dose and the safety profile of PF-03084014 in combination with gemcitabine and nab-paclitaxel followed by a Phase 2 portion to evaluate the efficacy of the triple combination in terms of overall survival in patients with metastatic pancreatic ductal adenocarcinoma not previously treated with anticancer therapies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer Pancreas | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| PF-03084014 | Drug | Nirogacestat | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase 1
- description
- PF-03084014 in combination with gemcitabine and nab-paclitaxel
- interventionNames
- Drug: PF-03084014
- Drug: Gemcitabine
- Drug: Nab-paclitaxel
- type
- EXPERIMENTAL
- label
- Phase 2 Arm A
- description
- PF-03084014 in combination with gemcitabine and nab-paclitaxel
- interventionNames
- Drug: PF-03084014
- Drug: Gemcitabine
- Drug: Nab-paclitaxel
- type
- ACTIVE_COMPARATOR
- label
- Phase 2 Arm B
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically diagnosis of metastatic ductal adenocarcinoma of the pancreas. * No prior radiotherapy, surgery chemotherapy or investigational therapy for metastatic disease. Prior adjuvant therapy with 5-FU or gemcitabine (± gemcitabine post radiation) administered as radiosensitizer allowed, provided at least 6 months have elapsed between the last dose and study registration * Tumor tissue available (Archival 6 months old or de novo biopsy) * Measurable disease as per RECIST 1.1 * Performance Status (ECOG) 0 or 1 Exclusion Criteria: * Symptomatic brain metastases requiring steroids * Prior therapy with gamma secretase inhibitors or other Notch pathway inhibitor * Major surgery within 4 weeks of registration in the current study * Known hypersensitivity to gemcitabine or nab-paclitaxel or any of the excipients * Current or anticipated need for food or drugs that are strong/moderate CYP3A4 inhibitors or inducers * Diagnosis of any second malignancy within 3 years prior to registration
References
Publications (0)
Data not yet available