Perioperative Fostamatinib With Gemcitabine and Nab-paclitaxel in Resectable Pancreatic Cancer
NCT06639724 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2026-04-07
Summary
This is a Phase 1b trial evaluating the combination of Fostamatinib, a Syk kinase inhibitor currently FDA-approved for chronic idiopathic thrombocytopenia purpura (ITP), with the standard of care chemotherapy agents gemcitabine and nab-paclitaxel, for the perioperative treatment of resectable non metastatic pancreatic ductal adenocarcinoma (PDAC).
Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
Interventions
- COMBINATION_PRODUCT
-
Fostamatinib in combination with chemotherapy (gemcitabine and nab-paclitaxel)
Fostamatinib is a Syk kinase inhibitor currently FDA-approved for chronic idiopathic thrombocytopenia purpura but it has not been studied in PDAC. The investigators hypothesize that Syk inhibition reprograms macrophages to an immunostimulatory phenotype in the tumor microenvironment. Thus, Syk inhibition with fostamatinib in combination with chemotherapy could improve outcomes for patients with PDAC while having a favorable safety profile.
Sponsors & Collaborators
-
Rigel Pharmaceuticals
collaborator INDUSTRY -
University of California, San Diego
lead OTHER
Principal Investigators
-
Andrew Lowy, MD · UCSD
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-05
- Primary Completion
- 2027-12-31
- Completion
- 2028-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Antigen-specific Cancer Immunotherapy (TG01) and Gemcitabine as Adjuvant Therapy in Resected Pancreatic Cancer
NCT02261714 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer
NCT02243007 ·Status: TERMINATED ·Phase: PHASE2
-
Proglumide With Gemcitabine and Nab-Paclitaxel in PatientsWith Metastatic Pancreatic Ductal Adenocarcinoma
NCT06017323 ·Status: WITHDRAWN ·Phase: PHASE1
-
Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma
NCT06069778 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Phase II Randomized Study of Gemcitabine and Nab-paclitaxel in Combination With S- 1/LV (GASL) or Oxaliplatin (GAP) as First-line Treatment for Metastatic Pancreatic Cancer
NCT05026905 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients
NCT06119217 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic Cancer
NCT02210559 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
High or Standard Intensity Radiation Therapy After Gemcitabine Hydrochloride and Nab-paclitaxel in Treating Patients With Pancreatic Cancer That Cannot Be Removed by Surgery
NCT01921751 ·Status: TERMINATED ·Phase: PHASE2
-
Testing the Combination of Two Approved Chemotherapy Drugs and Radiation Prior to Surgery in Localized Pancreatic Cancer
NCT03492671 ·Status: RECRUITING ·Phase: PHASE2
-
The Effect of Gemcitabine Plus Nab-paclitaxel as Secondary Chemotherapy in Advanced Pancreatic Cancer
NCT03401827 ·Status: UNKNOWN ·Phase: PHASE4
-
Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread
NCT04233866 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Gemcitabine Hydrochloride, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Metformin Hydrochloride, and a Standardized Dietary Supplement in Treating Patients With Pancreatic Cancer That Cannot be Removed by Surgery
NCT02336087 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
An Open-Label Study of Ruxolitinib Given With Chemotherapy in Patients With Advanced Solid Tumors
NCT01822756 ·Status: TERMINATED ·Phase: PHASE1
-
Efficacy and Safety of Modified Nab-Paclitaxel Plus Gemcitabine Chemotherapy for Metastatic Pancreatic Cancer
NCT03502343 ·Status: UNKNOWN ·Phase: PHASE2
-
Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic Nabpaclitaxel-Gemcitabine Chemotherapy for Pancreatic Cancer Peritoneal Metastases
NCT05371223 ·Status: RECRUITING ·Phase: PHASE2
-
Sintilimab Combined With Chemotherapy and Radiotherapy in Patients With Inoperable Pancreatic Cancer
NCT06050317 ·Status: RECRUITING ·Phase: PHASE2
-
Second-Line Adjuvant Therapy With Nab-Paclitaxel Plus Gemcitabine Versus Oxaliplatin Plus Folinic Acid and Fluorouracil for Gemcitabine-Refractory Pancreatic Cancer After Curative Resection
NCT02506842 ·Status: UNKNOWN ·Phase: PHASE3
-
PTK787 in Patients With Advanced Metastatic Pancreatic Adenocarcinoma
NCT00226005 ·Status: COMPLETED ·Phase: PHASE2
-
Study Of Gemcitabine, Nab-paclitaxel, PEGPH20 and Rivaroxaban for Advanced Pancreatic Adenocarcinoma
NCT02921022 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Ibrutinib Combined With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer
NCT02562898 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Determine Function of Antroquinonol in Combination With SOC in First Line Metastatic Pancreatic Cancer
NCT03310632 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Phase II Study Evaluating BMS-986504 in MTAP-deleted Pancreatic Cancer
NCT07283705 ·Status: RECRUITING ·Phase: PHASE2
-
Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced, Unresectable Pancreatic Cancer
NCT03941093 ·Status: COMPLETED ·Phase: PHASE3
-
Neoadjuvant Folfirinox Combined With Pembrolizumab Followed by Surgery for Patients With Resectable Pancreatic Cancer
NCT05132504 ·Status: RECRUITING ·Phase: PHASE2
-
Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer
NCT00068432 ·Status: COMPLETED ·Phase: PHASE2