Pancreas Adenocarcinoma Clinical Trial
Official title:
A Phase I Dose-Escalation Study of CPI-613 (Devimistat) in Combination With Chemoradiation in Patients With Pancreatic Adenocarcinoma
This is a single-center, open-label, phase I study designed to determine the maximum tolerated dose (MTD) and safety profile of CPI-613® when used concomitantly with chemoradiation for local control of pancreatic adenocarcinoma (PDAC).
This study is designed to test the hypothesis that a combination of gemcitabine and radiation therapy (Gem-RT) with CPI-613®, a selective mitochondrial metabolism inhibitor in PDAC tumor cells, will be well tolerated without additional significant toxicity. Additionally, CPI-613® is expected to improve the Gem-RT effectiveness, resulting in durable local control of disease. As a necessary and initial step to translate preclinical observations into a patient setting and test our proposed hypotheses, the investigators will perform a dose-finding phase I clinical trial that has been designed to evaluate the maximum tolerated dose (MTD), recommended phase II dose (RP2D), and safety profile of CPI-613® along with standard of care Gem-RT in patients with unresectable PDAC in need of definitive local control of disease. The overarching goals for this trial are to determine the safety and toxicity of CPI-613® when given concurrently with Gem-RT. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06065891 -
Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer
|
N/A | |
| Recruiting |
NCT05351983 -
Patient-derived Organoids Drug Screen in Pancreatic Cancer
|
N/A | |
| Completed |
NCT01774162 -
EUS-guided Fine Needle Biopsy With a New Core Histology Needle Versus Conventional Fine Needle Aspiration
|
N/A | |
| Recruiting |
NCT04164602 -
The Occurence of Pancreatic Cancer Studied in Association With Newly Diagnosed Diabetes in the Elderly
|
||
| Completed |
NCT05161013 -
A Proof-of-Concept Study Evaluating LINFU™
|
N/A | |
| Recruiting |
NCT05470920 -
Genetic Testing Decision Aid
|
N/A | |
| Recruiting |
NCT04099134 -
PACAREG: a Multicenter Registry Trial in Pancreatic Ductal Adencarcinoma
|
||
| Completed |
NCT05518071 -
FLUOPANC-trial - Fluorescence-guided Surgery of Pancreatic and Bileduct Tumors Using cRGD-ZW800-1
|
Phase 2 | |
| Withdrawn |
NCT04045730 -
The Study of Gemcitabine Plus Nab-Paclitaxel in Combination With Pegvorhyaluronidase Alfa (PVHA; PEGPH20) and Pembrolizumab as Front-line Treatment for Metastatic Pancreatic Adenocarcinoma.
|
Phase 2 | |
| Recruiting |
NCT06160596 -
Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis
|
||
| Recruiting |
NCT04636788 -
Circulating Extracellular Exosomal Small RNA as Potential Biomarker for Human Pancreatic Cancer
|
N/A | |
| Recruiting |
NCT04435067 -
Evaluation of Clinical, Radiomics and Molecular Features of Lung Metastasis in PDAC Patients (LUMACA Trial)
|
||
| Recruiting |
NCT04571294 -
Para-aortic Lymphnodes Removal During Upfront Pancreaticoduodenectomy
|
N/A | |
| Recruiting |
NCT06451497 -
Phase 1 Trial of ZM008 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT03472716 -
The βIG-H3 Protein: a New Marker in PANCreatic Adenocarcinoma (BIGHPANC)
|
||
| Completed |
NCT03532347 -
Endoscopic Ultrasound Guided Tissue Sampling (The SharkBITE Study)
|
N/A | |
| Withdrawn |
NCT06090318 -
Milademetan in Combination With Atezolizumab in Patients With Advanced Solid Tumors With CDKN2A Loss
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06381882 -
The Role of the Human Microbiome in Patients After Pancreatic Resection.
|
||
| Recruiting |
NCT03544255 -
Drug Screening of Pancreatic Cancer Organoids Developed From EUS-FNA Guided Biopsy Tissues
|
||
| Recruiting |
NCT05340569 -
Diagnostic Value of DWI-MRI for Detection of Peritoneal Metastases in High-risk Pancreatic Ductal Adenocarcinoma.
|
N/A |