High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have Metastatic Pancreatic Cancer

PHASE1/PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

January 1, 2019

Primary Completion Date

January 31, 2022

Study Completion Date

December 31, 2022

Conditions
Metastatic Pancreatic Cancer
Interventions
DRUG

Ascorbic Acid

"Four escalating dose levels are planned in order to determine the MTD for Phase II~The dose level for Phase II patients will be determined following completion of the Phase 1b study based on response from 3-6 patients receiving the designated dose level of ascorbic acid."

DRUG

nab paclitaxel

30 minute IV infusions on days 1 and 8 repeated every 21 days, followed by Cisplatin

DRUG

Cisplatin

60minute IV infusion on days 1 and 8 repeated every 21 days followed by Gemcitabine

DRUG

Gemcitabine

30 minute IV infusion on days 1 and 8 repeated every 21 days

Trial Locations (3)

30214

Piedmont Cancer Institute, Fayetteville

30265

Piedmont Cancer Institute, Newnan

30318

Piedmont Cancer Institute, Atlanta

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Cancer Research UK

OTHER

collaborator

Stand Up To Cancer

OTHER

collaborator

Lustgarten Foundation

OTHER

collaborator

Destroy Pancreatic Cancer

OTHER

collaborator

Translational Genomics Research Institute

OTHER

lead

Piedmont Cancer Institute

OTHER

NCT03797443 - High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have Metastatic Pancreatic Cancer | Biotech Hunter | Biotech Hunter