Phase I/II Study of Nab-paclitaxel and Gemcitabine Followed by AG-mFOLFOX in Patients With Metastatic Pancreatic Adenocarcinoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

April 30, 2021

Study Completion Date

April 30, 2021

Conditions
Metastatic Pancreatic Adenocarcinoma
Interventions
DRUG

nab-paclitaxel

Day 1-8-15: Intravenous, 125 mg/m2 over 30 minutes

DRUG

gemcitabine

Day 1-8-15: Intravenous, 1.000 mg/m2 over 30 minutes

DRUG

m-FOLFOX

Day 28 according to the dose levels stablished in Phase I

DRUG

nab-paclitaxel

Day 1-8-15: Intravenous 30 minutes according to the dose levels stablished in Phase I

DRUG

gemcitabine

Day 1-8-15: Intravenous 30 minutes according to the dose levels stablished in Phase I

Trial Locations (1)

28046

Spanish Cooperative for Digestive Tumour Therapy (TTD), Madrid

All Listed Sponsors
lead

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

OTHER

NCT02504333 - Phase I/II Study of Nab-paclitaxel and Gemcitabine Followed by AG-mFOLFOX in Patients With Metastatic Pancreatic Adenocarcinoma | Biotech Hunter | Biotech Hunter