NCT02504333

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

A Phase I/II Study of Nab-paclitaxel (Abraxane) and Gemcitabine Followed by Modified FOLFOX (AG-mFOLFOX) in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of nab-paclitaxel (Abraxane) and gemcitabine followed by modified FOLFOX (AG-mFOLFOX) in patients with previously untreated, metastatic pancreatic adenocarcinoma

Conditions

• Metastatic Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-07-01
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2015-07-21
• Last updated: 2023-10-03

Locations

1 site across 1 country: Spain