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

NCT02504333 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2023-10-03

No results posted yet for this study

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

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

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Alfredo Carrato, MD PhD · Hospital Universitario Ramón y Cajal

  • Carmen Guillén, MD · Hospital Universitario Ramón y Cajal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02504333 on ClinicalTrials.gov