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Efficacy of ABI-007 Plus Gemcitabine or sLV5FU2 as First-line Therapy in Patients With Metastatic Pancreatic Cancer

NCT01964534 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2017-01-31

No results posted yet for this study

Summary

To evaluate the combination of ABI-007 with gemcitabine or with LV5FU2.

Conditions

Interventions

DRUG

ABI-007

ABI-007 : 125 mg/m² IV /30min (day 1, day 8, day 15)

DRUG

Gemcitabine

1000 mg/m² IV /30min (day 1, day 8, day 15)

DRUG

simplified LV5FU2

Folinic acid: 400 mg/m² IV /2h (day 1, day 15) Bolus 5-FU: 400 mg/m² IV /15min (day 1, day 15) 5-FU infusion: 2400 mg/m² IV /46h (day 1-2, day 15-16)

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • GERCOR - Multidisciplinary Oncology Cooperative Group

    lead OTHER

Principal Investigators

  • Jean-Baptiste Bachet, MD · Hôpital La Pitié-Salpêtrière

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-12
Primary Completion
2017-02-28
Completion
2017-07-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01964534 on ClinicalTrials.gov