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A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)

NCT01124786 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 367

Last updated 2014-04-17

Study results available
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Summary

The purpose of this study is to determine whether CO-1.01 is safe and effective in the treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared with gemcitabine.

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Interventions

DRUG

CO-1.01

1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks

DRUG

Gemcitabine

1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks

Sponsors & Collaborators

  • Clovis Oncology, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-11-30
Completion
2013-06-30

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Russia
  • Sweden
  • Ukraine
  • United Kingdom

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 NCT01124786 on ClinicalTrials.gov