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Safety and Efficacy of Clopidogrel in Locally Advanced and Metastatic Pancreatic Adenocarcinoma Treated With Chemotherapy

NCT02404363 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2019-07-25

No results posted yet for this study

Summary

Clopidogrel has been shown to slow down tumor progression in orthoptic pancreatic murine tumor.

In a pilot study, the rate of microparticles was correlated with response rate of pancreatic adenocarcinoma.

The aim of the study is;

* to compare the phenotypes of coagulation, the tumor progression and metastasis formation with and without clopidogrel treatment in association with chemotherapy in advanced pancreatic cancer patients
* to correlate the decrease of microparticles levels after one month of chemotherapy with tumor response (ancillary study)

Conditions

Interventions

DRUG

Clopidogrel

Clopidogrel tablets 75 mg for six months: In case of treatment with aspirin \< or = 75 mg/d or prophylactic LMWH --\> clopidogrel 75 mg/d If aspirin = 0 + LMWH = 0 --\> clopidogrel 150 mg/d x 7days then 75mg/d

DRUG

Placebo

Placebo tablets 75 mg for six months: In case of treatment with aspirin \< or = 75 mg/d or prophylactic LMWH --\> placebo 75 mg/d If aspirin = 0 + LMWH = 0 --\> placebo 150 mg/d x 7days then 75mg/d

Sponsors & Collaborators

  • Groupe Francophone Thrombose et Cancer

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Philippe DEBOURDEAU, MD · Institut Sainte Catherine - Avignon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-11
Primary Completion
2017-12-04
Completion
2018-03-27

Countries

  • France

Study Locations

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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 NCT02404363 on ClinicalTrials.gov