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Erlotinib in Higher Risk Myelodysplastic Syndrome

NCT01085838 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-11-08

No results posted yet for this study

Summary

The aim of this study is to evaluate the toxicity and therapeutic efficacy of erlotinib in high-risk myelodysplastic syndrome (MDS) patients (with at least 10% of bone marrow blasts) ineligible for or having failed intensive chemotherapy and ineligible or after failure of treatment with a hypomethylating agent.

Conditions

Interventions

DRUG

Erlotinib

Erlotinib oral capsule, 100, 150, or 300 mg/day during 12 weeks at study start

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Groupe Francophone des Myelodysplasies

    lead OTHER

Principal Investigators

  • Sylvain Thepot, MD · GFM/Hôpital Angers

  • Lionel Ades, MD · GFM/Hôpital Saint Louis

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • France

Study Locations

More Related Trials

Entities

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 NCT01085838 on ClinicalTrials.gov