Erlotinib in Higher Risk Myelodysplastic Syndrome

Sponsor
Groupe Francophone des Myelodysplasies
Study ID
NCT01085838
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Myelodysplastic Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Mar 12, 2010
Start date
Jul 31, 2010
Status verified
Mar 2013
Primary completion
Mar 31, 2014
Completion
Mar 31, 2014

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    The first cohort of 5 patients will start with a dosage of 100 mg erlotinib daily
  • Experimental: Cohort 2
    The second cohort of patients will receive 150 mg of erlotinib daily
  • Experimental: Cohort 3
    The third cohort of five patients will be enrolled to receive 300 mg of erlotinib daily

Primary Outcome Measure

The primary objective is to estimate the overall response rate (CR, PR, mCR The primary objective is to estimate the overall response rate (CR, PR, mCR and HI according to the IWG 2000 and 2006 criteria) in patients treated with erlotinib. [ Time Frame: After 12 weeks treatment ]

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