HIGH-RISK MYELODYSPLASTIC SYNDROME (MDS) MedDRA version: 12.0 Level: LLT Classification code 10028533 Term: Myelodysplastic syndrome
Conditions
Interventions
Trade Name: ERLOTINIB / TARCEVA®
Pharmaceutical Form: Capsule*
Sponsors
Groupe Francophone des Myélodysplasies (GFM)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria 1.Diagnosis of MDS according to the WHO classification, but also including RAEB in transformation as defined by the FAB classification (that is patients with up to 30% of blasts in the bone marrow); 2.Higher-risk MDS as defined by a IPSS score >1 (IPSS: Int-2 or High); 3.Life expectancy > 3 months; 4.Percentage of bone marrow blasts >10 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria 1.Serum creatinine = 1.5 x the upper limit of normal, or creatinine clearance =60 mL/min; 2.Concomitant treatment with NSAIDS, warfarin, omeprazole, ranitidine or inducers (i.e. rifampicin, phenytoin; carbamazepin) or inhibitors (i.e. ketoconazole, ciprofloxacin, clarithromycine, voriconazole) of CYP3A4; 3.Inadequate liver function as defined by a serum bilirubine =1.5 x the upper limit of normal (except in the case of confirmed moderate unconjugated hyperbilirubinemia due to intramedullary hemolysis, as observed frequently in MDS), and/or ASAT/ALAT/GGT levels =2 x the upper limit of normal; 4.Known HIV-positivity; 5.Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he or she participates in the study; 6.Vitamine B12 or folate deficiency; 7.Pregnant or lactating females; 8.Use of cytotoxic chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within the 28 days preceeding study entry; 9.Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast), unless the subject has been disease-free for =3 years; 10.Patients with a history of corneal disorders or another active ophthalmic disorder, active infections or other concomitant serious and uncontrolled medical conditions. 11.History of interstitial lung disease or any active pulmonary disease. Patients with a history of myeloproliferative syndrome or LMMC.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The Main objective of the trial 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.;Secondary Objective: The secondary objectives are: •response duration •survival •correlation of prognostic parameters, response and survival, with the assessed biological parameters (NPM, p14 etc, for details see “biological studies”) •treatment-related toxicity ;Primary end point(s): Primary end point: The evaluation of the efficiency will be achieved by evaluating the response rate (CR, PR, mCR and HI) according to the IWG 2000 and 2006 criteria | — |
Countries
France
Outcome results
None listed