PHASE I-II TRIAL OF ERLOTINIB IN HIGHER RISK MYELODYSPLASTIC SYNDROME - GFM-Erlotinib-08

• Conditions: HIGH-RISK MYELODYSPLASTIC SYNDROME (MDS); MedDRA version: 12.0Level: LLTClassification code 10028533Term: Myelodysplastic syndrome

• Registration Number: EUCTR2008-005999-28-FR
• Lead Sponsor: Groupe Francophone des Myélodysplasies (GFM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-28
• Last Update Posted: 19 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 <30%;
5.Ineligible for or having failed intensive chemotherapy and ineligible for or having failed previous therapy with a hypomethylating agent;
6.Age = 18 years;
7.Written informed consent;
8.Patient must understand and voluntarily sign consent form;
9.Patient must be able to adhere to the visit schedule as outlined in the study and follow protocol requirements;
10.ECOG performance status between 0-2 at the time of screening;
11.Females of childbearing potential (defined as a sexually mature woman who has not undergone a hysterectomy or who is not naturally postmenopausal for at least 24 consecutive months, that is who has had menses at any time during the preceeding 24 consecutive months) have to have a negative pregnancy test;
12.Adequate contraceptive methods should be carried out by all patients during therapy and for at least 2 weeks after completing therapy.
13.No existing contra-indication to treatment with erlotinib.
14.Health insurance.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified