A phase II study to determine if the drug midostaurin taken orally twicedaily is effective and safe in treating patients with Agressive SystemicMastocytosis or Mast Cell Leukemia +/- an associated hematological clonalnon-mast cell lineage disease
- Conditions
- Agressive Systemic Mastocytosis (ASM) or Mast Cell Leukemia (MCL) +/- an Associated Hematological Clonal Non-Mast Cell Lineage Disease (AHNMD)MedDRA version: 17.0Level: LLTClassification code 10056453Term: Aggressive systemic mastocytosisSystem Organ Class: 100000004851Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2008-000280-42-NO
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 116
- Male or female pts aged = 18 years of age
- ECOG performance status of 0-3
- life expectancy > 12 weeks
- ECG QTc interval = 450 ms
- following lab values:
AST and ALT =2.5 x ULN, if caused by ASM/MCL: = 5 x ULN
Serum Bilirubin = 1.5 ULN, if related to ASM/MCL: =3x ULN
Serum Creatinine = 2.0 mg/dl
- diagnosed with ASM or MCL according to WHO criteria for SM plus for ASM or MCL
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
- patients unwilling or unable to comply with the protocol
- any other concurrent severe known disease and/or severe uncontrolled medical
condiction which could compromise participation in the study
- patients with cardiovascular disease including congestive heart failure grade III or IV according to the NYHA classification, left ventricular ejection fraction of <50%, myocardial infection within previous 6 months and poorly controlled hypertension
- confirmed diagnosis of HIV infection or active viral hepatitis
- female patients who are pregnant or breast feeding or adults of reproductive potential not employing a highly effective method of birth control which is defined as a birth control which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly
- patients presenting with an AHNMD requiring immediate cytoreductive therapy or targeted drugs (other than midostaurin)
- patients who have demonstrated relapse to 3 or more prior regimens of SM
treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method