A Phase II study to determine if the drug midostaurin taken orally twice daily is effective and safe in treating patients with Agressive Systemic Mastocytosis or Mast Cell Leukemia +/- and associated hematological clonal non-mast cell lineage disease

Phase 1

• Conditions: Aggressive Systemic Mastocytosis or Mast Cell Leukemia +/- an Associated Hematological Clonal Non-Mast Cell Lineage Disease; MedDRA version: 19.1 Level: LLT Classification code 10056453 Term: Aggressive systemic mastocytosis System Organ Class: 100000004851; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-000280-42-GB
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-18
• Study Completion: 2017-08-24
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 116

Inclusion Criteria

- Male or female patients aged 18 and over
- ECOG performance status of 0-3
- life expectancy > 12 weeks
- ECG QTcF interval = 450 ms
-meeting 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

Exclusion Criteria

- 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
- 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