LBH589 Plus Imatinib

LBH589 Plus Imatinib

Gastrointestinal Stromal Tumor

Ongoing, but not recruiting

1

Start Date 07/09/2010

Age of Trial (yrs) 14.9

Gleevec-resistant

HDAC inhibitor + KIT/PDGFRA inhibitor

Block KIT + Unblock cell death genes + Destroy KIT

Specifically GIST and only GIST

Oral

Inclusion Criteria:

Male or female patients > 18 years of age
evidence of progressive despite 800mg Imatinib and 3 months Sunitinib (50mg qd / 37.5 4w/2w) or intolerance (at that dose)
ECOG PS of 0, 1 or 2
Adequate bone marrow, liver and renal function, Serum transaminase activity (AST/SGOT & ALT/SGPT) < 2.5 X ULN, Serum total bilirubin < 1.5 x ULN, Serum creatinine < 1.5 x ULN ,or a creatinine clearance of ≥ 60 mL/min.
Fasting serum cholesterol  350 mg/dL, Triglycerides  300 mg/dL
Proteinuria  1g in 24 h
No prior thromboembolic disease
No history of hematemesis or hemoptysis
Patients may have received other direct KIT-inhibitors such as Dasatinib, Nilotinib or Sorafenib