TRIAL DETAIL

LBH589 Plus Imatinib

Drug:
Trial Name:
LBH589 Plus Imatinib
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Ongoing, but not recruiting
Phase:
1
Start Date 07/09/2010
Age of Trial (yrs) 11.4
Treatment Phase:
Gleevec-resistant
Drug Category:
HDAC inhibitor + KIT/PDGFRA inhibitor
Strategy:
Block KIT + Unblock cell death genes + Destroy KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
Sponsor:
Patient Contact:
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
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

Trial Links

 
 
 
 

Trial Results

Drug Information

See panobinostat drug link
 

Trial Sites

Name
Address
City
State
Zip
Country
Hufelandstr. 55
Essen
45122
Germany
Pieskower Straße 33
Bad Saarow
15526
Germany