TRIAL DETAIL

Phase II Trial of Vandetanib in Children and Adults With Wild-Type Gastrointestinal Stromal Tumors

Drug:
Trial Name:
Phase II Trial of Vandetanib in Children and Adults With Wild-Type Gastrointestinal Stromal Tumors
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Ongoing, but not recruiting
Phase:
2
Start Date 09/01/2013
Age of Trial (yrs) 10.6
Treatment Phase:
Gleevec-resistant
Drug Category:
EGFR and VEGF inhibitor
Strategy:
Block related tumor signal paths
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
130208, 13-C-0208
Sponsor:
National Cancer Institute (NCI)
Patient Contact:
Claudia P Derse-Anthony (301) 402-0199 derseanthonycp@mail.nih.gov CFernanda I Arnaldez, M.D (301) 451-7014 arnaldezf@mail.nih.gov
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
Age:

-greater than or equal to 3 years of age and BSA greater than or equal to 0.5 m(2)

Diagnosis

Histologically or cytologically confirmed GIST by the Laboratory of Pathology, NCI.
Absence of Kit and PDGFRA mutation confirmed in a CLIA certified laboratory.
Participants must have measurable disease as defined in RECIST (v1.1) as the presence of at least one lesion not previously irradiated, that can be accurately measured at baseline greter than or equal to 10mm in the longest diameter (except lymph nodes which must have short axis greater than or equal to 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements.

Trial Links

 

Trial Results

 
 

Drug Information

Caprelsa.com
 
NIH video that discusses a possible trial of vandetanib for pediatric-type GIST.
 
A phase II trial of Vandetanib (ZD6474, Caprelas) in Children and Adults with Succinate Dehydrogenase Deficient GIST
 

Trial Sites

Name
Address
City
State
Zip
Country
9000 Rockville Pike
Bethesda
MD
20892
USA