Recent Updates
Recently added Catalysts

XL820

Phase 2

Gastrointestinal Stromal Tumors | Small molecule | Oncology |Exelixis, Inc.|Last Updated: Jun 7, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00570635A Phase 2 Study of XL820 in Adults With Advanced GIST Resistant to Imatinib and/or SunitinibPHASE2 COMPLETED 16 — — Dec 1, 2007May 1, 2009Jun 7, 20133 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Clinical benefit, defined as either confirmed complete response, confirmed partial response, or evidence of stable disease lasting ≥16 weeks, in subjects with advanced GIST resistant to/intolerant of imatinib and/or sunitinib
Assessed at baseline, Week 4 and 8, and every 8 weeks thereafter
Secondary Endpoints
Safety and tolerability of XL820
Assessed at each visit
Progression-free survival, duration of response, and overall survival
Assessed until progression
Further characterize the pharmacokinetic and pharmacodynamic parameters of XL820 in subjects with advanced GIST
Assessed during periodic visits
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTAL -
BEXPERIMENTAL -
Interventions
NameTypeDescription
XL820DRUGXL820 capsules administered orally as a single agent at a dose of 800 mg daily
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Patients with metastatic or locally advanced or unresectable GIST who have intolerance of or disease progression following prior treatment with imatinib and/or sunitinib * ECOG (Eastern Cooperative Oncology Group) performance status ≤2 * Must have measurable disease per RECIST...

Countries:United States
Unlock Eligibility Criteria