Recent Updates
Recently added Catalysts

XL281

Phase 1

Cancer | Small molecule | Oncology |Exelixis, Inc.|Last Updated: Oct 13, 2011

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment180
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00451880Study of XL281 in Adults With Solid TumorsPHASE1 COMPLETED 180 — — Feb 1, 2007Oct 1, 2011Oct 13, 20116 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Safety, tolerability, and maximum tolerated dose (MTD) of once daily or twice daily oral administration of XL281
Assessed at periodic visits
To assess the pharmacokinetic/pharmacodynamic/preliminary clinical activity relationship following XL281 administration in different tumor types from subjects treated at the MTD
Assessed at periodic visits
To determine the bioavailability of XL281 under fed and fasted conditions, and with or without the concomitant use of a single dose of famotidine in subjects with solid tumors
Assessed during the second, third, and fourth week of the first cycle of dosing
Secondary Endpoints
Plasma pharmacokinetics of once daily or twice daily oral administration of XL281
Assessed at periodic visits
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTALXL281 administered once a day
Arm 2EXPERIMENTALXL281 administered twice a day
Arm 3EXPERIMENTALXL281 administered once a day. Subjects in this arm will be dosed under fed conditions, fasted conditions, and with a concomitant single dose of 40 mg famotidine, during the second, third, and fourth week of the first cycle.
Interventions
NameTypeDescription
XL281DRUGGelatin capsules supplied as 5-, 25-, and 100-mg strengths
famotidineDRUGsingle dose, supplied as 20-mg or 40-mg tablets
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Key Inclusion Criteria: * The subject has a histologically confirmed solid tumor that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no therapies known to prolong survival. Subjects treated at the MTD (onc...

Countries:United States
Unlock Eligibility Criteria
Competitive Landscape -Cancer 5 trials
CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520 / GEH200521 - Part A
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
Unlock Competitive Intelligence