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XL820

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

XL820 · 3 trials · 3 indications

Phase 2 1Phase 1 2
NCT00570635A Phase 2 Study of XL820 in Adults With Advanced GIST Resistant to Imatinib and/or SunitinibGastrointestinal Stromal Tumors
COMPLETED16 Analytics
PHASE2COMPLETED
A Phase 2 Study of XL820 in Adults With Advanced GIST Resistant to Imatinib and/or Sunitinib
Gastrointestinal Stromal TumorsUnlock trial analytics

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
maximum tolerated dose
safety and tolerability

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
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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
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about XL820

What is XL820 used for?

XL820 is an investigational small molecule being studied for the treatment of cancer, including gastrointestinal stromal tumors (GIST). It has been evaluated in clinical trials for adults with solid tumors and for advanced GIST resistant to imatinib and/or sunitinib.

Who makes XL820?

XL820 is being developed by Exelixis, Inc., a biopharmaceutical company traded on NASDAQ under the ticker EXEL. The company has sponsored clinical trials of XL820 in the United States.

What phase is XL820 in?

XL820 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug that has not been approved by the FDA, and it is no longer in active clinical development based on the completed trial statuses.

What clinical trials is XL820 in?

XL820 has been studied in three completed clinical trials: NCT00129571 and NCT00350831, both Phase 1 studies in adults with solid tumors, and NCT00570635, a Phase 2 study in adults with advanced GIST resistant to imatinib and/or sunitinib. All trials were conducted in the United States.

Is XL820 the same as any other drug?

XL820 is the investigational name used by Exelixis for this compound. No alternative names have been reported in the clinical trial records, and it is distinct from other Exelixis drugs.