www.OncologyEducation.ca Cabozantinib (XL184) in metastatic castration-resistant prostate cancer (mCRPC): Results from a phase II randomized discontinuation trial. Authors: Hussain M. et al, ASCO 2011 Abstract: 4516 Reviewed by: Dr. Lori Wood Date posted: June 2011
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Www. Cabozantinib (XL184) in metastatic castration- resistant prostate cancer (mCRPC): Results from a phase II randomized discontinuation.
STUDY RATIONALE New agents for metastatic CRPCa are needed Cabozantinib (XL184) –An oral TKI of MET and VEGFR –MET drives tumor cell invasion and metastases –MET and VEGFR synergize to promote angiogenesis In prostate cancer –Pre-clinically – ADT MET expression –MET with progression and metastases
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www.OncologyEducation.ca
Cabozantinib (XL184) in metastatic castration-resistant prostate cancer (mCRPC): Results from a
phase II randomized discontinuation trial.
Authors: Hussain M. et al, ASCO 2011Abstract: 4516Reviewed by: Dr. Lori WoodDate posted: June 2011
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Please acknowledge OncologyEducation.ca and Dr. Lori Wood when using these slides.
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STUDY RATIONALE
• New agents for metastatic CRPCa are needed• Cabozantinib (XL184)
– An oral TKI of MET and VEGFR– MET drives tumor cell invasion and metastases– MET and VEGFR synergize to promote angiogenesis
• In prostate cancer– Pre-clinically – ADT MET expression– MET with progression and metastases
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R
PR/CR
STUDY DESIGN
- Metastatic CRPCa patients: - 0-1 prior chemotherapy - all received Cabozantinib 100 mg p.o. qd x 12 weeks- Primary objectives: - lead-in stage – RECIST RR - randomized stage - PFS- Planned n=200; accrual discontinued after n=171 due to better than expected results
Phase III Randomized Discontinuation Trial
SD
PD
Continue
Continue (n=14)
Placebo (n=17)
Stop
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RESULTS
PR/CR
Open Label Extension
n=79 (46%)
SD
Randomized
n=31 (18%)
Off Study
n=61 (36%)
PD = 16%
AE = 15%
Death = 1%
Other = 4%
At 12 Weeks
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RESULTS
• Lead-in stage– 68% overall objective disease control at week 12– 74% measurable soft tissue disease regression– 76% complete or partial bone scan resolution– 67% improvement in pain– PSA changes did not correlate with radiological