A Phase II Study of Oral Once Daily GW572016 (Lapatinib) In Patients With Hormone Refractory Prostate Cancer
OBJECTIVES:
Primary
- Determine the proportion of patients with hormone-refractory prostate cancer who
experience > 50% decline in PSA after treatment with lapatinib ditosylate.
Secondary
- Determine the safety of this drug in these patients.
- Determine the time to PSA progression in patients treated with this drug.
- Determine the molecular correlates and predictive biomarkers of response in patients
treated with this drug.
OUTLINE: This is a multicenter, open-label study.
Patients receive oral lapatinib ditosylate once daily. Treatment continues in the absence of
disease progression or unacceptable toxicity.
Serum samples are collected for biomarker analysis at baseline and every 4 weeks.
After completion of study treatment, patients are followed at 4 weeks.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients with early hormone refractory prostate cancer experiencing decrease in measurable disease after treatment with lapatinib (GW572016).
Radiographic response will be measured using RECIST criteria for patients with measurable disease every 12 weeks. Subjects will be evaluated for CR (complete response), PR (partial response), SD (stable disease) or PD (progressive disease)
Every 12 weeks until disease progression
No
Young Whang, MD, PhD
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
United States: Food and Drug Administration
LCCC 0505
NCT00246753
October 2005
May 2013
Name | Location |
---|---|
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Rex Cancer Center at Rex Hospital | Raleigh, North Carolina 27607 |