NCT00246753

Lapatinib in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

A Phase II Study of Oral Once Daily GW572016 (Lapatinib) In Patients With Hormone Refractory Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well lapatinib works in treating patients with prostate cancer that did not respond to hormone therapy.

Detailed description

OBJECTIVES: Primary * Determine the proportion of patients with hormone-refractory prostate cancer who experience \> 50% decline in prostate-specific antigen (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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	lapatinib ditosylate	1500 mg, daily until disease progression

Timeline

• Start date: 2005-10-01
• Primary completion: 2012-07-01
• Completion: 2013-05-01
• First posted: 2005-10-31
• Last updated: 2017-06-28
• Results posted: 2017-06-28

Locations

3 sites across 1 country: United States