At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 29 enrolled
Drug / intervention
lapatinib ditosylatedrug
Likely dose
Lapatinib ditosylate 1500 mg orally once dailyAI-extracted
Key inclusion· 7
- ✓Histologically confirmed adenocarcinoma of the prostate
- ✓Currently on androgen deprivation therapy (bilateral orchiectomy or medical castration with testosterone <50 ng/dl)
- ✓Biochemical progression on androgen deprivation therapy with PSA ≥5 ng/ml, defined as two successive PSA rises at least one week apart
- ✓ECOG performance status 0-2
Key exclusion· 8
- ✕Prior or concurrent exposure to cytotoxic chemotherapy
- ✕Prior chemotherapy for prostate cancer
- ✕Prior treatment with ErbB family targeting therapies
- ✕Known brain metastases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Oral Once Daily GW572016 (Lapatinib) In Patients With Hormone Refractory Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating lapatinib ditosylate for Prostate Cancer. Completed, enrolled 29 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsGlaxoSmithKline
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2005
First PostedOct 2005
Primary CompletionJul 2012
Study CompletionMay 2013
TodayJul 2026
First PostedOct 31, 2005
Enrollment StartOct 1, 2005
Primary CompletionJul 1, 2012
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 20.7 years ago
Interventions
lapatinib ditosylatedrug
1500 mg, daily until disease progression