CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 49 enrolled
Drug / intervention
lapatinib ditosylate +1 moredrug
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Histologically confirmed prostate cancer
  • ✓Prior definitive surgery or radiation therapy for primary treatment
  • ✓Hormone-sensitive disease with testosterone >150 ng/dL within 4 weeks of enrollment
  • ✓Biochemical progression: baseline PSA followed by 2 rising PSA values ≥6 weeks apart, all within 6 months, all from same reference lab
Key exclusion· 9
  • ✕Evidence of metastatic disease on physical exam, CT/MRI, or bone scan
  • ✕Testosterone-modulating agents (LH-RH agonists/antagonists, antiandrogens) within 1 year prior to enrollment
  • ✕5-alpha reductase inhibitors, ketoconazole, megestrol acetate, systemic steroids, or herbal supplements at any time during PSA collection
  • ✕Prior vaccine or immunotherapy for prostate cancer

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00103194
NCT00103194Phase 2Completed
CompareCT.gov

Phase II Trial of GW572016 in Patients With Recurrent Prostate Cancer as Evident by a Rising PSA

National Cancer Institute (NCI)·interventional·Posted Feb 8, 2005·Updated Sep 30, 2014

In Brief

A Phase 2 clinical trial evaluating lapatinib ditosylate and laboratory biomarker analysis for Recurrent Prostate Cancer and 4 related conditions. Completed, enrolled 49 participants across 1 site.

Detailed Summary

This phase II trial studies how well lapatinib ditosylate works in treating patients with a rising prostate-specific antigen (PSA), a protein made by the prostate gland, indicating that prostate cancer has come back after previous treatment. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may delay or prevent the progression of prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 8, 2005
Enrollment StartSep 1, 2005
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 21.4 years ago

Interventions

lapatinib ditosylatedrug

Given PO

laboratory biomarker analysisother

Correlative studies