CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
rhuMAb 2C4 (pertuzumab)drug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Histologically confirmed adenocarcinoma of the prostate, refractory or resistant to hormone therapy with documented progression after ≥4 weeks washout (≥6 weeks for nilutamide/bicalutamide)
  • ✓Prior taxane-based chemotherapy with documented disease progression (PSA ≥5 ng/mL with rising trend, measurable disease by RECIST, or new bone lesions)
  • ✓Castrate testosterone level maintained by orchiectomy or LHRH agonist (<70 ng/mL)
  • ✓Age ≥18 years with life expectancy ≥12 weeks
Key exclusion· 8
  • ✕Prior HER2 pathway inhibitors (trastuzumab, gefitinib, erlotinib, C225, CI1033, TAK165)
  • ✕Prior or clinical evidence of CNS or brain metastases
  • ✕Cardiac ejection fraction <50% on echocardiography
  • ✕Uncontrolled hypercalcemia (>11.5 mg/dL)

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

Search/NCT00058539
NCT00058539Phase 2Completed
CompareCT.gov

A Phase II, Open-Label, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Omnitarg (Pertuzumab) in Subjects With Castration-Resistant Prostate Cancer

Genentech, Inc.·interventional·Posted Apr 9, 2003·Updated Jun 23, 2015

In Brief

A Phase 2 clinical trial evaluating rhuMAb 2C4 (pertuzumab) for Prostate Cancer. Completed, enrolled 42 participants.

Detailed Summary

The purpose of this study is to evaluate safety and efficacy of Omnitarg (Pertuzumab) on cancerous lesions in men with castration-resistant (hormone-refractory) prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 9, 2003
Enrollment StartApr 1, 2003
Primary CompletionOct 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 23.2 years ago

Interventions

rhuMAb 2C4 (pertuzumab)drug