CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
cilengitidedrug
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Histologically or cytologically confirmed prostate cancer
  • ✓No evidence of metastatic disease or local progression
  • ✓PSA progression (≥3 consecutive rising levels >1 week apart; final value ≥2 ng/mL within 2 weeks of registration) despite androgen deprivation therapy with ≥28 days washout from flutamide or ≥42 days from bicalutamide/nilutamide
  • ✓Continue LHRH agonist; may continue stable doses of megestrol or corticosteroids; off all other cancer-treatment therapies for ≥4 weeks
Key exclusion· 6
  • ✕Prior EMD 121974 (cilengitide) therapy not allowed
  • ✕No investigational or commercial agents for cancer treatment allowed during study
  • ✕Herbal, alternative, and food supplements (e.g., PC-Spes, Saw Palmetto, St John Wort) must be discontinued; daily multivitamin allowed
  • ✕Cannot initiate bisphosphonate therapy immediately prior to or during study; may continue if stable dose started ≥6 weeks prior and showing PSA progression

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

Search/NCT00121238
NCT00121238Phase 2Completed
CompareCT.gov

Phase II Evaluation of EMD 121974 (NSC 707544, Cilengitide) in Patients With Non-Metastatic Androgen Independent Prostate Cancer

National Cancer Institute (NCI)·interventional·Posted Jul 21, 2005·Updated Apr 28, 2016

In Brief

A Phase 2 clinical trial evaluating cilengitide for Recurrent Prostate Cancer and 4 related conditions. Completed, enrolled 16 participants across 1 site.

Detailed Summary

This phase II trial is studying how well cilengitide works in treating patients with prostate cancer. Cilengitide may stop the growth of prostate cancer by blocking blood flow to the tumor

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 PostedJul 21, 2005
Enrollment StartJan 1, 2005
Primary CompletionNov 1, 2010
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 20.9 years ago

Interventions

cilengitidedrug

Given IV