At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 81 enrolled

Drug / intervention

Cilengitide 500 mg +1 moredrug

Likely dose

Cilengitide 500 mg or 2000 mg IV once daily, twice weekly (Days 1 and 4 of each 4-week cycle)AI-extracted

Key inclusion· 6

✓Histologically proven GBM recurrent or progressive after surgery/biopsy, radiation, and 1 prior systemic chemotherapy regimen
✓Measurable disease (solid contrast-enhancing lesion ≥1 cm) on gadolinium-enhanced MRI within 2 weeks of first dose
✓At least 12 weeks since last radiation and at least 4 weeks since last chemotherapy (6 weeks for nitrosourea)
✓If recent surgery, ≥2 weeks post-surgery or ≥1 week post-biopsy, stable on stable corticosteroid regimen ≥5 days

Key exclusion· 8

✕Prior radiation therapy >66 Gray
✕Prior antiangiogenic therapy
✕Placement of Gliadel wafer at surgery for recurrence
✕History of prior malignancy (except curatively treated cervical CIS, basal cell carcinoma, or malignancy-free ≥5 years)

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

Search/NCT00093964

NCT00093964Phase 2Completed

Compare CT.gov

A Multicenter, Open-label, Randomized, Uncontrolled, Phase IIa Trial in Subjects With Recurrent Glioblastoma Multiforme to Investigate the Clinical Activity, Safety, and Tolerability of Cilengitide (EMD 121,974) Administered as a Single Agent.

EMD Serono·interventional·Posted Oct 11, 2004·Updated Apr 16, 2019

In Brief

A Phase 2 clinical trial evaluating Cilengitide 500 mg and Cilengitide 2000 mg for Glioblastoma Multiforme. Completed, enrolled 81 participants across 17 sites.

Detailed Summary

This study will investigate clinical activity, safety, and tolerability of the anti-angiogenic compound cilengitide (EMD 121974) in the treatment of first recurrence of glioblastoma multiforme (GBM).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsGlioblastoma Multiforme

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedOct 2004

Enrollment StartOct 2004

Primary CompletionOct 2005

Study CompletionOct 2010

TodayJul 2026

First PostedOct 11, 2004

Enrollment StartOct 13, 2004

Primary CompletionOct 28, 2005

Study CompletionOct 21, 2010

TodayJul 2, 2026

Enrollment to primary: 1.0 yearsPosted 21.7 years ago

Interventions

Cilengitide 500 mgdrug

Subjects will receive 1-hour intravenous infusion of 500 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.

Cilengitide 2000 mgdrug

Subjects will receive 1-hour intravenous infusion of 2000 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.