CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 200 enrolled
Drug / intervention
hCRF +1 moredrug
Likely dose
hCRF 2 mg/day subcutaneously twice daily for 12 weeksAI-extracted
Key inclusion· 6
  • ✓Histologically confirmed primary malignant brain tumor or metastatic disease with documented histology of primary source
  • ✓At least one steroid-associated side effect at baseline
  • ✓Dexamethasone use for ≥30 days to control peritumoral edema symptoms
  • ✓Stable dexamethasone dose of 4-24 mg/day for ≥14 days prior to baseline
Key exclusion· 11
  • ✕Planned surgery, radiosurgery, radiation therapy, or new chemotherapy within first 5 weeks of enrollment
  • ✕Concurrent enrollment in another investigational drug or device trial or planned enrollment within first 5 weeks
  • ✕Systemic steroid use for indications other than peritumoral brain edema
  • ✕Use or intended use of dexamethasone as an anti-emetic during screening or study

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

Search/NCT00088166
NCT00088166Phase 3Completed
CompareCT.gov

A Phase III Randomized, Double-Blind, Dexamethasone-Sparing Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Placebo for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Malignant Brain Tumor Who Require Chronic Administration of High-Dose Dexamethasone

Celtic Pharma Development Services·interventional·Posted Jul 22, 2004·Updated Aug 13, 2014

In Brief

A Phase 3 clinical trial evaluating hCRF and placebo hCRF for Brain Edema and Brain Tumor. Completed, enrolled 200 participants across 34 sites in 2 countries.

Detailed Summary

The purpose of this study is to compare the safety and efficacy of XERECEPT® to dexamethasone (Decadron) a common treatment for symptoms of brain swelling (edema). This study is specifically aimed at patients who require chronic high doses of dexamethasone to manage symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Edema, Brain Tumor
CountriesCanada, United States
CollaboratorsNeurobiological Technologies

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 22, 2004
Enrollment StartMay 1, 2004
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 21.9 years ago

Interventions

hCRFdrug

hCRF ; open-label dexamethasone that the patient is currently taking

placebo hCRFdrug

placebo hCRF 2mg/day and open-label dexamethasone that they are taking