At a glance
ClinicalIndex Comparison Record- ✓Completed participation in study NTI 0302, NTI 0303, or other designated studies
- ✓Karnofsky Performance Status >50 at baseline
- ✓Able to self-administer subcutaneous injections twice daily or have caregiver assistance
- ✓Able to provide written informed consent or have legal guardian/representative provide it
- ✕Concurrent enrollment in other investigational drug or device studies (except NTI 0302, NTI 0303, or designated studies)
- ✕Systemic steroid use for any indication other than peritumoral brain edema
- ✕Use or intended use of dexamethasone as an anti-emetic during study
- ✕Clinical signs and symptoms of cerebral herniation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Labeled, Extended-Use of Human Corticotropin-Releasing Factor (hCRF) Intended for Patients Who Participate in Dexamethasone-Sparing Studies NTI 0302, NTI 0303, or Other Designated Studies
In Brief
A Phase 3 clinical trial evaluating hCRF [XERECEPT (corticorelin acetate injection)] for Brain Edema and Brain Tumor. Completed, enrolled 112 participants across 32 sites in 2 countries.
Detailed Summary
The purpose of this study is to examine the long-term safety and tolerability of human corticotropin-releasing factor (hCRF), XERECEPT®, in patients requiring dexamethasone (Decadron) to treat peritumoral brain edema. This open-label, extended-use study is open to all patients who participate in either of the blinded studies, NTI 0302, NTI 0303, or other designated studies, including patients who may have discontinued blinded study medication early but completed the protocol-stipulated follow-up periods.
Study Details
Timeline
Interventions
2mg/day