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NCT06176989 · ClinicalTrials.gov registry record · Phase 2
Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors
A Phase 2 study of Metastatic Large-cell Neuroendocrine Carcinoma and Metastatic Chondrosarcoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06176989 is a Phase 2 study of Metastatic Large-cell Neuroendocrine Carcinoma and Metastatic Chondrosarcoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 40 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06176989, a Phase 2 study of Metastatic Large-cell Neuroendocrine Carcinoma and Metastatic Chondrosarcoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Cancers of the nasal cavity or skull base are rare. They often are not diagnosed until they are at an advanced stage, and they often spread to other parts of the body. These cancers may have mutations in a gene called IDH2. Researchers want to find out if a drug (enasidenib) that targets the IDH2 mutation can help people with these cancers. Objective: To test enasidenib in people with cancers of the nasal cavity or skull base. Eligibility: People aged 18 years and older with rare cancers of the nasal cavity or the base of the skull. Their cancer must have an IDH2 gene mutation, and it must have recurred locally or spread to other parts of the body. These cancers can include sinonasal undifferentiated carcinoma; olfactory neuroblastoma; sinonasal large-cell neuroendocrine carcinoma; poorly differentiated sinonasal adenocarcinoma; or chondrosarcoma. Design: Participants will be screened. They will have a physical exam with blood and urine tests and tests of their heart function. They will have imaging scans of their brain, skull base, neck, chest, abdomen, and pelvis. A sample of tumor tissue will be collected. Enasidenib is a tablet taken by mouth with a glass of water. Participants will take the drug once a day, every day, in 28-day cycles. They will not have resting periods between cycles. Participants will visit the clinic on the first day of each cycle to receive the tablets they will need to take at home until the beginning of the next cycle. They will keep a diary to record the time of each dose they take. Participants may remain in the study as long as the drug is helping them....
Conditions Studied
Interventions
- DRUG Enasidenib
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-03-04 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06176989
The ClinicalTrials.gov registry entry for NCT06176989 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Metastatic Large-cell Neuroendocrine Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which Enasidenib is the first listed.
NCT06176989 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06176989 about?
NCT06176989 is a clinical study titled "Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors". Background: Cancers of the nasal cavity or skull base are rare. They often are not diagnosed until they are at an advanced stage, and they often spread to other parts of the body. These cancers may have mutations in a gene called IDH2. Researchers want to find out if a drug (enasidenib) that target...
What is the current status of trial NCT06176989?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2024-03-04. Estimated completion is 2030-12-31.
What conditions does trial NCT06176989 study?
This clinical trial studies the following conditions: Metastatic Large-cell Neuroendocrine Carcinoma, Metastatic Chondrosarcoma, Locally Advanced Chondrosarcoma, Metastatic Sinonasal Adenocarcinoma, Locally Advanced Sinonasal Adenocarcinoma.
What interventions are being tested in trial NCT06176989?
The interventions under investigation include: Enasidenib (DRUG).
Who is sponsoring clinical trial NCT06176989?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06176989 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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