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NCT04394858 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of an Anticancer Drug, Olaparib, to the Usual Chemotherapy (Temozolomide) for Advanced Neuroendocrine Cancer
A Phase 2 study of Metastatic Adrenal Gland Pheochromocytoma and Metastatic Paraganglioma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 20
- Study locations
NCT04394858: Active Phase 2 study of Metastatic Adrenal Gland Pheochromocytoma and Metastatic Paraganglioma, sponsored by National Cancer Institute (NCI).
NCT04394858 is a Phase 2 study of Metastatic Adrenal Gland Pheochromocytoma and Metastatic Paraganglioma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04394858, a Phase 2 study of Metastatic Adrenal Gland Pheochromocytoma and Metastatic Paraganglioma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well the addition of olaparib to the usual treatment, temozolomide, works in treating patients with neuroendocrine cancer (pheochromocytoma or paraganglioma) that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Poly (adenosine diphosphate \[ADP\]-ribose) polymerases (PARPs) are proteins that help repair deoxyribonucleic acid (DNA) mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving olaparib with temozolomide may shrink or stabilize the cancer in patients with pheochromocytoma or paraganglioma better than temozolomide alone.
Primary Outcome
Will be compared between treatment arms using the un-stratified log-rank test at one-sided level of 0.11 and the p-value will be used for decision making. The hazard ratio will be estimated using a Cox proportional hazards model and the 95% confidence interval for the hazard ratio will be provided. Results from a stratified analysis will also be provided. Kaplan-Meier methodology will be used to estimate the median PFS for each treatment arm, and Kaplan-Meier curves will be produced. Brookmeyer-
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Quality-of-Life Assessment
- PROCEDURE Magnetic Resonance Imaging
- DRUG Olaparib
- PROCEDURE Computed Tomography with Contrast
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
Idaho
- Saint Luke's Cancer Institute - Boise - Boise
- Saint Luke's Cancer Institute - Fruitland - Fruitland
- Saint Luke's Cancer Institute - Meridian - Meridian
- Saint Luke's Cancer Institute - Nampa - Nampa
- Saint Luke's Cancer Institute - Twin Falls - Twin Falls
Illinois
- Illinois CancerCare-Bloomington - Bloomington
- Illinois CancerCare-Canton - Canton
- Illinois CancerCare-Carthage - Carthage
- Centralia Oncology Clinic - Centralia
Florida
- Holy Cross Hospital - Fort Lauderdale
- UF Health Cancer Institute - Gainesville - Gainesville
California
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2021-03-17 |
| Est. Completion | 2028-03-01 |
| Phase | Phase 2 |
What the registry record for NCT04394858 still lists
NCT04394858 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 8 conditions, with Metastatic Adrenal Gland Pheochromocytoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04394858 names 20 study sites across 5 states, led by Alaska, Idaho, Illinois.
Frequently Asked Questions
What is clinical trial NCT04394858 about?
NCT04394858 is a clinical study titled "Testing the Addition of an Anticancer Drug, Olaparib, to the Usual Chemotherapy (Temozolomide) for Advanced Neuroendocrine Cancer". This phase II trial studies how well the addition of olaparib to the usual treatment, temozolomide, works in treating patients with neuroendocrine cancer (pheochromocytoma or paraganglioma) that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot ...
What is the current status of trial NCT04394858?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2021-03-17. Estimated completion is 2028-03-01.
What conditions does trial NCT04394858 study?
This clinical trial studies the following conditions: Metastatic Adrenal Gland Pheochromocytoma, Metastatic Paraganglioma, Advanced Adrenal Gland Pheochromocytoma, Advanced Paraganglioma, Stage III Adrenal Gland Pheochromocytoma and Sympathetic Paraganglioma AJCC v8.
What interventions are being tested in trial NCT04394858?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Quality-of-Life Assessment (OTHER), Magnetic Resonance Imaging (PROCEDURE), Olaparib (DRUG), Computed Tomography with Contrast (PROCEDURE).
Who is sponsoring clinical trial NCT04394858?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04394858 being conducted?
This trial has 20 study locations across Alaska, California, Florida, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04394858's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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