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NCT04394858
Testing the Addition of an Anticancer Drug, Olaparib, to the Usual Chemotherapy (Temozolomide) for Advanced Neuroendocrine Cancer
Phase 2 trial testing Biospecimen Collection in Advanced Adrenal Gland Pheochromocytoma in 46 participants. Participants enrolled and being followed up; not accepting new ones.
1 March 2028
Quick facts
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 17 March 2021 |
| Primary completion | 1 March 2028 |
| Estimated completion | 1 March 2028 |
| Sites | 163 locations across United States |
Drugs / interventions tested
- Biospecimen Collection — full drug profile →
- Computed Tomography with Contrast
- Magnetic Resonance Imaging
- Olaparib (olaparib) — full drug profile →
- Quality-of-Life Assessment
- Temozolomide (temozolomide) — full drug profile →
Conditions studied
- Advanced Adrenal Gland Pheochromocytoma — all drugs for Advanced Adrenal Gland Pheochromocytoma →
- Advanced Paraganglioma — all drugs for Advanced Paraganglioma →
- Metastatic Adrenal Gland Pheochromocytoma — all drugs for Metastatic Adrenal Gland Pheochromocytoma →
- Metastatic Paraganglioma — all drugs for Metastatic Paraganglioma →
Sponsor
National Cancer Institute (NCI)
Who can join
12 and older, any sex, with Advanced Adrenal Gland Pheochromocytoma or Advanced Paraganglioma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04394858
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04394858 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
- Last refreshed: 13 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04394858.
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