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Testing the Addition of an Anticancer Drug, Olaparib, to the Usual Chemotherapy (Temozolomide) for Advanced Neuroendocrine Cancer

NCT04394858 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-05-13

No results posted yet for this 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.

Conditions

  • Advanced Adrenal Gland Pheochromocytoma
  • Advanced Paraganglioma
  • Metastatic Adrenal Gland Pheochromocytoma
  • Metastatic Paraganglioma
  • Stage III Adrenal Gland Pheochromocytoma and Sympathetic Paraganglioma AJCC v8
  • Stage IV Adrenal Gland Pheochromocytoma and Sympathetic Paraganglioma AJCC v8
  • Unresectable Adrenal Gland Pheochromocytoma
  • Unresectable Paraganglioma

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Computed Tomography with Contrast

Undergo CT with contrast

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Olaparib

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

DRUG

Temozolomide

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Jaydira Del Rivero · Alliance for Clinical Trials in Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-17
Primary Completion
2028-03-01
Completion
2028-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04394858 on ClinicalTrials.gov