Study Details

Open

Phase 2/3 Multicenter, Randomized Open-Label Study of Zanzalintinib vs Everolimus

An important goal of this study is to evaluate the length of time cancer is not growing or spreading in participants when treated with zanzalintinib compared to everolimus. In addition, this study will also evaluate if zanzalintinib can shrink tumors and help participants live longer as compared to everolimus. This information will help researchers learn if zanzalintinib can be used to treat neuroendocrine cancer.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

If you are eligible to participate in this study, you will undergo one or more of the study procedures at each study visit. Some of these procedures may no longer be necessary depending on the visit day in the study treatment cycle. Your study doctor will let you know if you are not required to undergo a procedure. Please note that you may be asked to repeat a procedure or test and/or have additional procedures if your study doctor feels it is needed to evaluate your condition. You will need to visit the study site regularly (for about 3 to 4 hours per visit) so that your study doctor can check how you are responding to study treatment. Some procedures may also be a part of your normal care. 30 days after stopping the study drug, you will also attend an End of Study Safety Follow-Up. This visit will check your general health and well-being after stopping the study drug. You should not eat or drink 8 hours before this visit.

In-person visits:
12

Total length of participation:
60 months

Looking for Specific Volunteers

Able to participate:

Age 18 years or older on the day of consent.
ECOG performance status of 0-1.
Adequate organ and marrow function, based upon specific assessments
Platelets ≥ 100,000/mm³ (≥ 100 x 10⁹/L) without transfusion within 2 weeks before screening laboratory sample collection.
Hemoglobin ≥ 9 g/dL (≥ 90 g/L) without transfusion within 2 weeks before screening laboratory sample collection.

Not eligible if:

Histologically confirmed neuroendocrine carcinomas (including small cell lung cancer), medullary thyroid cancer, pheochromocytoma, paraganglioma, Merkel cell carcinoma, and mixed neuroendocrine non-neuroendocrine neoplasm (MiNEN).
Systemic chemotherapy and any liver-directed or other ablative therapy within 4 weeks before randomization.
Radiation therapy for bone metastases within 2 weeks, any other radiation therapy, except as indicated above, within 4 weeks before randomization.
Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks before randomization.
Previously identified allergy or hypersensitivity to active pharmaceutical ingredient or any component of either study treatment formulations.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Secondary Visit Location

Gastrointestinal (GI) Medicine
UNC Hospitals Hillsborough Campus
460 Waterstone Dr, Hillsborough, NC 27278, USA

Additional Study Information

Principal Investigator

Jonathan Sorah
Medicine- Oncology

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Liver, Pancreatic)
Kidneys and Liver

IRB Number

25-1455

ClinicalTrials.gov

NCT06943755