RecruitingPhase 1NCT05232409

Determine Safety & Recommended Phase 2 Dosing of Zeaxanthin Alone or in Combination w/Pembrolizumab in Patients With Metastatic Cancer

A Phase I Study to Determine the Safety and Recommended Phase 2 Dosing of Zeaxanthin Alone or in Combination With Pembrolizumab in Patients With Metastatic Solid Tumors


Sponsor

Valley Health System

Enrollment

72 participants

Start Date

Apr 17, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the research is to determine the highest dose of an oral compound called zeaxanthin that can be safely taken each day in patients with advanced cancer, the toxicity profile of zeaxanthin, and the dose of zeaxanthin to use in future cancer clinical trials.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Zeaxanthin and Zeaxanthin Plus Pembrolizumab for people with cancer, metastatic and metastatic solid tumor. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 99 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALZeaxanthin

The doses of zeaxanthin will be based on weight starting with 2 milligrams of zeaxanthin per kilogram of your body weight (mg/kg) followed by 4 mg/kg, 6 mg/kg, and finally 8 mg/kg. If a dose level is found to be unsafe, then a new group of patients will be treated at the midpoint dose between the not tolerated dose and the last tolerated dose. Zeaxanthin is supplied as 50 milligram capsules and a person's dose will be rounded to the nearest 50 milligrams.

COMBINATION_PRODUCTZeaxanthin Plus Pembrolizumab

The doses of zeaxanthin will be based on weight starting with 2 milligrams of zeaxanthin per kilogram of your body weight (mg/kg) followed by 4 mg/kg, 6 mg/kg, and finally 8 mg/kg. If a dose level is found to be unsafe, then a new group of patients will be treated at the midpoint dose between the not tolerated dose and the last tolerated dose. Zeaxanthin is supplied as 50 milligram capsules and a person's dose will be rounded to the nearest 50 milligrams. The dose of pembrolizumab will be administered at a fixed dose of 400 milligrams intravenous every 6 weeks which is an FDA approved dosing schedule to treat cancer patients with pembrolizumab.


Locations(1)

The Valley Hospital-Luckow Pavilion

Paramus, New Jersey, United States

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NCT05232409


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