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

PHASE1RecruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

April 17, 2022

Primary Completion Date

March 31, 2025

Study Completion Date

March 31, 2026

Conditions
Cancer MetastaticMetastatic Solid Tumor
Interventions
BIOLOGICAL

Zeaxanthin

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_PRODUCT

Zeaxanthin 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."

Trial Locations (1)

07652

RECRUITING

The Valley Hospital-Luckow Pavilion, Paramus

All Listed Sponsors
lead

Valley Health System

OTHER