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

Part of paid clinical trials in Paramus, New Jersey.

Sponsor
Valley Health System
Study ID
NCT05232409
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Cancer Metastatic
  • Metastatic Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Zeaxanthin — BIOLOGICAL
    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.
  • Zeaxanthin Plus Pembrolizumab — COMBINATION_PRODUCT
    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.

Study Details

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.

Key Dates

Start date
Apr 17, 2022
Status verified
Jun 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
72 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Zeaxanthin Monotherapy
    Zeaxanthin administered orally on daily basis.
  • Experimental: Zeaxanthin plus Pembrolizumab
    Zeaxanthin administered orally on daily basis in addition to intravenous pembrolizumab infused every 42 days at fixed dose of 400 mg.

Primary Outcome Measure

Zeaxanthin monotherapy [ Time Frame: Up to 20 weeks for each dosing cohort ]

Central Contacts

Locations (1)

FacilityCityStateZIP
The Valley Hospital-Luckow PavilionParamusNew Jersey07652

Find similar trials in Paramus, NJ

By research site
The Valley Hospital-Luckow Pavilion· Paramus, NJ

Related Studies