RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-04-17
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05232409

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Kathleen Sayles
CONTACT
201-634-5792
ksayles@valleyhealth.com
Robyn Puso
CONTACT
201-634-5792
rpuso@valleyhealth.com

Principal Investigator

Philip Friedlander, MD
PRINCIPAL_INVESTIGATOR
The Valley Hospital

Study Locations (Sites)

The Valley Hospital-Luckow Pavilion
Paramus, New Jersey, 07652
United States

Collaborators and Investigators

Sponsor: Valley Health System

  • Philip Friedlander, MD, PRINCIPAL_INVESTIGATOR, The Valley Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-17
Study Completion Date2026-03

Study Record Updates

Study Start Date2022-04-17
Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

  • Cancer Metastatic
  • Metastatic Solid Tumor