Determine Safety & Recommended Phase 2 Dosing of Zeaxanthin Alone or in Combination w/Pembrolizumab in Patients With Metastatic Cancer
- Conditions
- Cancer MetastaticMetastatic Solid Tumor
- Interventions
- Biological: ZeaxanthinCombination Product: Zeaxanthin Plus Pembrolizumab
- Registration Number
- NCT05232409
- Lead Sponsor
- Valley Health System
- Brief 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.
- Detailed Description
The primary purpose of the study is to determine the safety and optimal dosing of zeaxanthin. Effects on tumor growth will also be looked at but as a secondary endpoint. This study will use a 3+3 design which means that 3 people will receive a certain dose of zeaxanthin and if well tolerated then the next group of people will receive a higher dose. This dose escalation will continue until the highest dose allowed by the study is reached, or a dose is found that is felt not to be safe. If at a given dose one of the three people develops a severe side effect, then three more people will be treated at that dose. If no additional severe side effects develop, then the dose escalation will continue. If two people at a given dose develop severe side effects, that dose will be considered dose limiting and escalation will stop. The doses of zeaxanthin will be based on weight starting with 2 milligrams of zeaxanthin per kilogram of 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 72
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Zeaxanthin Monotherapy Zeaxanthin Zeaxanthin administered orally on daily basis. Zeaxanthin plus Pembrolizumab 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 Measures
Name Time Method Zeaxanthin monotherapy (continued) Toxicities experienced within 28 days of zeoxanthin initiation Rate of Dose Limiting Toxicity (DLT) Based on CTEP Active Version (version 5.0) of the NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0) in patients with unresectable advanced solid tumors treated with zeaxanthin
Zeaxanthin plus Pembrolizumab Up to 20 weeks for each dosing cohort Recommended maximum tolerated dose
Highest dose of zeoxanthin that does not cause dose limiting toxicity in patients with unresectable advanced solid tumors treated with zeaxanthin plus pembrolizumabZeaxanthin monotherapy Up to 20 weeks for each dosing cohort Recommended maximum tolerated dose
Highest dose of zeaxanthin that does not cause dose limiting toxicity in patients with unresectable advanced solid tumors treated with zeaxanthinZeaxanthin plus Pembrolizumab (continued) Toxicities experienced within 42 days of zeaxanthin plus pembrolizumab initiation Rate of Dose Limiting Toxicity (DLT)
Based on CTEP Active Version (version 5.0) of the NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0) in patients with unresectable advanced solid tumors treated with zeaxanthin plus pembrolizumab
- Secondary Outcome Measures
Name Time Method The disease control rate (DCR) in patients with unresectable advanced solid tumors treated with zeaxanthin Week 8 and Week 24 Percentage of patients with complete response, partial response, or stable disease according to RECIST v1.1 measured at 2 months and 6 months after initiation of zeaxanthin treatment
The progression free survival (PFS) for zeaxanthin plus pembrolizumab in in patients with unresectable advanced solid tumors Up to 24 months The PFS rate for zeaxanthin in patients with unresectable advanced solid tumors as measured by RECIST v1.1
The maximal plasma concentration of zeaxanthin in patients treated with zeoxanthin Pharmacokinetic (PK) sampling will be performed on Day 1, 2, 8, 15,22, 28, 56, 84 To evaluate the effect of multiple doses of zeaxanthin on the steady state pharmacokinetics of zeoxanthin in patients with unresectable advanced solid tumors treated with zeaxanthin
The duration of response (DR) in patients with unresectable advanced solid tumors treated with zeaxanthin 36 months The DR by RECIST v1.1 of zeaxanthin in patients with unresectable advanced solid tumors
Area under the curve (AUC) of zeaxanthin in patients with unresectable advanced solid tumors treated with zeaxanthin Pharmacokinetic (PK) sampling will be performed on Day 1, 2, 8, 15,22, 28, 56, 84 Pharmacokinetics of zeaxanthin as measured by AUC
The response rate (ORR) of zeaxanthin in patients with unresectable advanced solid tumors 36 months The ORR by RECIST v1.1 of zeaxanthin in patients with unresectable advanced solid tumors Duration of response: duration from date of initial attainment of CR or PR to date of progression, censoring at death or lost to follow-up Disease Control rate: percent of patients who develop CR, PR, or stable disease as best response as determined by RECIST v1.1 measured at 2 months and 6 months after initiation of study treatment Progression Free Survival: duration of time in months from the initiation of study treatment to date of progression, censoring at death or lost to follow-up.
The response rate of zeaxanthin plus pembrolizumab in patients with unresectable advanced solid tumors 36 months The ORR by RECIST v1.1 of zeaxanthin plus pembrolizumab in patients with unresectable advanced solid tumors
The duration of response in patients with unresectable advanced solid tumors treated with zeaxanthin plus pembrolizumab 36 months The DR by RECIST v1.1 of zeaxanthin plus pembrolizumab in patients with unresectable advanced solid tumors
The disease control rate (DCR) in patients with unresectable advanced solid tumors treated with zeaxanthin plus zeaxanthin Week 8 and Week 24 Percentage of patients with complete response, partial response, or stable disease according to RECIST v1.1 measured at 2 months and 6 months after initiation of zeaxanthin plus pembrolizumab treatment
The progression free survival (PFS) for zeaxanthin in in patients with unresectable advanced solid tumors Up to 24 months The PFS rate for zeaxanthin in patients with unresectable advanced solid tumors as measured by RECIST v1.1
The maximal plasma concentration of zeoxanthin in patients treated with zeoxanthin plus pembrolizumab Pharmacokinetic (PK) sampling will be performed on Day 1, 2, 8, 15,22, 43, 64 To evaluate the effect of multiple doses of zeoxanthin on the steady state pharmacokinetics of zeoxanthin in patients with unresectable advanced solid tumors treated with zeaxanthin plus pembrolizumab
Area under the curve (AUC) of zeaxanthin in patients with unresectable advanced solid tumors treated with zeaxanthin plus pembrolizumab Pharmacokinetic (PK) sampling will be performed on Day 1, 2, 8, 15,22, 28, 56, 84 Pharmacokinetics of zeaxanthin as measured by AUC
Trial Locations
- Locations (1)
The Valley Hospital-Luckow Pavilion
🇺🇸Paramus, New Jersey, United States