Efficacy and Safety of Synthetic Phosphoethanolamine in Solid Tumor Patients

Study Overview
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Brief Summary
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Synthetic phosphoethanolamine is a primary amine which has a critical role in the biosynthesis of cell membranes. Pre-clinical models have shown potential anticancer activity.

Detailed Description
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Phase II multi-cohort study based on two-stage Simon design. The primary goal of the study is response rate at 8 weeks in participants with advanced solid tumors treated with synthetic phosphoethanolamine, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) or specific criteria for prostate cancer.

Official Title
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Efficacy and Safety Evaluation of Synthetic Phosphoethanolamine in Solid Tumor Patients

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: Phosphoethanolamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven advanced solid tumor patients (recurrent or metastatic), not amenable to curative therapy. Patients must have progressed to standard treatment proven to prolong survival or no standard treatment exists. Tumor types include head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal adenocarcinoma, breast cancer, cervix cancer, prostate cancer, melanoma, pancreas adenocarcinoma, gastric adenocarcinoma, hepatocellular carcinoma No concurrent active systemic treatment Measurable disease by RECIST v1.1 Clinical or radiological progression in the last three months Eastern Cooperative Oncology Group Performance Status 0-1 Ability to consent Adequate organ function Life expectancy greater than 12 weeks Ability to swallow No previous malignancy in the last 5 years Exclusion Criteria: Pregnancy Corticosteroid therapy for prostate cancer Uncontrolled comorbidity Known hepatitis B, C and HIV Central nervous system involvement, except if controlled symptoms and without corticosteroids Previous use of phosphoethalonamine

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synthetic phosphoethalonamine<br>Phosphoethanolamine PO daily | Drug: Phosphoethanolamine<br>* Phosphoethanolamine PO daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RECIST v 1.1 response rate or specific criteria for prostate cancer |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment related toxicities as determined by CTCAE version 4.0 |  | Every cycle, up to 30 days after drug interruption | 
| Overall survival |  | Survival followed every 2 months from inclusion until death, withdrawal, loss to follow-up, or study end for up to 60 months | 
| Disease free survival |  | Tumor assessment by RECIST v1.1 or prostate cancer specific criteria every 8 weeks for up to 12 months, then every 12 weeks until loss of clinical benefit, withdrawal, death, or study end for up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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solid tumor, phase II, phosphoethanolamine