Trial | NCT02950103  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    ethanolamine ...

  • Study Participants

    73
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.
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.
Study Started
Aug 31
2016
Primary Completion
Mar 31
2017
Study Completion
Sep 30
2019
Last Update
Sep 30
2019

Drug Phosphoethanolamine

Phosphoethanolamine PO daily

Synthetic phosphoethalonamine Experimental

Phosphoethanolamine PO daily

Criteria 

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
No Results Posted