Clinical trial · Interventional
Efficacy and Safety of Synthetic Phosphoethanolamine in Solid Tumor Patients
Efficacy and Safety Evaluation of Synthetic Phosphoethanolamine in Solid Tumor Patients
NCT02950103CI-TRIAL-00040900terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Phosphoethanolamine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Synthetic phosphoethalonamine
- description
- Phosphoethanolamine PO daily
- interventionNames
- Drug: Phosphoethanolamine
Primary outcomes (1)
- measure
- RECIST v 1.1 response rate or specific criteria for prostate cancer
- timeFrame
- 8 weeks
Secondary outcomes (3)
- measure
- Treatment related toxicities as determined by CTCAE version 4.0
- timeFrame
- Every cycle, up to 30 days after drug interruption
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.