Efficacy and Safety of Synthetic Phosphoethanolamine in Solid Tumor Patients

Secretaria de Estado da Saúde

Status and phase

Terminated

Phase 2

Conditions

Solid Tumor

Treatments

Drug: Phosphoethanolamine

Study type

Interventional

Funder types

Other

Identifiers

NCT02950103

NP977

Details and patient eligibility

About

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.

Full description

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.

Enrollment

73 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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