Solid Tumor
Conditions
Keywords
solid tumor, phase II, phosphoethanolamine
Brief summary
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
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.
Interventions
DRUGPhosphoethanolamine
Phosphoethanolamine PO daily
Sponsors
Instituto do Cancer do Estado de São Paulo
Secretaria de Estado da Saúde
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RECIST v 1.1 response rate or specific criteria for prostate cancer | 8 weeks |
Secondary
| Measure | 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 |
Countries
Brazil
Outcome results
None listed