Clinical trial NCT02950103: Efficacy and Safety of Synthetic Phosphoethanolamine in Solid Tumor Patients
Official title: Efficacy and Safety Evaluation of Synthetic Phosphoethanolamine in Solid Tumor Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Solid Tumor
Keywords: solid tumor
phase II
phosphoethanolamine
Lead sponsor: Secretaria de Estado da Saúde
Sponsor class: OTHER_GOV
Collaborators: name: Instituto do Cancer do Estado de São Paulo
First posted: 2016-10-31
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: RECIST v 1.1 response rate or specific criteria for prostate cancer
timeFrame: 8 weeks
Secondary outcomes:
measure: Treatment related toxicities as determined by CTCAE version 4.0
timeFrame: Every cycle, up to 30 days after drug interruption
measure: Overall survival
timeFrame: Survival followed every 2 months from inclusion until death, withdrawal, loss to follow-up, or study end for up to 60 months
measure: Disease free survival
timeFrame: 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
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo
state: SP
Study officials:
References: