Efficacy and Safety of Synthetic Phosphoethanolamine in Solid Tumor Patients

Efficacy and Safety Evaluation of Synthetic Phosphoethanolamine in Solid Tumor Patients

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.

Study Overview

• Status: Terminated
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: Phosphoethanolamine

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.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 01246-000
      • Instituto do Cancer do Estado de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Synthetic phosphoethalonamine; Phosphoethanolamine PO daily	Drug: Phosphoethanolamine; Phosphoethanolamine PO daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
RECIST v 1.1 response rate or specific criteria for prostate cancer	8 weeks

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Secretaria de Estado da Saúde
• Collaborators: Instituto do Cancer do Estado de São Paulo

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: September 26, 2016
• First Submitted That Met QC Criteria: October 28, 2016
• First Posted (Estimate): October 31, 2016

Study Record Updates

• Last Update Posted (Actual): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: solid tumor; phase II; phosphoethanolamine
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: NP977

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No