Efficacy and Safety of Synthetic Phosphoethanolamine in Solid Tumor Patients

NCT02950103 | Terminated Phase 2 DMC

• 1 other identifier: NP977
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Keywords

solid tumor; phase II; phosphoethanolamine

Outcome Measures

Primary Outcomes (1)

• RECIST v 1.1 response rate or specific criteria for prostate cancer

  8 weeks

Secondary Outcomes (3)

• 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

Study Arms (1)

Synthetic phosphoethalonamine

EXPERIMENTAL

Phosphoethanolamine PO daily

Drug: Phosphoethanolamine

Interventions

Phosphoethanolamine DRUG

Phosphoethanolamine PO daily

Synthetic phosphoethalonamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Secretaria de Estado da Saúde: lead
• Instituto do Cancer do Estado de São Paulo: collaborator

Study Sites (1)

Instituto do Cancer do Estado de Sao Paulo

São Paulo, São Paulo, 01246-000, Brazil

Location

MeSH Terms

Interventions

phosphorylethanolamine

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: October 31, 2016
• Study Start: August 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: September 1, 2019
• Last Updated: September 30, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)