Efficacy and Safety of Synthetic Phosphoethanolamine in Solid Tumor Patients

Solid Tumor Clinical Trial

Official title:

Efficacy and Safety Evaluation of Synthetic Phosphoethanolamine in Solid Tumor Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02950103
• Other study ID #: NP977
• Status: Terminated
• Phase: Phase 2
• Start date: August 2016
• Est. completion date: September 2019

Study information

• Verified date: September 2019
• Source: Secretaria de Estado da Saúde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 73
• Est. completion date: September 2019
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• Phosphoethanolamine
Phosphoethanolamine PO daily

Locations

Country	Name	City	State
Brazil	Instituto do Cancer do Estado de Sao Paulo	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Secretaria de Estado da Saúde	Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RECIST v 1.1 response rate or specific criteria for prostate cancer		8 weeks
Secondary	Treatment related toxicities as determined by CTCAE version 4.0		Every cycle, up to 30 days after drug interruption
Secondary	Overall survival		Survival followed every 2 months from inclusion until death, withdrawal, loss to follow-up, or study end for up to 60 months
Secondary	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