Efficacy and Safety of Synthetic Phosphoethanolamine in S... | NCT02950103

Studies
Efficacy and Safety of Synthetic Phosphoethanolamine in Solid Tumor Patients

NCT02950103

Sponsor

Secretaria de Estado da Saúde

Status

Terminated

Last Update Posted

Sep 30, 2019Actual

Enrollment

73Actual

Phase

Phase 2

Conditions

Solid Tumor

Interventions

Phosphoethanolamine

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Mar 2017Actual

Completion Date

Sep 2019Actual

First Submitted Date

Sep 26, 2016

First Submission Date that Met QC Criteria

Oct 28, 2016

First Posted Date

Oct 31, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2019

Last Update Posted Date

Sep 30, 2019Actual

Name	Class
Instituto do Cancer do Estado de São Paulo	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

73Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Synthetic phosphoethalonamine	Experimental	Phosphoethanolamine PO daily	Drug: Phosphoethanolamine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phosphoethanolamine	Drug	Phosphoethanolamine PO daily	Synthetic phosphoethalonamine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Instituto do Cancer do Estado de Sao Paulo		São Paulo	São Paulo	01246-000	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided