Solid TumorPhase 2NCT02950103
Efficacy and Safety of Synthetic Phosphoethanolamine in Solid Tumor Patients
A Phase 2 study testing Phosphoethanolamine in people with Solid Tumor, run by Secretaria de Estado da Saúde at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Phosphoethanolamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2016to Sep 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Adequate organ function
- Life expectancy greater than 12 weeks
- Ability to swallow
- No previous malignancy in the last 5 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Cancer do Estado de Sao Paulo
São Paulo, São Paulo, 01246-000
About this study
Official title: 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.
Read the 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.
- Conditions
- Solid Tumor
- Being tested
- Phosphoethanolamine
- Keywords
- solid tumor, phase II, phosphoethanolamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhosphoethanolamineDrug
Phosphoethanolamine PO daily
| Study group | Role | What they receive |
|---|---|---|
| Synthetic phosphoethalonamine | Experimental | Phosphoethanolamine PO daily Receives: Drug: Phosphoethanolamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
RECIST v 1.1 response rate or specific criteria for prostate cancer
Measured: 8 weeks
Secondary outcomes (3)
Treatment related toxicities as determined by CTCAE version 4.0
Measured: Every cycle, up to 30 days after drug interruption
Overall survival
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2017
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Secretaria de Estado da Saúde
- Sponsor type
- Other government
- Collaborators
- Instituto do Cancer do Estado de São Paulo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950103
- Sponsor's protocol ID
- NP977
- Status last verified
- Sep 2019
- First submitted
- 26 Sep 2016
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Synthetic Phosphoethanolamine in Solid Tumor Patients
- ClinicalTrials.gov ID
- NCT02950103
- Acronym / sponsor ID
- NP977
- Conditions
- Solid Tumor
- Keywords
- solid tumor, phase II, phosphoethanolamine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Secretaria de Estado da SaúdeOther government
- Collaborators
- Instituto do Cancer do Estado de São Paulo
- Study start
- Aug 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Synthetic phosphoethalonamine | Experimental | Drug: PhosphoethanolaminePhosphoethanolamine PO daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhosphoethanolaminePhosphoethanolamine PO daily | Drug | Synthetic phosphoethalonamine |
Primary outcome
RECIST v 1.1 response rate or specific criteria for prostate cancer
Time frame: 8 weeks
3 secondary outcomes
Treatment related toxicities as determined by CTCAE version 4.0
Time frame: Every cycle, up to 30 days after drug interruption
Overall survival
Time frame: 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
Time frame: 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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Phosphoethanolamine in people with Solid Tumor, run by Secretaria de Estado da Saúde at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RECIST v 1.1 response rate or specific criteria for prostate cancer (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.