ToxicityPhase 1NCT03663881
Safety Assessment of P2Et Extract in Healthy Voluntary Subjects in Colombia
A Phase 1 study testing P2Et extract in people with Toxicity and Safety Issues, run by Hospital Universitario San Ignacio at 1 site in Colombia.
Trial summary
Caesalpinia spinosa extract is rich in gallotannins and other well characterized polyphenols and has a major antioxidant activity. The extract shows immunomodulatory activity in healthy animals and anti-tumor activity in animals with breast cancer and melanoma as well. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Toxicity, Safety Issues
- What is being tested?
- P2Et extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteColombia
- Study dates
- 30 Apr 2019to 15 May 2020
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Adequate renal, hematological, hepatic function defined as:
- Normal renal function defined as serum creatinine ≤ 1.5 mg/dl or creatinine clearance
- 60 mL/min/1.73 m2 (according to local evaluation method).
- Hepatic function: alkaline phosphatase ≤ 2.5 × LSN, aspartate aminotransferase (AST) ≤ 2.5 × LSN, alanine aminotransferase ≤ 2.5 × LSN, total bilirubin ≤ 1.5 × LSN.
- Leukocyte count ≥3,000/mcL, neutrophils absolute count ≥ 1500/mm3 (1.5 × 109/L).
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- Platelets ≥100,000/mm3 (100 × 109/L) and Hemoglobin ≥ 9.0 g/dL in peripheral blood.
- Cardiovascular function: No evidence of acute ischemic heart disease in the electrocardiogram.
- No uncontrolled or significant comorbidities determined by clinical history, physical examination and screening laboratory tests at the discretion of the investigator.
- Women of childbearing age must have a negative pregnancy test (urine or serum) at the time of screening and enrollment.
- Female subjects of childbearing age (those who have not been menopausal at least for 12 months or who have undergone surgical sterilization by bilateral tubal ligation procedure, bilateral oophorectomy or hysterectomy), and their male partners, must use at least one of the below mentioned contraceptive methods at the time of entering the study, throughout the study, and at least 6 months following the P3Et use (the effects of
- P2Et in the developing human fetus are unknown):
- Total abstinence of sexual intercourse, starting at least one complete menstrual cycle prior to the administration of the study drug; (it should be noted that: sexual abstinence as a contraceptive method must be limited to those cases in which it has been established as the pre-existent election of lifestyle by the patient);
- Vasectomized partner of a female subject.
- Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to the administration of the study drug;
- Intrauterine device (IUD)
- Double barrier method (condom, contraceptive sponge, diaphragm or vaginal ring with spermicidal gel or foam).
- Willingness to complete the study interventions and follow-up.
- The subject must sign and date the informed consent form voluntarily for his (her) participation in the study, approved by an Institutional Ethics Committee (IEC) prior to the initiation of any selection procedure or specific to the study.
Who cannot join
- Subjects with one or more of the following conditions are not eligible for this study.
- Subjects receiving any investigational agent and /or taking part in a clinical study in the 30 days prior to the admission or during their participation in the study.
- History of allergic reactions attributed to polyphenol-type compounds similar to those found in green tea.
- Use of dietary supplements or phytopharmaceutical drugs < 15 days prior to the admission and during the study.
- Subjects with diagnosis of an active disease and/or receiving pharmacological treatment prescribed for an active disease and who have evidence of an active disease at the time of the initial clinical examination at the discretion of the investigator.
- Severe, active concomitant morbidity, including but not limited to:
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- Bacterial or fungal acute infection requiring intravenous antibiotics at the time of inclusion.
- Moderate or severe liver failure (B or higher Child-Pugh category with qualification 7 or higher).
- Congestive heart failure grade II or higher according to New York Heart Association requiring hospitalization within 12 months prior to registration.
- Unstable angina and/or congestive heart disease within the previous 6 months
- Severe cardiac arrhythmia with no appropriate control.
- Antecedents of brain hemorrhage or stroke (ACV) or transient ischemic attack within the previous 6 months.
- Myocardial infarction within the previous 6 months.
- Exacerbation of chronic obstructive pulmonary disease or another respiratory disease requiring hospitalization or that precludes the study treatment at the time of inclusion.
- Subjects with a disease indicative of clinically defined Acquired Immunodeficiency Syndrome (AIDS). This is necessary in order to assure that those subjects can be more likely to be suitable to receive the full treatment.
- Any other major clinical disease or psychiatric disorder that, at the discretion of the investigator, precludes the administration or completion of the protocol treatment.
- Voluntary subjects having history or drugs and/or alcohol abuse.
- Voluntary subjects who are smokers at the time of the screening visit.
- Subjects who have received strong or moderate CYP3A inductors and inhibitors listed in the Appendix A within 7 days prior to the treatment initiation.
- The female subject is pregnant or breastfeeding.
- Bacterial or fungal acute infection requiring intravenous antibiotics at the time of inclusion.
- Moderate or severe liver failure (B or higher Child-Pugh category with qualification 7 or higher).
- Congestive heart failure grade II or higher according to New York Heart Association requiring hospitalization within 12 months prior to registration.
- Unstable angina and/or congestive heart disease within the previous 6 months.
- Severe cardiac arrhythmia with no appropriate control.
- Antecedents of brain hemorrhage or stroke (ACV) or transient ischemic attack within the previous 6 months.
- Myocardial infarction within the previous 6 months.
- Exacerbation of chronic obstructive pulmonary disease or another respiratory disease requiring hospitalization or that precludes the study treatment at the time of inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Single Arm, Phase 1 Study to Assess the Safety of P2Et Extract Obtained From Caesalpinia Spinosa, in Voluntary Subjects in Colombia
Caesalpinia spinosa extract is rich in gallotannins and other well characterized polyphenols and has a major antioxidant activity. The extract shows immunomodulatory activity in healthy animals and anti-tumor activity in animals with breast cancer and melanoma as well.
The use of P2Et in animals with tumors shows a synergistic effect with doxorubicin in drug-resistant cell lines. In addition, an increase in survival of transplanted animals with a TS/A breast cancer tumor model and treated with P2Et, in conjunction with calreticulin increase is observed.
This open-label, single arm, Phase 1 study intends to assess the safety of P2Et extract obtained from Caesalpinia spinosa, with dose escalation, in healthy voluntary participants in Colombia.
Read the detailed description
The P2Et extract will be self-administered by the participants on a daily basis (600 mg 1 daily capsule, 2 daily capsules for 1,200 mg, 4 daily capsules for 2,400 and 8 daily capsules for 4,800 mg) 1 hour after meals and at the same time every day, from day 1 to day 30.
In the event that the participants presents vomit within 15 minutes after taking P2Et, the participants should take another dose. Should the participant forget any scheduled dose and less than 6 hours have elapsed, the participant must take the dose immediately; if more than 6 hours have elapsed, the subject must wait and take the next scheduled dose.
Dose escalation will be performed to determine the P2Et maximum tolerated dose (MTD) and maximum dose toxicity (MDT). In the escalation phase, the P2Et daily dose will be escalated in the cohort of subjects with minimum dose of 600 mg daily to a maximum of 4,800 mg. Each cohort will be made up of around 3 and 6 subjects, at least 3 subjects will be enrolled in each dosage level. Should MTD is not observed in the first 3 subjects treated in the first month, escalation to the next dosage level will be undertaken. Should 1 or more MTD occur in any dosage level in a subject, 3 subjects will be added to that cohort.
Any dosage level in which 2 out of 6 subjects experience a MTD will be considered intolerable and the previous dose will be considered the P2Et maximum tolerated dose (MTD) and dose escalation will be terminated. The 3+3 design will be used monthly for the P2Et dose escalation (up to a maximum of 4.8 g/day).
The participants will be followed-up until withdrawal of the protocol therapy. The participants removed from the protocol due to unacceptable adverse events will be followed-up until resolution or stabilization of the adverse event.
- Conditions
- Toxicity, Safety Issues
- Being tested
- P2Et extract
- Keywords
- Polyphenols, Safety, Herbal Extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P2Et extractDrug
Also called P2Et obtained from Caesalpinia spinosa
P2Et extract daily doses. Dosage scaling will be performed according to the 3 + 3 standard design.
| Study group | Role | What they receive |
|---|---|---|
| P2Et extract | Experimental | P2Et extract daily doses. Dosage scaling will be performed according to the 3 + 3 standard design. Receives: Drug: P2Et extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Identification of the maximum dose toxicity
Measured: 12 months
Secondary outcomes (1)
Immunomodulation
Change between baseline immunological profile percentage and end of the treatment immunological profile percentage with its respective mean, median, standard deviation and range.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start30 Apr 2019
- Primary completion15 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToxicityStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, single arm, Phase 1 study. 24 participants are anticipated, assuming that 6 participants are recruited in each of the levels of dose titration based on the 3 +3 design.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario San Ignacio
- Sponsor type
- University, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Responsible party
- Sponsor
- Investigators
- Lilian Torregrosa Almonacid, MD, Principal investigator, Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663881
- Sponsor's protocol ID
- CS001-SA
- Status last verified
- Mar 2024
- First submitted
- 8 Aug 2018
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single Arm, Phase 1 Study to Assess the Safety of P2Et Extract Obtained From Caesalpinia Spinosa, in Voluntary Subjects in Colombia
- ClinicalTrials.gov ID
- NCT03663881
- Acronym / sponsor ID
- CS001-SA
- Conditions
- Toxicity, Safety Issues
- Keywords
- Polyphenols, Safety, Herbal Extract
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Hospital Universitario San IgnacioUniversity, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 10 Sep 2018 (actual)
- 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.
Caesalpinia spinosa extract is rich in gallotannins and other well characterized polyphenols and has a major antioxidant activity. The extract shows immunomodulatory activity in healthy animals and anti-tumor activity in animals with breast cancer and melanoma as well.
The use of P2Et in animals with tumors shows a synergistic effect with doxorubicin in drug-resistant cell lines. In addition, an increase in survival of transplanted animals with a TS/A breast cancer tumor model and treated with P2Et, in conjunction with calreticulin increase is observed.
This open-label, single arm, Phase 1 study intends to assess the safety of P2Et extract obtained from Caesalpinia spinosa, with dose escalation, in healthy voluntary participants in Colombia.
Detailed description
The P2Et extract will be self-administered by the participants on a daily basis (600 mg 1 daily capsule, 2 daily capsules for 1,200 mg, 4 daily capsules for 2,400 and 8 daily capsules for 4,800 mg) 1 hour after meals and at the same time every day, from day 1 to day 30.
In the event that the participants presents vomit within 15 minutes after taking P2Et, the participants should take another dose. Should the participant forget any scheduled dose and less than 6 hours have elapsed, the participant must take the dose immediately; if more than 6 hours have elapsed, the subject must wait and take the next scheduled dose.
Dose escalation will be performed to determine the P2Et maximum tolerated dose (MTD) and maximum dose toxicity (MDT). In the escalation phase, the P2Et daily dose will be escalated in the cohort of subjects with minimum dose of 600 mg daily to a maximum of 4,800 mg. Each cohort will be made up of around 3 and 6 subjects, at least 3 subjects will be enrolled in each dosage level. Should MTD is not observed in the first 3 subjects treated in the first month, escalation to the next dosage level will be undertaken. Should 1 or more MTD occur in any dosage level in a subject, 3 subjects will be added to that cohort.
Any dosage level in which 2 out of 6 subjects experience a MTD will be considered intolerable and the previous dose will be considered the P2Et maximum tolerated dose (MTD) and dose escalation will be terminated. The 3+3 design will be used monthly for the P2Et dose escalation (up to a maximum of 4.8 g/day).
The participants will be followed-up until withdrawal of the protocol therapy. The participants removed from the protocol due to unacceptable adverse events will be followed-up until resolution or stabilization of the adverse event.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, single arm, Phase 1 study. 24 participants are anticipated, assuming that 6 participants are recruited in each of the levels of dose titration based on the 3 +3 design.
| Arm | Type | Receives |
|---|---|---|
| P2Et extract | Experimental | Drug: P2Et extractP2Et extract daily doses. Dosage scaling will be performed according to the 3 + 3 standard design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age 18 or older
- Adequate renal, hematological, hepatic function defined as:
- Platelets ≥100,000/mm3 (100 × 109/L) and Hemoglobin ≥ 9.0 g/dL in peripheral blood.
- No uncontrolled or significant comorbidities determined by clinical history, physical examination and screening laboratory tests at the discretion of the investigator.
- Women of childbearing age must have a negative pregnancy test (urine or serum) at the time of screening and enrollment.
Key exclusion criteria (28 listed)
- Subjects with one or more of the following conditions are not eligible for this study.
- Subjects receiving any investigational agent and /or taking part in a clinical study in the 30 days prior to the admission or during their participation in the study.
- History of allergic reactions attributed to polyphenol-type compounds similar to those found in green tea.
- Use of dietary supplements or phytopharmaceutical drugs < 15 days prior to the admission and during the study.
- Subjects with diagnosis of an active disease and/or receiving pharmacological treatment prescribed for an active disease and who have evidence of an active disease at the time of the initial clinical examination at the discretion of the investigator.
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 |
|---|---|---|
| P2Et extractAlso: P2Et obtained from Caesalpinia spinosaP2Et extract daily doses. Dosage scaling will be performed according to the 3 + 3 standard design. | Drug | P2Et extract |
Primary outcome
Maximum Tolerated Dose
Time frame: 12 months
Identification of the maximum dose toxicity
1 secondary outcome
Immunomodulation
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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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.
Lilian Torregrosa Almonacid, MD principal investigator
Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing P2Et extract in people with Toxicity and Safety Issues, run by Hospital Universitario San Ignacio at 1 site in Colombia.
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 19 inclusion and 28 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: finished, as of the sponsor's last update on 13 Mar 2024. 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 Colombia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Tolerated Dose (time frame: 12 months). 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 13 Mar 2024.