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Safety Assessment of P2Et Extract in Healthy Voluntary Subjects in Colombia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663881
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
Pontificia Universidad Javeriana
Information provided by (Responsible Party):
Hospital Universitario San Ignacio

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Toxicity Safety Issues Drug: P2Et extract Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : April 30, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: P2Et extract
P2Et extract daily doses. Dosage scaling will be performed according to the 3 + 3 standard design.
Drug: P2Et extract
P2Et extract daily doses. Dosage scaling will be performed according to the 3 + 3 standard design.
Other Name: P2Et obtained from Caesalpinia spinosa




Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: 12 months ]
    Identification of the maximum dose toxicity


Secondary Outcome Measures :
  1. Immunomodulation [ Time Frame: 12 months ]
    Change between baseline immunological profile percentage and end of the treatment immunological profile percentage with its respective mean, median, standard deviation and range.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18 or older
  2. 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).

    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.

  3. No uncontrolled or significant comorbidities determined by clinical history, physical examination and screening laboratory tests at the discretion of the investigator.
  4. Women of childbearing age must have a negative pregnancy test (urine or serum) at the time of screening and enrollment.
  5. 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):

    1. 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);
    2. Vasectomized partner of a female subject.
    3. Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to the administration of the study drug;
    4. Intrauterine device (IUD)
    5. Double barrier method (condom, contraceptive sponge, diaphragm or vaginal ring with spermicidal gel or foam).
  6. Willingness to complete the study interventions and follow-up.
  7. 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.

Exclusion Criteria:

Subjects with one or more of the following conditions are not eligible for this study.

  1. 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.
  2. History of allergic reactions attributed to polyphenol-type compounds similar to those found in green tea.
  3. Use of dietary supplements or phytopharmaceutical drugs < 15 days prior to the admission and during the study.
  4. 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.
  5. Severe, active concomitant morbidity, including but not limited to:

    • 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.
  6. Voluntary subjects having history or drugs and/or alcohol abuse.
  7. Voluntary subjects who are smokers at the time of the screening visit.
  8. Subjects who have received strong or moderate CYP3A inductors and inhibitors listed in the Appendix A within 7 days prior to the treatment initiation.
  9. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663881


Contacts
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Contact: Maria Margarita Manrique, MSC 57 1 5946161 ext 2475 mmmanrique@husi.org.co

Locations
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Colombia
Hospital Universitario San Ignacio Recruiting
Bogotá, Colombia, 110221
Contact: Lilian Torregrosa, MD    5946161 ext 2240    ltorregrosa@husi.org.co   
Contact: Marìa M Manrique, MSC    5946161 ext 2475    mmmanrique@husi.org.co   
Principal Investigator: Lilian Torregrosa, Dr         
Sponsors and Collaborators
Hospital Universitario San Ignacio
Pontificia Universidad Javeriana
Investigators
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Principal Investigator: Lilian Torregrosa Almonacid, MD Surgeon
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Responsible Party: Hospital Universitario San Ignacio
ClinicalTrials.gov Identifier: NCT03663881    
Other Study ID Numbers: CS001-SA
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Universitario San Ignacio:
Polyphenols
Safety
Herbal Extract