Safety Assessment of P2Et Extract in Healthy Voluntary Subjects in Colombia

Safety Issues Clinical Trial

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

Status Completed

Clinical 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.

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Safety Issues
• Toxicity

• NCT number: NCT03663881
• Study type: Interventional
• Source: Hospital Universitario San Ignacio
• Status: Completed
• Phase: Phase 1
• Start date: April 30, 2019
• Completion date: May 15, 2020