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Evaluation of the Safety and Efficacy of Esperanza Extract (PA001)

NCT05587088 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2022-10-19

No results posted yet for this study

Summary

This is a phase Ib/II clinical study that has two phases. In phase Ib, the safety evaluation of the extract of Petiveria alliacea (Esperanza) will be carried out in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and biliary tract) and patients with newly diagnosed and relapsed acute leukemia. In phase IIb, the safety will continue to be evaluated, and the efficacy of the Esperanza extract will be explored in combination with chemotherapy in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and biliary tract) with newly diagnosed acute leukemias and relapses.

Conditions

  • Neoplasm, Stomach
  • Gastric Neoplasms Malignant
  • Pancreatic Neoplasms
  • Colorectal Neoplasms
  • Acute Leukemia
  • Acute Leukemia in Relapse
  • Acute Leukemia Lymphoid
  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia, in Relapse

Interventions

DRUG

Petiveria Alliacea Preparation

Petiveria Alliacea Preparation in pill

DRUG

Placebo

Placebo in pill

Sponsors & Collaborators

  • Pontificia Universidad Javeriana

    collaborator OTHER

  • Hospital Universitario San Ignacio

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2023-03-15
Completion
2023-06-15

Countries

  • Colombia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05587088 on ClinicalTrials.gov