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

NCT05587088 | Unknown Phase 1

• 1 other identifier: PA001
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Safety and efficacy

  Evaluate the adverse drug reactions of cancer patients treated with anamú extract and chemotherapy through the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

  12 months

Secondary Outcomes (3)

• Quality of life in patients

  12 months

• Tumor response

  12 months

• Survival

  12 months

Study Arms (4)

Metastatic gastrointestinal tumors and acute leukemia patients

EXPERIMENTAL

Patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and bile ducts) and newly diagnosed/relapse acute leukemias who meet the inclusion criteria will take the anamu extract with chemotherapy to evaluate the adverse drug-related side effects.

Drug: Petiveria Alliacea Preparation

Stage II Metastatic gastrointestinal tumors including pancreas

EXPERIMENTAL

For solid metastatic tumors, 30 patients will be recruited, which can be from the colon, pancreas, stomach, and bile ducts, divided into two groups of 15 patients, an intervention group and a placebo group. The intervention group will receive the Esperanza extract at DMT for three continuous treatment cycles (approximately 12 weeks), and the other group will receive the placebo.

Drug: Petiveria Alliacea Preparation

Stage II Placebo Metastatic gastrointestinal tumors including pancreas

PLACEBO COMPARATOR

For solid metastatic tumors, 30 patients will be recruited, which can be from the colon, pancreas, stomach, and bile ducts, divided into two groups of 15 patients, an intervention group and a placebo group. The intervention group will receive the Esperanza extract at DMT for three continuous treatment cycles (approximately 12 weeks), and the other group will receive the placebo. Both groups will receive standard chemotherapy treatment for their underlying disease. The safety evaluation will be carried out in each treatment cycle, and the efficacy evaluation will be carried out at the end of the three cycles.

Drug: Placebo

Acute leukemia (Newly/Relapse)

EXPERIMENTAL

For newly diagnosed hematological tumors, 28 patients will be recruited and will receive the Esperanza extract at DMT. The intervention group will continuously receive the Esperanza extract at DMT for four weeks with the standard chemotherapy regimen for their underlying disease. The safety and efficacy evaluation will be carried out at the end of the treatment cycle. Patients with relapsed or refractory acute leukemias will be admitted to receive the calculated DMT in phase Ib; A total of 6 patients will be recruited, and safety and efficacy evaluations will be performed during three treatment cycles or progression and death of the patient. For the analysis of the response in patients with acute leukemia, a comparison will be made with a group followed historically. A propensity score matching will be performed for statistical analysis in case of differences in their baseline characteristics.

Drug: Petiveria Alliacea Preparation

Interventions

Petiveria Alliacea Preparation DRUG

Petiveria Alliacea Preparation in pill

Acute leukemia (Newly/Relapse); Metastatic gastrointestinal tumors and acute leukemia patients; Stage II Metastatic gastrointestinal tumors including pancreas

Placebo DRUG

Placebo in pill

Stage II Placebo Metastatic gastrointestinal tumors including pancreas

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be over 18 years of age, with no upper age limit
• Histological diagnosis of gastrointestinal cancer may include stomach, colon, bile ducts, and pancreas.
• Measurable disease through diagnostic tests and who will receive chemotherapy as primary treatment for their disease.
• At least one discrete metastatic site identified
• ECOG scale status from 0 to 2 with survival more significant than two months.
• Subject can swallow and retain oral medication and does not have uncontrolled emesis or persistent diarrhea.
• Adequate renal, hematological, hepatic, and cardiac function at the investigator's discretion.
• Without uncontrolled or significant comorbidities determined by clinical history, physical examination, and screening laboratories at the investigator's discretion.
• Patients of childbearing age and without safe non-hormonal planning methods must have a negative pregnancy test before the screening.
• Fertile female subjects (those who have not been postmenopausal for at least 12 months or are surgically sterile by bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) and their male partners must use at least one of the contraceptive methods listed below during study entry, throughout the study, and for at least six months after use of the P2Et extract (the effects of the P2Et extract on the developing human fetus are unknown):
• a. Complete abstinence from sexual intercourse, beginning at least one complete menstrual cycle before administration of study drug; (It should be noted: sexual abstinence as a contraceptive method should be limited to those cases where it is already established as the patient's pre-existing lifestyle choice).
• b. Vasectomy in the partner of a female subject c. Intrauterine device (IUD) d. Double-barrier method (condom, contraceptive sponge, diaphragm, or vaginal ring with spermicidal jelly or cream).
• k) Desire to complete the study and follow-up interventions.
• Patients must be over 18 years of age, with no upper age limit
• Patients who have had a new diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) will be eligible for the study and are eligible for chemotherapy treatment.

You may not qualify if:

• Subjects with one or more conditions are not eligible for this study.
• Subjects treated in any other therapeutic clinical protocol 30 days prior to study entry or during study participation.
• Patients receiving other investigational agents.
• The female subject is pregnant or nursing. A negative serum or urine pregnancy test obtained at screening should confirm that the woman is not pregnant. Pregnancy tests are not required for postmenopausal or surgically sterilized women.
• Serious concomitant morbidity, active at the discretion of the investigator
• Subjects with a confirmed diagnosis of HIV before enrollment or a positive diagnosis of HIV at the time of screening.
• Recipients of solid organ transplants.
• Any condition that, in the opinion of the principal investigator, makes the subject ineligible to participate in this study.

Sponsors & Collaborators

• Hospital Universitario San Ignacio: lead
• Pontificia Universidad Javeriana: collaborator

Study Sites (1)

Pontificia Universidad Javeriana

Bogotá, 110221, Colombia

Location

Related Publications (25)

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MeSH Terms

Conditions

Stomach Neoplasms; Pancreatic Neoplasms; Colorectal Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: At the screening visit, all subjects will be randomly assigned a unique subject number (e.g., 001,002,003, etc.). Enrolled subjects will retain the subject number assigned at Screening Visit throughout the study. In phase Ib, no randomization will be performed. All subjects will receive the therapy chosen by the treating physician. Patients enrolled in phase II will be randomized through the application built in the eCRF in RedCap® for this purpose. Participant, care provider and Investigator will be blind.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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) and patients with newly diagnosed acute leukemias and relapses

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 19, 2022
• Study Start: December 15, 2022
• Primary Completion: March 15, 2023
• Study Completion: June 15, 2023
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)