NCT05587088|UnknownPhase 1/2
Evaluation of the Safety and Efficacy of Esperanza Extract (PA001)
PA001
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PA001
Sponsor study identifier
interventional
82
1 country
1
Study Start
December 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 15, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 15, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 15, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 13, 2022
Actual (reported)October 19, 2022
Actual (reported)December 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 15, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 15, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Quality of life in patients
12 months
Tumor response
12 months
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.
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.
Petiveria Alliacea Preparation in pill
Placebo in pill
Pontificia Universidad Javeriana
Bogotá, 110221, Colombia
Di Martino MT, Zazzeroni F, Donadelli M, Chiodoni C, Caraglia M, Scotlandi K, Meschini S, Leonetti C. Reprogramming Tumor-Immune Cell Interface in Solid and Hematological Malignancies to Enhance Response to Therapy. J Exp Clin Cancer Res. 2018 Mar 5;37(1):48. doi: 10.1186/s13046-018-0710-x. No abstract available.
Uruena C, Sandoval TA, Lasso P, Tawil M, Barreto A, Torregrosa L, Fiorentino S. Evaluation of chemotherapy and P2Et extract combination in ex-vivo derived tumor mammospheres from breast cancer patients. Sci Rep. 2020 Nov 12;10(1):19639. doi: 10.1038/s41598-020-76619-9.
First Submitted
October 13, 2022
A Phase I-II Study Investigating the All-Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine/Cedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE)
Survival
12 months
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Sharma SV, Lee DY, Li B, Quinlan MP, Takahashi F, Maheswaran S, McDermott U, Azizian N, Zou L, Fischbach MA, Wong KK, Brandstetter K, Wittner B, Ramaswamy S, Classon M, Settleman J. A chromatin-mediated reversible drug-tolerant state in cancer cell subpopulations. Cell. 2010 Apr 2;141(1):69-80. doi: 10.1016/j.cell.2010.02.027.
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Koundouros N, Poulogiannis G. Reprogramming of fatty acid metabolism in cancer. Br J Cancer. 2020 Jan;122(1):4-22. doi: 10.1038/s41416-019-0650-z. Epub 2019 Dec 10.
Itkonen HM, Brown M, Urbanucci A, Tredwell G, Ho Lau C, Barfeld S, Hart C, Guldvik IJ, Takhar M, Heemers HV, Erho N, Bloch K, Davicioni E, Derua R, Waelkens E, Mohler JL, Clarke N, Swinnen JV, Keun HC, Rekvig OP, Mills IG. Lipid degradation promotes prostate cancer cell survival. Oncotarget. 2017 Jun 13;8(24):38264-38275. doi: 10.18632/oncotarget.16123.
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Ballesteros-Ramirez R, Pinilla P, Sanchez J, Arevalo M, Sanchez E, Aschner P, Uruena C, Fiorentino S. Exploring the safety and efficacy of phytomedicine Petiveria alliacea extract (Esperanza) in patients with metastatic gastrointestinal tumors and acute leukemias: study protocol for a phase Ib/randomized double blind phase II trial (PA001). BMC Complement Med Ther. 2023 Aug 10;23(1):284. doi: 10.1186/s12906-023-04109-2.
First Posted
October 19, 2022
Study Start
December 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 15, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 15, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 19, 2022
Record last verified: 2022-10
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