Back to results

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

Primary Purpose

Neoplasm, Stomach, Gastric Neoplasms Malignant, Pancreatic Neoplasms

Status

Not yet recruiting

Phase

Phase 1

Locations

Colombia

Study Type

Interventional

Intervention

Petiveria Alliacea Preparation

Placebo

About this trial

This is an interventional treatment trial for Neoplasm, Stomach

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Solid Tumors:

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.

Inclusion Criteria Acute Leukemia:

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.
- Patients must be newly diagnosed
- Patients must have failed initial therapy, which may manifest in any of the following ways:
  - Demonstration of primary refractory disease (primary induction failure) as evidenced by mid-cycle bone marrow analysis showing lack of complete tumor clearance (CTC).
  - Relapse of the initial disease after a period of achieving complete remission.
Subject can swallow and retain oral medication and does not have uncontrolled emesis or persistent diarrhea.
Adequate renal, hematological, and hepatic 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. 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):

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).

h) Desire to complete the study and follow-up interventions.

Exclusion Criteria:

The exclusion criteria apply to solid tumors as well as hematological tumors.

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.

Sites / Locations

Pontificia Universidad Javeriana

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Metastatic gastrointestinal tumors and acute leukemia patients

Stage II Metastatic gastrointestinal tumors including pancreas

Stage II Placebo Metastatic gastrointestinal tumors including pancreas

Acute leukemia (Newly/Relapse)

Arm Description

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. 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of life in patients

Changes of at least 5 points above the difference between the groups of the functional scales of the patients evaluated using the EORTC QLQ-C-30 scale

Tumor response

To determine the impact of treatment with Esperanza extract in combination with chemotherapy on the number and size of metastases.

Survival

To determine event/progression-free survival in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and bile ducts) and patients with newly diagnosed and relapsed acute leukemias.

Full Information

NCT ID

NCT05587088

First Posted

October 13, 2022

Last Updated

October 16, 2022

Sponsor

Hospital Universitario San Ignacio

Collaborators

Pontificia Universidad Javeriana

1. Study Identification

Unique Protocol Identification Number

NCT05587088

Brief Title

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

Acronym

PA001

Official Title

Evaluation of the Safety and Efficacy of Esperanza Extract (Petiveria Alliacea) in Patients With Metastatic Gastrointestinal Tumors and Acute Leukemia

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 15, 2022 (Anticipated)

Primary Completion Date

March 15, 2023 (Anticipated)

Study Completion Date

June 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital Universitario San Ignacio

Collaborators

Pontificia Universidad Javeriana

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Anamú, Petiveria alliacea, has been used by traditional medicine to treat leukemia and breast cancer. However, its activity on tumor metabolism makes it a therapeutic candidate for many tumors with alterations in glycolytic metabolism, but also uses the mitochondria to produce energy. Given the glycolytic nature of some tumor cells, the modulating activity of cell metabolism exerted by anamú extract may be partly responsible for the anti-tumor activity. Previous reports show that some patients with ALL or AML whose response to treatment was evaluated in vitro are sensitive to a standardized extract of Petiveria alliacea. Even more interesting is the fact that when we treat the cells with allopathic therapy, explicitly established for each of these pathologies, the sensitivity of the blasts increases when they are treated concomitantly with the extract, which suggests that the intrinsic resistance of each one of tumor cells in the different tissues evaluated can be reduced by the action of the phytomedicine. The same thing was observed when spheres obtained from human breast cancer were co-treated with the anamú extract and anthracyclines. These observations allow to validate the traditional use of anamú in the treatment of some tumors, such as leukemia and breast cancer, among others. However, to observe the safety and effects on patients, it is necessary to develop a clinical study that would allow the anamú phytomedicine produced in the appropriate pharmaceutical conditions, to be included as a complementary therapy based on a standardized extract of the plant and that can overcome the resistance of tumor cells to conventional treatments, improving response and increasing overall survival of patients in Colombia. Although the explosion of new therapies in solid tumors and hematological alterations is not so high, countries such as Germany, France, and Italy have used traditional medicine from which herbal pharmaceutical preparations are derived in the treatment of different types of diseases, including cancer. , estimating the use of these products between 30 and 75% of patients worldwide. These herbal products are mainly used to reduce allopathic therapies' side effects and organic toxicity, protect and stimulate the immune system, or prevent future neoplasms or their recurrence. Currently, various extracts from natural products are in clinical trials in the United States, and there is significant evidence about some plants' role in leukemia's evolution. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigator

Masking Description

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.

Allocation

Randomized

Enrollment

82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Metastatic gastrointestinal tumors and acute leukemia patients

Arm Type

Experimental

Arm Description

Arm Title

Stage II Metastatic gastrointestinal tumors including pancreas

Arm Type

Experimental

Arm Description

Arm Title

Stage II Placebo Metastatic gastrointestinal tumors including pancreas

Arm Type

Placebo Comparator

Arm Description

Arm Title

Acute leukemia (Newly/Relapse)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Petiveria Alliacea Preparation

Intervention Description

Petiveria Alliacea Preparation in pill

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo in pill

Primary Outcome Measure Information:

Title

Safety and efficacy

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Quality of life in patients

Description

Changes of at least 5 points above the difference between the groups of the functional scales of the patients evaluated using the EORTC QLQ-C-30 scale

Time Frame

12 months

Title

Tumor response

Description

To determine the impact of treatment with Esperanza extract in combination with chemotherapy on the number and size of metastases.

Time Frame

12 months

Title

Survival

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Solid Tumors: 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. Inclusion Criteria Acute Leukemia: 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. Patients must be newly diagnosed Patients must have failed initial therapy, which may manifest in any of the following ways: Demonstration of primary refractory disease (primary induction failure) as evidenced by mid-cycle bone marrow analysis showing lack of complete tumor clearance (CTC). Relapse of the initial disease after a period of achieving complete remission. Subject can swallow and retain oral medication and does not have uncontrolled emesis or persistent diarrhea. Adequate renal, hematological, and hepatic 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. 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). h) Desire to complete the study and follow-up interventions. Exclusion Criteria: The exclusion criteria apply to solid tumors as well as hematological tumors. 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.

Facility Information:

Facility Name

Pontificia Universidad Javeriana

City

Bogotá

ZIP/Postal Code

110221

Country

Colombia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29506548

Citation

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.

Results Reference

result

PubMed Identifier

33184339

Citation

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.

Results Reference

result

PubMed Identifier

20371346

Citation

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.

Results Reference

result

PubMed Identifier

33462499

Citation

Bergers G, Fendt SM. The metabolism of cancer cells during metastasis. Nat Rev Cancer. 2021 Mar;21(3):162-180. doi: 10.1038/s41568-020-00320-2. Epub 2021 Jan 18.

Results Reference

result

PubMed Identifier

25621950

Citation

Fong MY, Zhou W, Liu L, Alontaga AY, Chandra M, Ashby J, Chow A, O'Connor ST, Li S, Chin AR, Somlo G, Palomares M, Li Z, Tremblay JR, Tsuyada A, Sun G, Reid MA, Wu X, Swiderski P, Ren X, Shi Y, Kong M, Zhong W, Chen Y, Wang SE. Breast-cancer-secreted miR-122 reprograms glucose metabolism in premetastatic niche to promote metastasis. Nat Cell Biol. 2015 Feb;17(2):183-94. doi: 10.1038/ncb3094. Epub 2015 Jan 26.

Results Reference

result

PubMed Identifier

28412099

Citation

Eddy RJ, Weidmann MD, Sharma VP, Condeelis JS. Tumor Cell Invadopodia: Invasive Protrusions that Orchestrate Metastasis. Trends Cell Biol. 2017 Aug;27(8):595-607. doi: 10.1016/j.tcb.2017.03.003. Epub 2017 Apr 12.

Results Reference

result

PubMed Identifier

31739095

Citation

Kang X, Wang J, Li C. Exposing the Underlying Relationship of Cancer Metastasis to Metabolism and Epithelial-Mesenchymal Transitions. iScience. 2019 Nov 22;21:754-772. doi: 10.1016/j.isci.2019.10.060. Epub 2019 Oct 31.

Results Reference

result

PubMed Identifier

25983002

Citation

Xian ZY, Liu JM, Chen QK, Chen HZ, Ye CJ, Xue J, Yang HQ, Li JL, Liu XF, Kuang SJ. Inhibition of LDHA suppresses tumor progression in prostate cancer. Tumour Biol. 2015 Sep;36(10):8093-100. doi: 10.1007/s13277-015-3540-x. Epub 2015 May 16.

Results Reference

result

PubMed Identifier

27916294

Citation

Zhu J, Ma J, Wang X, Ma T, Zhang S, Wang W, Zhou X, Shi J. High Expression of PHGDH Predicts Poor Prognosis in Non-Small Cell Lung Cancer. Transl Oncol. 2016 Dec;9(6):592-599. doi: 10.1016/j.tranon.2016.08.003.

Results Reference

result

PubMed Identifier

32711004

Citation

Butler LM, Perone Y, Dehairs J, Lupien LE, de Laat V, Talebi A, Loda M, Kinlaw WB, Swinnen JV. Lipids and cancer: Emerging roles in pathogenesis, diagnosis and therapeutic intervention. Adv Drug Deliv Rev. 2020;159:245-293. doi: 10.1016/j.addr.2020.07.013. Epub 2020 Jul 23.

Results Reference

result

PubMed Identifier

16564913

Citation

Shah US, Dhir R, Gollin SM, Chandran UR, Lewis D, Acquafondata M, Pflug BR. Fatty acid synthase gene overexpression and copy number gain in prostate adenocarcinoma. Hum Pathol. 2006 Apr;37(4):401-9. doi: 10.1016/j.humpath.2005.11.022. Epub 2006 Feb 7.

Results Reference

result

PubMed Identifier

31819192

Citation

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.

Results Reference

result

PubMed Identifier

28415728

Citation

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.

Results Reference

result

PubMed Identifier

24497570

Citation

Zadra G, Photopoulos C, Tyekucheva S, Heidari P, Weng QP, Fedele G, Liu H, Scaglia N, Priolo C, Sicinska E, Mahmood U, Signoretti S, Birnberg N, Loda M. A novel direct activator of AMPK inhibits prostate cancer growth by blocking lipogenesis. EMBO Mol Med. 2014 Apr;6(4):519-38. doi: 10.1002/emmm.201302734. Epub 2014 Feb 4. Erratum In: EMBO Mol Med. 2014 Oct;6(10):1357.

Results Reference

result

PubMed Identifier

27347147

Citation

Song K, Li M, Xu X, Xuan LI, Huang G, Liu Q. Resistance to chemotherapy is associated with altered glucose metabolism in acute myeloid leukemia. Oncol Lett. 2016 Jul;12(1):334-342. doi: 10.3892/ol.2016.4600. Epub 2016 May 17.

Results Reference

result

PubMed Identifier

24641416

Citation

Song K, Li M, Xu XJ, Xuan L, Huang GN, Song XL, Liu QF. HIF-1alpha and GLUT1 gene expression is associated with chemoresistance of acute myeloid leukemia. Asian Pac J Cancer Prev. 2014;15(4):1823-9. doi: 10.7314/apjcp.2014.15.4.1823.

Results Reference

result

PubMed Identifier

20959411

Citation

Herst PM, Howman RA, Neeson PJ, Berridge MV, Ritchie DS. The level of glycolytic metabolism in acute myeloid leukemia blasts at diagnosis is prognostic for clinical outcome. J Leukoc Biol. 2011 Jan;89(1):51-5. doi: 10.1189/jlb.0710417. Epub 2010 Oct 19.

Results Reference

result

PubMed Identifier

28161329

Citation

Guerra F, Arbini AA, Moro L. Mitochondria and cancer chemoresistance. Biochim Biophys Acta Bioenerg. 2017 Aug;1858(8):686-699. doi: 10.1016/j.bbabio.2017.01.012. Epub 2017 Feb 1.

Results Reference

result

PubMed Identifier

35582564

Citation

Bokil A, Sancho P. Mitochondrial determinants of chemoresistance. Cancer Drug Resist. 2019 Sep 19;2(3):634-646. doi: 10.20517/cdr.2019.46. eCollection 2019.

Results Reference

result

PubMed Identifier

31409768

Citation

Panina SB, Baran N, Brasil da Costa FH, Konopleva M, Kirienko NV. A mechanism for increased sensitivity of acute myeloid leukemia to mitotoxic drugs. Cell Death Dis. 2019 Aug 13;10(8):617. doi: 10.1038/s41419-019-1851-3.

Results Reference

result

PubMed Identifier

25631767

Citation

Sriskanthadevan S, Jeyaraju DV, Chung TE, Prabha S, Xu W, Skrtic M, Jhas B, Hurren R, Gronda M, Wang X, Jitkova Y, Sukhai MA, Lin FH, Maclean N, Laister R, Goard CA, Mullen PJ, Xie S, Penn LZ, Rogers IM, Dick JE, Minden MD, Schimmer AD. AML cells have low spare reserve capacity in their respiratory chain that renders them susceptible to oxidative metabolic stress. Blood. 2015 Mar 26;125(13):2120-30. doi: 10.1182/blood-2014-08-594408. Epub 2015 Jan 28.

Results Reference

result

PubMed Identifier

31432232

Citation

Yang J, Ren B, Yang G, Wang H, Chen G, You L, Zhang T, Zhao Y. The enhancement of glycolysis regulates pancreatic cancer metastasis. Cell Mol Life Sci. 2020 Jan;77(2):305-321. doi: 10.1007/s00018-019-03278-z. Epub 2019 Aug 20.

Results Reference

result

PubMed Identifier

25805929

Citation

Donadelli M, Dando I, Dalla Pozza E, Palmieri M. Mitochondrial uncoupling protein 2 and pancreatic cancer: a new potential target therapy. World J Gastroenterol. 2015 Mar 21;21(11):3232-8. doi: 10.3748/wjg.v21.i11.3232.

Results Reference

result

PubMed Identifier

22589701

Citation

Lu W, Hu Y, Chen G, Chen Z, Zhang H, Wang F, Feng L, Pelicano H, Wang H, Keating MJ, Liu J, McKeehan W, Wang H, Luo Y, Huang P. Novel role of NOX in supporting aerobic glycolysis in cancer cells with mitochondrial dysfunction and as a potential target for cancer therapy. PLoS Biol. 2012;10(5):e1001326. doi: 10.1371/journal.pbio.1001326. Epub 2012 May 8. Erratum In: PLoS Biol. 2017 Dec 11;15(12 ):e1002616.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs