Trial reportBMC cancer2016
Development of OXY111A, a novel hypoxia-modifier as a potential antitumor agent in patients with hepato-pancreato-biliary neoplasms - Protocol of a first Ib/IIa clinical trial.
Trial report in BMC cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02528526 (A Phase IB/IIA, Single-centered Study of the Effects of OXY111A in Primary and Secondary Hepato-Pancreato-Biliary Neoplasia), which is not on this map. Cited by 12 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase IB/IIA, Single-centered Study of the Effects of OXY111A in Primary and Secondary Hepato-Pancreato-Biliary Neoplasia
Who cites it
12 citing papers in PubMed, 19 citations in OpenAlex.
- Review
- Immunotherapy improved cancer related pain management in patients with advanced Hepato-Pancreatic Biliary Cancers: A propensity score-matched (PSM) analysis.Frontiers in oncology · 2022Article
- The Role of Imaging Biomarkers to Guide Pharmacological Interventions Targeting Tumor Hypoxia.Frontiers in pharmacology · 2022Review
- Immunology and Immunotherapy of Endometriosis.Journal of clinical medicine · 2021Review
- Phase Ib dose-escalation study of the hypoxia-modifier Myo-inositol trispyrophosphate in patients with hepatopancreatobiliary tumors.Nature communications · 2021Article
- Novel therapies targeting hypoxia mechanism to treat pancreatic cancer.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2021Article
- Cancer Prevention by Natural Products Introduced into the Diet-Selected Cyclitols.International journal of molecular sciences · 2020Review
- Hypoxia: Friend or Foe for drug delivery in Pancreatic Cancer.Cancer letters · 2020Review
- Combined endogenous MR biomarkers to assess changes in tumor oxygenation induced by an allosteric effector of hemoglobin.NMR in biomedicine · 2020Article
- Review
- WWOX controls hepatic HIF1α to suppress hepatocyte proliferation and neoplasia.Cell death & disease · 2018Article
- Hypoxia inducible factors in hepatocellular carcinoma.Oncotarget · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSolid tumors, such as hepato-pancreato-biliary cancer, develop tumor hypoxia with tumor growth. Despite advances in surgery, a majority of these patients are in an unresectable condition. At this stage standard cytotoxic chemotherapy regimens are applied with limited success. Novel biological treatment options based on an antiangiogenic mechanism of action neglect other hypoxia mediated mechanisms (e.g. epithelial-mesenchymal transition, Warburg effect, and immunological response) leading to an increased invasiveness with a poor outcome. The novel antihypoxic molecule myo-inositoltrispyrophosphate (ITPP, OXY111A) acts as an allosteric effector of hemoglobin and promotes normoxia in hypoxic tumors. In preclinical studies, tumor growth was reduced and survival prolonged. Additionally, a beneficial side effect profile was observed.
methodsIn this first Ib/IIa clinical trial we will assess safety and tolerability of OXY111A as well as a proof of concept regarding efficacy in patients with non-resectable primary and secondary tumors of the liver, pancreas, and biliary tract. The study design is exploratory, prospective, open-labelled and mono-centric. The study is divided in a dose escalation part with a maximum of 48 subjects and an extension part, in which 21 subjects will be included. DISCUSSION: The novel antihypoxic compound OXY111A has been tested in several cancer animal models showing beneficial effects for both survival and low side effect profiles. This first in patient application of OXY111A will reveal potential beneficial outcomes if anti-hypoxic therapy is added to standard cytotoxic treatment in patients with primary and secondary hepatopancreatobiliary tumors.
trial registrationInstitution Ethical Board Approval ID: KEK-ZH-Nr. 2014-0374; Swiss regulatory authority Swissmedic (2015DR1009); ClinicalTrials.gov Identifier: NCT02528526 , prospectively registered on November 11
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