Effects of OXY111A in Primary and Secondary Hepato-Pancreato-Biliary Neoplasm

Study Overview
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Brief Summary
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The purpose of the study is to evaluate whether the novel anti-cancer drug OXY111A is safe and tolerated in patients with primary and secondary hepato-pancreato-biliary and gastrointestinal neoplasia as measured by exploring the maximum tolerated dose (MTD). At level of MTD, additional patients will be included aimed for assessing the efficacy profile in these neoplasia entities.

Detailed Description
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The IMP OXY111A counteracts hypoxia-induced tumor aggressiveness showing decreased tumor burden and increased survival in five different animal solid tumor models both applied as monotherapy and increased beneficial effects when followed by standard chemotherapy. The unique ability of the IMP counteract hypoxic tumor behaviour along with its non-toxic side effects tested both in animals and healthy volunteers is of outmost interest to explore in patients with solid tumors. The study seeks primarily to determine the safety and tolerability of OXY111A in patients with primary and secondary hepato-pancreato-biliary and gastrointestinal neoplasia as measured by exploring the MTD in a conservative 3+3 dose escalation schedule. The window for DLT assessment is from first dose of study drug until first dose of standard of care chemotherapy or 10 days following completion of last dose of study drug (whichever is shorter in duration). Additionally, we will assess efficacy of OXY111A on decreasing tumor volume, metabolic activity, as well as circulatory tumor and angiogenic markers.

Official Title
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A Phase IB/IIA, Single-centered Study of the Effects of OXY111A in Primary and Secondary Hepato-Pancreato-Biliary Neoplasia

Conditions
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Pancreatic Neoplasms, Hepatocellular Cancer, Cholangiocarcinoma, Colorectal Neoplasms

Intervention / Treatment
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* Drug: OXY111A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Study Indication: patients diagnosed for non-resectable hepato-pancreato-biliary or gastrointestinal neoplasm Male and Female patients ≥ 18 years of age Signed Informed Consent after being informed Eastern Cooperative Oncology Group (ECOG) performance status score of ≥ 2 at study entry. A life-expectancy of >3 months Adequate hematologic and renal function Use of effective contraception (per the institutional standard), if procreative potential exists Adequate recovery from recent surgery, chemotherapy, and radiation therapy. At least 28 days must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy (palliative radiation therapy is allowed) Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center Exclusion Criteria: Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product Women who are pregnant or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Add-on application of Myo-inositol trispyrophosphate, total of 9 times, 3 applications per week, over 3 weeks. | Drug: OXY111A<br>* OXY111A intravenous infusion<br>* Other names: Myo-inositol trispyrophosphate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as measured by collection of adverse effects information | Safety variables and patient tolerance as measured by collection of adverse effects information according to Common Terminology Criteria for Adverse Events (CTCAE) | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as measured by FDG-PET scan | Assessment of tumor response with 18F-FDG PET in FDG-avid tumors using EORTC criteria | 5 months | 
| Efficacy as measured by MRI | Assessment of tumor response with MRI in non-FDG-avid tumors using RECIST criteria | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypoxia, Pancreatic Neoplasms, Hepatocellular Cancer, Cholangiocarcinoma, Colorectal Neoplasms, Treatment