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

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Brief Title

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

Official Title

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

Brief Summary

      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

      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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Safety and tolerability as measured by collection of adverse effects information

Secondary Outcome

 Efficacy as measured by FDG-PET scan

Condition

Pancreatic Neoplasms

Intervention

OXY111A

Study Arms / Comparison Groups

 Treatment
Description:  Add-on application of Myo-inositol trispyrophosphate, total of 9 times, 3 applications per week, over 3 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

69

Start Date

February 2014

Completion Date

December 2016

Primary Completion Date

December 2016

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Pierre Alain, Clavien, +41 (0)44 255 33 00, [email protected]

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT02528526

Organization ID

OXY1A_2014-0374


Responsible Party

Sponsor

Study Sponsor

University of Zurich


Study Sponsor

Pierre Alain, Clavien, Principal Investigator, University Hospital Zurich, Visceral Surgery


Verification Date

August 2015