Effects of OXY111A in Primary and Secondary Hepato-Pancreato-Biliary Neoplasm (OXY1A)

August 18, 2015 updated by: University of Zurich

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

69

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • Recruiting
        • University Hospital Zurich, Visceral surgery
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Panagiotis Samaras, MD
        • Sub-Investigator:
          • Bernhard Pestalozzi, MD
        • Sub-Investigator:
          • Alexander Jetter, MD
        • Sub-Investigator:
          • Michael Linecker, MD
        • Sub-Investigator:
          • Rolf Graf, PhD
        • Sub-Investigator:
          • Bostjan Humar, PhD
        • Sub-Investigator:
          • Henrik Petrowsky, MD
        • Sub-Investigator:
          • Philipp Kron, MD
        • Sub-Investigator:
          • Roger Stupp, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Add-on application of Myo-inositol trispyrophosphate, total of 9 times, 3 applications per week, over 3 weeks.
Drug: OXY111A
OXY111A intravenous infusion
Other Names:
  • Myo-inositol trispyrophosphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability as measured by collection of adverse effects information
Time Frame: 10 weeks
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
Time Frame: 5 months
Assessment of tumor response with 18F-FDG PET in FDG-avid tumors using EORTC criteria
5 months
Efficacy as measured by MRI
Time Frame: 5 months
Assessment of tumor response with MRI in non-FDG-avid tumors using RECIST criteria
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Pierre Alain, Clavien, University Hospital Zurich, Visceral surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

November 11, 2014

First Submitted That Met QC Criteria

August 18, 2015

First Posted (Estimate)

August 19, 2015

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXY1A_2014-0374

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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