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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02528526
Recruitment Status : Unknown
Verified August 2015 by University of Zurich.
Recruitment status was:  Recruiting
First Posted : August 19, 2015
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Hepatocellular Cancer Cholangiocarcinoma Colorectal Neoplasms Drug: OXY111A Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IB/IIA, Single-centered Study of the Effects of OXY111A in Primary and Secondary Hepato-Pancreato-Biliary Neoplasia
Study Start Date : February 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Inositol

Arms and Interventions
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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 Name: Myo-inositol trispyrophosphate


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. Efficacy as measured by MRI [ Time Frame: 5 months ]
    Assessment of tumor response with MRI in non-FDG-avid tumors using RECIST criteria


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02528526


Contacts
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Contact: Pierre-Alain Clavien, MD, PhD +41 (0)44 255 33 00 clavien@access.uzh.ch
Contact: Perparim Limani, MD +41 (0)44 255 33 00 perparim.limani@usz.ch

Locations
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Switzerland
University Hospital Zurich, Visceral Surgery Recruiting
Zurich, ZH, Switzerland, 8091
Contact: Pierre-Alain Clavien, MD, PhD    +41 (0)44 255 33 00    clavien@access.uzh.ch   
Contact: Perparim Limani, MD    +41 (0)44 255 33 00    perparim.limani@usz.ch   
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         
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Pierre Alain, Clavien University Hospital Zurich, Visceral Surgery
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02528526    
Other Study ID Numbers: OXY1A_2014-0374
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015
Keywords provided by University of Zurich:
Hypoxia
Pancreatic Neoplasms
Hepatocellular Cancer
 Cholangiocarcinoma
Colorectal Neoplasms
Treatment
Additional relevant MeSH terms:
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Neoplasms
Cholangiocarcinoma
Colorectal Neoplasms
Pancreatic Neoplasms
Liver Neoplasms
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Liver Diseases
Inositol
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs