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