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

University of Zurich (UZH)

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Hepatocellular Cancer

Cholangiocarcinoma

Colorectal Neoplasms

Pancreatic Neoplasms

Treatments

Drug: OXY111A

Study type

Interventional

Funder types

Other

Identifiers

NCT02528526

OXY1A_2014-0374

Details and patient eligibility

About

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.

Full 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.

Enrollment

69 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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