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

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Treatments: Inositol

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