Trials / Unknown
UnknownNCT02528526
Effects of OXY111A in Primary and Secondary Hepato-Pancreato-Biliary Neoplasm
A Phase IB/IIA, Single-centered Study of the Effects of OXY111A in Primary and Secondary Hepato-Pancreato-Biliary Neoplasia
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 69 (estimated)
- Sponsor
- University of Zurich · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OXY111A | OXY111A intravenous infusion |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2016-12-01
- Completion
- 2016-12-01
- First posted
- 2015-08-19
- Last updated
- 2015-08-19
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT02528526. Inclusion in this directory is not an endorsement.