Phase I Trial of ONX-0801 Once Weekly or Alternate Weekly

Exclusion Criteria

• •Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas, Mitomycin-C) and 4 weeks for investigational medicinal products) before treatment.
• •Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 1 toxicities, which in the opinion of the Investigator and the DDU should not exclude the patient
• •Patients with new brain metastases. Patients with treated (surgically excised or irradiated) and stable brain metastases are eligible as long as the treatment was at least 4 weeks prior to initiation of study drug and brain MRI within 2 weeks of initiation of study drug is negative for new metastases.
• •Patients with pulmonary metastases
• •History of thoracic radiation or other history likely to create pre-existing lung disease
• •Ability to become pregnant (or already pregnant or lactating). However, those female patients who have a negative serum or urine pregnancy test before enrolment and agree to use two highly effective forms of contraception (oral, injected or implanted hormonal contraception and condom, have a intra-uterine device and condom, diaphragm with spermicidal gel and condom) for four weeks before entering the trial, during the trial and for six months afterwards are considered eligible..
• •Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using one form of highly effective contraception \[condom plus spermicide\] during the trial and for six months afterwards). Men with pregnant or lactating partners should be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure to the foetus or neonate.
• •Major thoracic or abdominal surgery from which the patient has not yet recovered.
• •Patients with sub-acute bowel obstruction
• •Patients using heparin, or warfarin/coumadin type anticoagulants, however, low-dose (\<2mg) coumadin for portacath patency is allowed;
• •Organ transplant recipients
• •Patients with known systemic disease with pulmonary involvement, including active uncontrolled infection.
• •Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
• •Patients with history of QT prolongation, clinically significant VT, VF, heart block, MI within 1 year, CHF NYHA Class III or IV, unstable angina, angina within 6 months, or other evidence of clinically significant coronary artery disease
• •Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this Phase I study of ONX-0801. Participation in an observational trial would be acceptable.
• •Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.