| Exclusion Criteria: | 1) WOCBP who are unwilling or unable to use an acceptable method (i.e. barrier, or spermicidal) to avoid pregnancy for the entire study period including the period from one month prior to starting study medication and for a period of at least 3 months after the study.
2) Women who are pregnant or breastfeeding.
3) Women with a positive pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) on enrollment or prior to study drug administration.
4) Men who are unwilling or unable to use an acceptable method (i.e. barrier, or spermicidal) of birth control for the entire study period and for at least 3 months after completion of study medication if their sexual partners are WOCBP.
5) Received extensive prior radiation therapy to the bone marrow. Generally, patients should have radiation to </= 25% of bone marrow-containing skeleton.
6) Symptomatic brain metastases that are either untreated or uncontrolled by surgery and or radiotherapy. Patients with symptoms of brain metastasis are not eligible unless brain metastasis are ruled out by CT or MRI and/or fully treated surgically or with WBRT.
7) A serious uncontrolled medical disorder or active infection which would impair the ability of the patient to receive protocol therapy.
8) Uncontrolled or significant cardiovascular disease, including: a) A myocardial infarction within 6 months b) Uncontrolled angina within 3 months c) Congestive heart failure within 3 months defined as NYHC-II d) Diagnosed or suspected congenital long QT syndrome
9) continued from 8: e) Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW) syndrome, or torsade de pointes). Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec). If the automated reading is prolonged (i.e., > 450 msec), the ECG should be manually overread. f) Any history of second or third degree heart block (may be eligible if currently have a pacemaker) g) Heart rate < 50 / minute on pre-entry electrocardiogram h) Uncontrolled hypertension (blood pressure >140 sys. and >90 dia.)
10) Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
11) Patients who have not recovered from adverse events greater than grade 1 due to agents administered more than 4 weeks earlier.
12) Prior exposure to PBI-05204
13) Subjects taking these medications: digoxin/digitoxin, verapamil, amiodarone, propafenone, indomethacin, itraconazole, alprazolam, sotalol, and quinidine. Subjects taking non-potassium sparing diuretics (with the exception of lasix or furosemide) or other investigational drugs.
14) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
15) Because patients with immune deficiency are at increased risk of lethal infections when treated with myelosuppressive therapy, patients known to have tested HIV-positive are excluded from the study.
16) Social situations that would limit compliance with study requirements.
17) History of allergic reactions attributed to compounds of similar chemical or biologic composition to PBI-05204, or other agents used in this study |