Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bristol-Myers Squibb
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed written informed consent
Available for protocol-required follow-up
ECOG performance status score 0 - 1 (See Appendix 1)
Histologic or cytologic diagnosis of a primary solid (i.e., non-hematologic) malignancy
Evidence (radiographic or tissue confirmation) that the disease is metastatic
Metastatic disease which has progressed on or following currently available standard therapies or for which no standard therapy exists. (Prior adjuvant or neoadjuvant therapy is permitted. Prior investigational agents are permitted);
Measurable or non-measurable disease as defined in Section 3.3.2.1
Adequate bone marrow function defined as:
absolute neutrophil count (neutrophil and bands) \>=2,000 cells/mm3
platelet count \>=125,000 cells/mm3
hemoglobin \>=9.0 g/dl
Adequate hepatic function defined as:
total bilirubin \<=1.5 times the institutional upper limit of normal,
alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<=2.0 times the institutional upper limit of normal
Adequate renal function defined as:
serum creatinine \<=1.5 times the institutional upper normal limit
Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the lower limit of normal. Patients with low potassium and magnesium levels may be repleted to allow for protocol entry.
CD4+ T-cell counts of \>=the institutional lower limit of normal.
Prior chemo-, radio-, hormonal or immunotherapy are allowed. Patients must have recovered from toxicity due to prior therapy i.e., toxicity has resolved to baseline or is deemed irreversible. At least 4 weeks must have elapsed since the last chemotherapy (6 weeks for nitrosoureas, mitomycin-C, and liposomal doxorubicin), immunotherapy or radiotherapy and the beginning of protocol therapy. At least 2 weeks must have elapsed since last hormonal therapy or exposure to any other "targeted" kinase inhibitor (e.g., imatinib mesylate).
Bleeding time \<=upper limit of institutional normal or platelet aggregometry result within the institutional normal limits
Men and women, ages 18 and older. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month prior and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.
WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal \[defined as amenorrhea \>=12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level \>35 mIU/mL\]. Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.
WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.
Heart rate \< 50 / minute on pre-entry electrocardiogram
Uncontrolled hypertension.
Dementia or altered mental status that would prohibit the understanding or rendering of informed consent;
History of significant bleeding disorder including:
Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
Documented major bleeding episode from the GI tract within 6 months unless no longer at significant risk due to surgical intervention
Vasculitis.
Received investigational agents within 4 weeks prior to the start of protocol therapy.
Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes including:
Class IA antiarrhythmic agents (quinidine, procainamide, disopyramide, mexiletine)
Class III antiarrhythmic agents ( amiodarone, sotalol, ibutilide, dofetilide)
Miscellaneous (cisapride, bepridil, inapsine, methadone, arsenic). Patients who have discontinued any of these medications must have a wash-out period of at least 5 days or at least 5 half-lives of the drug (whichever is greater) prior to the first dose of BMS-354825.
Patients taking medications that inhibit platelet function (e.g., aspirin, dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab, ticlopidine, and any non-steroidal anti-inflammatory drug) or anticoagulants (warfarin, heparin/low molecular weight heparin \[e.g., danaparoid, dalteparin, tinzaparin, enoxaparin\]). Patients who have discontinued aspirin must have a wash-out period of at least 7 days for low-dose aspirin (\<=325 mg/day) or 14 days for higher-dose aspirin (\> 325 mg/day) prior to the first dose of BMS-354825. Patients who have discontinued other antiplatelet or anticoagulant medications must have a wash-out period of at least 5 days or at least 5 half lives of the drug (whichever is greater) prior to the first dose of BMS-354825.
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.
You may not be if
WOCBP who are unwilling or unable to use an acceptable method 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.
WOCBP using a prohibited contraceptive method.
Women who are pregnant or breastfeeding.
Women with a positive pregnancy test on enrollment or prior to study drug administration.
Men who are unwilling or unable to use an acceptable method 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.
Received extensive prior radiation therapy to the bone marrow. Generally, patients should have radiation to \<=25% of bone marrow-containing skeleton (see Appendix 2).
A serious uncontrolled medical disorder or active infection which would impair the ability of the patient to receive protocol therapy.
Uncontrolled or significant cardiovascular disease, including:
A myocardial infarction within 12 months
Uncontrolled angina within 6 months
Congestive heart failure within 6 months
Diagnosed or suspected congenital long QT syndrome
Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsade de pointes). Any patient with a history of any arrhythmia should be discussed with the BMS Medical Monitor prior to entry into the study.
Prolonged QTc interval on pre-entry electrocardiogram (\> 450 msec)
