Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Celgene
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
histologically confirmed advanced solid tumors
measurable or evaluable disease
written informed consent
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Concomitant use of drugs that may cause a prolongation of the QTc
Concomitant use of CYP3A4 inhibitors
Clinically significant active infection
Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
Inadequate bone marrow or other organ function as evidenced by:
* Hemoglobin \<9 g/dL (Transfusions and/or erythropoietin are permitted.)
* Absolute neutrophil count (ANC) ≤1.5 x 10\^9 cells/L
* Platelet count \<100 x 10\^9 cells/L or platelet count \<75 x 10\^9 cells/L if bone marrow disease involvement is documented
* Total bilirubin \>2.0 x upper limit of normal (ULN)
* Aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) \>2.0 x ULN or \>3.0 x ULN in the presence of demonstrable liver metastases
* Serum creatinine \>2.0 x ULN
Patients who are pregnant or breast-feeding
Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures
You may not be if
Prior treatment with romidepsin or gemcitabine
Prior chemotherapy treatment within 3 weeks prior to the first day of treatment or prior treatment with an investigational agent within 4 weeks prior to the first day of treatment. Patients must have recovered from all therapy-related toxicities (Common Terminology Criteria grade ≤ 1)
Prior radiotherapy within 4 weeks prior to the first day of treatment. Patients who have not fully recovered or whose acute toxicity related to prior radiotherapy has not returned to baseline are ineligible.
Prior surgery within 3 weeks prior to the first day of treatment, excluding surgical biopsies and port placements
Concomitant use of any other anti-cancer therapy
Concomitant use of any investigational agent
Use of any investigational agent within 4 weeks of study entry
Any known cardiac abnormalities, including congenital long QT syndrome, QTcF interval \>480 milliseconds, myocardial infarction within 12 months of study entry, coronary artery disease (CAD), congestive heart failure (CHF), evidence of cardiac ischemia at screening, known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest, hypertrophic cardiomegaly or restrictive cardiomyopathy chronic hypertension, any cardiac arrhythmia requiring anti-arrhythmic medication
