Status:
COMPLETED
A Study of Romidepsin (Depsipeptide) in Combination With Gemcitabine in Patients With Pancreatic and Other Advanced Solid Tumors
Lead Sponsor:
Celgene
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This was a phase I dose escalation trial designed to determine the maximum tolerated dose (MTD) for the combination of romidepsin (depsipeptide) and gemcitabine. The study was originally planned as a ...
Eligibility Criteria
Inclusion
- histologically confirmed advanced solid tumors
- measurable or evaluable disease
- written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Exclusion
- 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
- Serum potassium \<3.8 mmol/L or serum magnesium \<2.0 mg/dL (electrolyte abnormalities can be corrected with supplementation to meet inclusion criteria)
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00379639
Start Date
July 1 2006
End Date
July 1 2008
Last Update
October 30 2019
Active Locations (1)
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1
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203