Refractory Prostate cancer MedDRA version: 5.0 Level: CTEP Classification code 10036920
Conditions
Sponsors
Gloucester Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent/authorization; • Patient has completed 6 cycles of therapy in a prior Gloucester-sponsored depsipeptide clinical trial; • Patient has immediate past participation (not to exceed 21 days from Day 15 of cycle 6 in the previous study) in a prior Gloucester-sponsored depsipeptide clinical trial; • Patient has demonstrated stable disease, partial response or complete response as best overall response in their prior Gloucester-sponsored depsipeptide clinical trial and such response must be ongoing at the time of enrollment; • Patient must have serum potassium levels >4.0 mEq/L and serum magnesium levels >2.0 mg/dL; • Negative urine or serum pregnancy test on females of childbearing potential; • Sexually active females of child-bearing potential must be willing to practice reliable methods of birth control to prevent pregnancy after entering the trial; • Sexually active males must be willing to practice reliable methods of birth control after entering the trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients with known cardiac abnormalities such as: • Congenital long QT syndrome ; • QTc interval >480 milliseconds; • Patients with any cardiac arrhythmia requiring anti-arrhythmic medication; • Patients who have a history of coronary artery disease (CAD) e.g., angina Canadian Class II-IV (see Appendix G). In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present; • Patients who have had a myocardial infarction within 12 months of study entry; • Patients with an ECG recorded at screening showing evidence of cardiac ischemia (ST depression of =2 mm). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present; • Patients with congestive heart failure that meets New York Heart Association (NYHA) Class II to IV definitions and/or ejection fraction 2 mg/dL or creatinine clearance 2.0 X ULN or >5 X ULN in presence of demonstrable liver metastasis; • Bilirubin concentration >1.25 X ULN or >2.0 X ULN in the presence of demonstrable liver metastases; • Serum potassium <4.0 mEq/L and serum magnesium <2.0 mg/dL; • Failure to recover of any drug-related non-hematological toxicity to grade 1 or less or to baseline values unless otherwise indicated; • Concomitant use of warfarin (due to a potential drug to drug interaction with depsipeptide). • Patient is pregnant or nursing; • Patient has been on a prior Gloucester-sponsored depsipeptide clinical trial, left the trial and then received alternative anti-neoplastic therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives of this trial are: • To evaluate the effect of depsipeptide therapy on performance status; • To evaluate the time to objective disease progression. ;Main Objective: The primary objective of this trial is to evaluate the safety and tolerability of extended treatment with depsipeptide in patients who have at least demonstrated stable disease on a prior Gloucester-sponsored depsipeptide clinical trial, and in the opinion of their physician/investigator might benefit from continued treatment with depsipeptide. ; Primary end point(s): • Time to objective disease progression; • Rate of grade 3 and grade 4 non-hematological toxicity, AEs, clinical laboratory data, rate of grade 4 hematological toxicity, rate of neutropenic fever/sepsis, number of blood transfusions, ECG findings, frequency of cycles and administrations delayed as result of toxicity, and the frequency of cycles and administrations requiring dose modification because of toxicity; and • Change in performance status. | — |
Countries
United Kingdom
Outcome results
None listed