An exploratory Phase II, multicenter, open-label trial evaluating the activity and tolerability of of FK228 in androgen independent metastatic prostate cancer patients with a rising PSA. - Depsipeptide in prostate cancer
- Conditions
- Metastatic prostate cancerMedDRA version: 5.0 Level: CTEP Classification code 10036920
- Registration Number
- EUCTR2005-001576-13-GB
- Lead Sponsor
- Gloucester Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 76
Males aged >/=18 years;
Histologically or cytologically confirmed metastatic prostate cancer with documented prpgression on hormonal therapy (objective progressive disease [PD], new bone lesions, or stable soft tissue or bone lesions with PSA increase);
Rising PSA, with a minimum study entry PSA of >/=5 ng/mL;
Karnofsky performance status of >/=80%;
Life expectancy of >/=12 weeks;
For patients treated with anti-androgens, elevation of PSA must be demonstrated after cessation of anti-androgen treatment;
Three lines of hormonal therapy are permitted prior to study entry (anti-androgen withdrawal is not considered as a second hormonal treatment); and
Serum testosterone level of <50 ng/mL in patients without surgical castration
Written informed consent to participate in the study.
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
•Concomitant use of any anti-cancer therapy, except for continued use of luteinizing hormone-releasing hormone (LHRH) agonists or antiandrogens, or bisphosphonates or steroids initiated at least 4 weeks prior to study entry;
•Concomitant use of any investigational agent, including PC-SPES;
•Use of any investigational agent within 4 weeks of study entry;
•Major surgery within 2 weeks of study entry;
•Prior treatment with chemotherapy;
•Patients with known cardiac abnormalities such as:
Congenital long QT syndrome
Corrected QT (QTc) interval >480 milliseconds
•Patients who have had a myocardial infarction within 12 months of study entry;
•Patients who have a history of coronary artery disease (CAD) e.g., angina Canadian Class II-IV . 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 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 NYHA Class II to IV definitions and/or ejection fraction <40% by multiple-gated acquisition (MUGA) scan or <50% by echocardiogram and/or magnetic resonance imaging (MRI)
•Patients with a history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD);
•Patients with hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes (in doubt, see ejection fraction criteria above)
•Patients with uncontrolled hypertension i.e., =160/95
•Patients with any cardiac arrhythmia requiring anti-arrhythmic medication
•Concomitant use of medications which may cause a prolongation of QT/QTc interval;
•Concomitant use of medications that are inhibitors of the cytochrome P-450 isoenzyme CYP 3A4
•Concomitant use of drugs which may cause a prolongation of the QTc
•Clinically significant active infection;
•Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C;
•Previous extensive radiotherapy involving >30% of bone marrow (e.g., whole of pelvis, half of spine);
•Clinical or radiological imaging evidence of brain metastasis (computed tomography [CT] or magnetic resonance imaging [MRI] scans are required only if brain metastasis is suspected clinically);
•Inadequate bone marrow or other organ function
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method