Metastatic prostate cancer MedDRA version: 5.0 Level: CTEP Classification code 10036920
Conditions
Sponsors
Gloucester Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to evaluate the activity of FK228 in patients with metastatic prostate cancer who have developed a rising PSA while undergoing hormonal therapy. Activity will be measured as the rate of disease control (complete response [CR], partial response [PR], or stable disease [SD] for at least 6 months). ; Secondary Objective: The secondary objectives of this trial are: • To evaluate the rate of PSA decline by >/=50%; • To evaluate the percentage of PSA decline; • To evaluate the time to PSA progression; • To evaluate the time to objective disease progression; • To assess the tolerability and safety of FK228; • To evaluate the effect of therapy on disease-related symptoms (Memorial Pain Scale); • To evaluate the effect of the therapy on performance status; and • To evaluate the pharmacokinetics of FK228. • To evaluate the duration of objective disease response ; Primary end point(s): • The rate of objective disease control, defined as the proportion of patients with confirmed CR, PR, or SD for at least 6 months, as determined by the Response Evaluation Criteria for Solid Tumors (RECIST) Secondary Endpoints • Rate of PSA decline by >/=50%; • Percentage of PSA decline; • Time to PSA progression; • Duration of objective disease response • Time to objective disease progression; • Rate of grade 3 and grade 4 non-hematological toxicity, adverse events, 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 modifi | — |
Countries
United Kingdom
Outcome results
None listed