A Phase II Study of SB939 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
Treatment Plan
Arm/Group Label
Arm/Group Type
Arm/Group Description
Not Provided
Intervention(s)
HDAC inhibitor SB939,
Patient eligibility
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Presence of clinically and/or radiologically documented disease (target or
non-target)
- Metastatic or locally recurrent disease for which no curative therapy exists AND for
which systemic chemotherapy is indicated due to progression, meeting the following
criteria:
- At least two rises in PSA over a reference value OR the development of new
metastatic lesions with a stable or rising PSA
- First rising PSA must be taken at least 1 week after the reference value
- Third or subsequent PSA must show further increase confirming progression
within 2 weeks prior to study enrollment
- PSA progression must be documented after discontinuation of peripheral
antiandrogens (4 weeks for flutamide and 6 weeks for
bicalutamide/nilutamide) for patients with documented evidence of
progression while receiving peripheral antiandrogens
- Medically or surgically castrated by androgen ablation
- Castrate level of testosterone (< 1.7 nmol/L) must be present for patients
undergoing medical androgen ablation
- Received prior hormone therapy
- Must have hormone-refractory disease
- Therapy with luteinizing hormone-releasing hormone (LHRH) agonist must continue
for patients already receiving this treatment at the time of enrollment
- Patients who discontinued LHRH agonist must restart therapy (if not surgically
castrated) and the castrate level of testosterone must be present
- PSA >= 5 ng/mL
- Primary or metastatic tumor tissue available
- No documented CNS metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy >= 12 weeks
- Absolute granulocyte count >= 1.5 x 10^9/L
- Platelet count >= 100 x 10^9/L
- AST and ALT <= 2.5 times upper limit of normal (ULN)
- Bilirubin normal
- Serum creatinine normal
- Potassium normal
- Calcium normal
- Fertile patients must use effective contraception
- QTc <= 450 msec
- LVEF >= 50% by Echo or MUGA scan
- Troponin I or T <= ULN
- Able to take oral medication
- No preexisting uncontrolled cardiac condition
- No prior myocardial infarction
- No history of other malignancies, except adequately treated nonmelanoma skin cancer
or other solid tumors curatively treated with no evidence of disease for >= 5 years
- No gastrointestinal abnormalities (e.g., bowel obstruction or previous gastric
resection) that would lead to inadequate absorption of HDAC Inhibitor SB939
- No known HIV positivity or hepatitis B or C infections
- No chronic medical condition or comorbidity that may increase the risks associated
with study participation/study drug administration or may interfere with the
interpretation of study results, including any of the following:
- Pulmonary disease
- Active infection
- Psychiatric condition
- Laboratory abnormality
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks since prior antiandrogens (6 weeks for bicalutamide)
- At least 4 weeks since prior external-beam radiotherapy
- Exceptions may be made for low-dose, non-myelosuppressive radiotherapy
- At least 28 days since other prior investigational therapy or anticancer therapy
- At least 14 days since prior major surgery and wound healing has occurred
- No more than 1 prior chemotherapy regimen allowed and recovered from significant
toxicity
- No prior strontium
- No prior HDAC inhibitors
- No current agents (dysrhythmic drugs) with a known risk of Torsades de Pointes
- No other concurrent cytotoxic therapy or radiotherapy
- No other concurrent investigational therapy
For detailed patient eligibility criteria for this clinical trial, please click here to show/hide
