SB939 in Treating Patients With Recurrent or Metastatic Prostate Cancer

• Status: Completed
• Trial end date: 2015-02-13
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: SB939 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well SB939 works in treating patients with recurrent or metastatic prostate cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Collaborator: S*BIO
• Treatments: Histone Deacetylase Inhibitors

Criteria

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