Clinical trial · Interventional
SB939 in Treating Patients With Recurrent or Metastatic Prostate Cancer
A Phase II Study of SB939 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
NCT01075308CI-TRIAL-00068538completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HDAC inhibitor SB939 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SB939
- description
- SB939 given orally every other day 3 times a week (i.e. Monday /Wednesday /Friday, or Tuesday /Thursday / Saturday) for 3 consecutive weeks followed by one week off-dosing. A treatment cycle is 4 weeks (28 days).
- interventionNames
- Drug: HDAC inhibitor SB939
Primary outcomes (2)
- measure
- PSA response
- timeFrame
- each cycle
- description
- Each patient will have PSA response calculated. Required at the end of every cycle.
- measure
- Progression-free survival
- timeFrame
- end of study
- description
- Used as an indicator of efficacy, patients with PSA response will have length of progression free survival calculated.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 therapyReferences
Publications (3)
- RESULTEigl BJ, North S, Murray N, Heng DYC, Winquist E, Powers J, Walsh WR, Eisenhauer E, Squire J, Cox M, Chi KN. A Phase II Study of SB939 in Patients with Recurrent or Metastatic Castration Resistant Prostate Cancer (CRPC). AACR Mol Cancer Tehr 10[11 Suppl; abstr A211]. 2011
- RESULTEigl BJ, North S, Murray N, Heng DYC, Winquist E, Powers J, Walsh WR, Eisenhauer E, Squire J, Cox M, Chi KN. A Phase II Study of SB939 in Patients with Recurrent or Metastatic Castration Resistant Prostate Cancer (CRPC). Canadian Cacner Research Conference. 2011.
- RESULTEigl BJ, North S, Winquist E, Finch D, Wood L, Sridhar SS, Powers J, Good J, Sharma M, Squire JA, Bazov J, Jamaspishvili T, Cox ME, Bradbury PA, Eisenhauer EA, Chi KN. A phase II study of the HDAC inhibitor SB939 in patients with castration resistant prostate cancer: NCIC clinical trials group study IND195. Invest New Drugs. 2015 Aug;33(4):969-76. doi: 10.1007/s10637-015-0252-4. Epub 2015 May 19. PMID 25983041