SB939 in Treating Patients With Recurrent or Metastatic Prostate Cancer

NCT01075308 | Completed Phase 2 DMC

• 3 other identifiers: I195CAN-NCIC-IND195CDR0000666241
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Prostate Cancer

Keywords

hormone-resistant prostate cancer; recurrent prostate cancer; stage IV prostate cancer; stage III prostate cancer; adenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (2)

• PSA response

  Each patient will have PSA response calculated. Required at the end of every cycle.

  each cycle

• Progression-free survival

  Used as an indicator of efficacy, patients with PSA response will have length of progression free survival calculated.

  end of study

Secondary Outcomes (6)

• Objective response rate

  every other cycle

• Duration of response

  every other cycle

• Safety

  each cycle

• Change in circulating tumor cells during study compared to baseline

  each cycle

• Comparison of TMPRSS2-ERG fusion and PTEN deletion in circulating tumor cells

  each cycle

Study Arms (1)

SB939

EXPERIMENTAL

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).

Drug: HDAC inhibitor SB939

Interventions

HDAC inhibitor SB939 DRUG

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).

SB939

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead
• S*BIO: collaborator

Study Sites (7)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BCCA - Cancer Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

QEII Health Sciences Center

Halifax, Nova Scotia, B3H 1V7, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (3)

• Eigl 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

  RESULT

• Eigl 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.

  RESULT

• Eigl 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 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

SB939 compound

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Kim N. Chi, MD

  British Columbia Cancer Agency

  STUDY CHAIR

• Bernhard Eigl, MD, FRCPC

  Tom Baker Cancer Centre - Calgary

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 25, 2010
• Study Start: June 28, 2010
• Primary Completion: January 5, 2015
• Study Completion: February 13, 2015
• Last Updated: August 4, 2023

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)