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Prostate CancerPhase 2NCT01075308

SB939 in Treating Patients With Recurrent or Metastatic Prostate Cancer

A Phase 2 study testing HDAC inhibitor SB939 in people with Prostate Cancer, run by NCIC Clinical Trials Group at 7 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
HDAC inhibitor SB939
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
7 sitesCanada
Study dates
28 Jun 2010to 13 Feb 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Canada7 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • QEII Health Sciences Center

    Halifax, Nova Scotia, B3H 1V7

  • BCCA - Cancer Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: A Phase II Study of SB939 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer

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.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the efficacy, as measured by PSA response and progression-free survival, of HDAC inhibitor SB939 in patients with recurrent or metastatic castration-resistant prostate cancer.

Secondary

  • To determine the objective response and response duration in patients with measurable disease at baseline.
  • To determine the tolerability and toxicity of this drug in these patients.
  • To determine the number of circulating tumor cells at baseline and after 6 weeks (and 12 weeks if patient is still on study treatment).
  • To explore potential molecular factors predictive of response by assessment of archival prostate tumor tissue.
  • To explore ERG and PTEN expression on circulating tumor cells as a potential prognostic and predictive marker for response to this drug.
  • To determine time to PSA and time to objective progression in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral HDAC Inhibitor SB939 once daily on days 1, 3, 5, 8, 10, 12, 15, 17, and 19. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Blood samples are collected periodically for correlative studies. Blood samples and Archival tumor tissue are analyzed for TMPRSS2-ERG fusion and PTEN deletion status by FISH; TMPRSS2-ERG fusion by RT-PCR; and for the number of circulating tumor cells.

After completion of study therapy, patients are followed up at 4 weeks and then every 3 months thereafter.

Conditions
Prostate Cancer
Being tested
HDAC inhibitor SB939
Keywords
hormone-resistant prostate cancer, recurrent prostate cancer, stage IV prostate cancer, stage III prostate cancer, adenocarcinoma of the prostate
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HDAC inhibitor SB939Drug

    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).

Study groups in NCT01075308
Study groupRoleWhat they receive
SB939ExperimentalSB939 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).
Receives: Drug: HDAC inhibitor SB939

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PSA response

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

    Measured: each cycle

  2. Progression-free survival

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

    Measured: end of study

Secondary outcomes (6)

  1. Objective response rate

    Patients with measurable disease will have objective response evaluated.

    Measured: every other cycle

  2. Duration of response

    Patients with objective response will have duration of response calculated as will be followed until progression/relapse

    Measured: every other cycle

  3. Safety

    Toxicity and tolerability will be evaluated

    Measured: each cycle

  4. Change in circulating tumor cells during study compared to baseline

    Patients will have on study samples compared to baseline to look for chance in number of CTC.

    Measured: each cycle

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

    samples will be taken and analyzed each cycle with a comparison made at end of study.

    Measured: each cycle

  6. Comparison of two systems for counting circulating tumor cells

    Two different systems will be used to count CTC. Results will be compared at the end of the study for accuracy.

    Measured: end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2010 (estimated)
  2. Study start28 Jun 2010
  3. Primary completion5 Jan 2015
  4. Study completion13 Feb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01075308
Sponsor's protocol ID
I195
Other IDs
CAN-NCIC-IND195, CDR0000666241
Status last verified
Apr 2020
First submitted
24 Feb 2010
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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.

  • 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.

    PubMed 25983041

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HDAC inhibitor SB939 in people with Prostate Cancer, run by NCIC Clinical Trials Group at 7 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PSA response (time frame: each cycle). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01075308, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.

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