AzTrials
AzTrials

Bladder CancerPhase 1NCT00959868

A Study for Treatment of Superficial Bladder Cancer Using OGX-427

A Phase 1 study testing OGX-427 in people with Bladder Cancer, run by Vancouver Coastal Health at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a single centre, open label, phase I dose escalation trial using a modified accelerated titration design. Patients with superficial bladder tumour (Ta or T1) or CIS and candidates for transurethral resection or muscle invasive disease (>T2) and candidates for radical cystectomy will be enrolled. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
OGX-427
Type of treatment
Injection or infusion
How many people
36 participants
Where
1 siteCanada
Study dates
Jul 2009to Dec 2012
Phase
Phase 1
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient age must be > 18
  • Histologic evidence of bladder cancer (superficial or muscle invasive) or
  • CIS as evidenced by:
  • Patients presenting with superficial tumours and unknown pathological stage will have in-clinic bladder washings (performed cystoscopically) and biopsy (cup biopsy).
  • Patients with recurrent superficial disease (Ta or T1) and tissue that is available for baseline studies (i.e. tissue from previous transurethral resection stored in paraffin blocks) will be eligible for trial without requiring cytology or biopsy.
  • Patients with previously diagnosed T1 tumours and requiring re-resection of bladder tumour will be eligible if tissue from the original TURBT is available for baseline studies.
Show all 17Show fewer
  • Patients presenting as muscle invasive (>T2) disease will be eligible if they are candidates for radical cystectomy and if baseline tissue from initial resections is available for baseline studies
  • No intravesical therapies within the previous 6 months
  • No evidence of metastatic disease as determined by physical exam, CT scan or chest- x-ray, where indicated.
  • ECOG status must be 0, 1, or 2
  • Laboratory requirements (within 7 days of treatment):
  • negative urine cultures
  • Absolute neutrophils count> 1.5 x 109 cells/L, and platelets count> 100 x 109/L,
  • Total bilirubin < 1.5 x upper normal limit (ULN), AST and/or ALT < 1.5 x ULN, alkaline phosphatase < 1.5 x ULN, and serum creatinine < 1.5 x ULN.
  • PTT and INR, within normal limits
  • Patient must be able to complete the quality of life questionnaires in either English or French
  • Patients must provide written informed consent.

Who cannot join

  • Patients with "indeterminate" or "negative" results from biopsy or cytology will be ineligible for the trial.
  • Patients taking warfarin or Coumadin anticoagulation therapy or who have a bleeding disorder. NOTE: Patients who require anticoagulation therapy while on study will be removed from study treatment.
  • Pregnant or lactating women
  • Patients not accessible for follow-up
  • Patients with an active urinary tract infection, upper tract urothelial tumors, active infection including tuberculosis, concurrent febrile illness or impaired immune response from any cause
  • Patients with contraindication to spinal or general anesthesia required for a transurethral resection or radical cystectomy
  • Recent (<14 days) urethral trauma or inability to perform catheterization or cystoscopy safely
  • Patients known to have a serious illness or medical condition that would impair protocol treatment delivery.

Trial locations and contacts

1 site in 1 country.

Maureen Palmer, RN contact

604-875-5675

Maureen.Palmer@vch.ca

Canada1 site, 1 recruiting

  • The Prostate Centre at Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

    Maureen Palmer, RN, 604-875-5675, Maureen.Palmer@vch.ca

    Alan I So, MD, FRCSC

    Recruiting

Other trials in Canada

About this study

Official title: A Phase I Clinical Trial Assessing Intravesical Antisense Oligonucleotide Targeting Heat Shock Protein 27 for the Treatment of Superficial Bladder Cancer

This is a single centre, open label, phase I dose escalation trial using a modified accelerated titration design. Patients with superficial bladder tumour (Ta or T1) or CIS and candidates for transurethral resection or muscle invasive disease (>T2) and candidates for radical cystectomy will be enrolled.

OGX-427 will be given neoadjuvantly over 8 days, followed by a transurethral resection (for superficial disease) or radical cystectomy (for muscle invasive disease).

Read more

Baseline Hsp27 levels will be determined from pre-treatment cytological samples from bladder washings and tumour biopsies performed prior to therapy.

Post-treatment PK and PD data will be determined from TUR (for Ta, T1 tumours) or radical cystectomy (for T2 tumours) specimens. A recommended phase II dose will be determined from the toxicity, tissue pK, and percentage of Hsp27 knockdown. Effects of treatment on Hsp27 client protein levels and apoptotic index will also be evaluated.

Evaluation during protocol treatment will take place to assess toxicity. Assessments will occur on various visits as per Evaluation Schedule. Adverse event evaluation based on NCI CTCAEv3.0. For quality of life assessment during treatment, the EORTC QLC-BLS24 will be used before first treatment (day 1) and prior to surgery (TURBT or radical cystectomy). The Day 1 QOL assessment will serve as baseline.

After removal from protocol treatment, all subjects will be followed for toxicity related to study drug for 30 days.

After the study, subjects will be followed according to standard of care. Follow-up for tumour recurrence or superficial tumours will be assessed every three months by cystoscopic examination for two years, then every six months for the next two years, and then yearly thereafter.

Conditions
Bladder Cancer
Being tested
OGX-427
Keywords
Bladder cancer, Superficial bladder cancer (Ta or T1), Muscle invasive bladder cancer (T2), Transurethral resection, Radical cystectomy, OGX-427, Antisense oligonucleotide, Heat shock protein 27, superficial bladder tumour (Ta or T1) or CIS prior to a transurethral resection, Muscle invasive (T2) bladder cancer prior to radical cystectomy
Medical subject headings
Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms, Neuronopathy, Distal Hereditary Motor, Type IIB

What participants receive

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

  • OGX-427Drug

    OGX-427 drug product is in 25mg/mL injection in a mannitol-phosphate buffer solution packaged to deliver at least 8mL volume from a 10mL Type I, clear glass vial (ammonium sulfate treated) with Teflon coated bromobutyl rubber stopper and sealed with an aluminum, red, flip-off over seal. The drug product is aseptically compounded and sterilized via sterile filtration prior to aseptic filling.

What is being measured

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

  1. To define the maximum tolerated dose (MTD) of OGX-427 administered as an intravesical instillation.

    The study medication will be escalated according to a fixed dose escalation plan. Three subjects will be treated per cohort. If one of the three subjects experiences a DLT, three additional subjects will be treated at that dose level (i.e. maximum of 6 subjects per cohort)

    Measured: One year

  2. To define the dose-limiting toxicities (DLTs) of OGX-427 administered as an intravesical instillation.

    The study medication will be escalated according to a fixed dose escalation plan. Three subjects will be treated per cohort. If one of the three subjects experiences a DLT, three additional subjects will be treated at that dose level(i.e. maximum of 6 subjects per cohort)

    Measured: one year

Secondary outcomes (3)

  1. To determine the toxicity profile of OGX-427 when administered intravesically.

    Measured: One year

  2. To measure evidence of OGX-427 effect on expression of Hsp27.

    Measured: one year

  3. To determine the bladder PK and PD profile of OGX-427 after intravesical administration.

    Measured: one year

Timeline

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

  1. First posted17 Aug 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionDec 2012 (estimated)

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00959868
Sponsor's protocol ID
BL-01
Status last verified
Feb 2012
First submitted
13 Aug 2009
Last updated
13 Feb 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OGX-427 in people with Bladder Cancer, run by Vancouver Coastal Health at 1 site in Canada.

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

Who may be eligible to take part?

The sponsor lists 17 inclusion and 8 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 13 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Maureen Palmer, RN (604-875-5675, Maureen.Palmer@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To define the maximum tolerated dose (MTD) of OGX-427 administered as an intravesical instillation. (time frame: One year). 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 NCT00959868.

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 13 Feb 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in