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Antisense Oligonucleotide
OGX-427 for Bladder Cancer
Phase 1
Waitlist Available
Led By Alan I So, MD, FRCSC
Research Sponsored by Vancouver Coastal Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient age must be > 18
No intravesical therapies within the previous 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Study Summary
This trial is a phase I dose escalation trial using a modified accelerated titration design to study the effects of OGX-427 on patients with superficial bladder tumours or CIS.
Who is the study for?
This trial is for adults over 18 with superficial bladder cancer (Ta or T1) or muscle invasive disease (>T2), who haven't had intravesical therapies in the last 6 months. Participants need to have no metastatic disease, meet certain blood and liver function criteria, and be able to complete questionnaires in English or French. Pregnant women, those not available for follow-up, on anticoagulation therapy like warfarin, with active infections or immune issues are excluded.Check my eligibility
What is being tested?
The study tests OGX-427 given before surgery—either transurethral resection for superficial tumours or radical cystectomy for muscle invasive ones. The drug's dose will increase until an optimal phase II dose is found based on side effects and its effect on Hsp27 protein levels in tumour tissues.See study design
What are the potential side effects?
Side effects of OGX-427 will be monitored including any adverse reactions as per NCI CTCAEv3.0 standards. Specific side effects aren't listed but could include typical chemotherapy-related symptoms such as fatigue, nausea, allergic reactions, and potential impact on blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
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I haven't had bladder treatments in the last 6 months.
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I am eligible for major bladder surgery and my initial tissue samples are available.
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My tests show no signs of cancer spread.
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I can take care of myself and am up and about more than half of my waking hours.
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My bladder cancer diagnosis was confirmed through tissue examination.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To define the dose-limiting toxicities (DLTs) of OGX-427 administered as an intravesical instillation.
To define the maximum tolerated dose (MTD) of OGX-427 administered as an intravesical instillation.
Secondary outcome measures
To determine the bladder PK and PD profile of OGX-427 after intravesical administration.
To determine the toxicity profile of OGX-427 when administered intravesically.
To measure evidence of OGX-427 effect on expression of Hsp27.
Find a Location
Who is running the clinical trial?
Vancouver Coastal HealthLead Sponsor
37 Previous Clinical Trials
711,876 Total Patients Enrolled
NCIC Clinical Trials GroupNETWORK
189 Previous Clinical Trials
144,805 Total Patients Enrolled
Vancouver General Hospital FoundationUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 18 years.I am on warfarin or Coumadin, or I have a bleeding disorder.I haven't had bladder treatments in the last 6 months.I do not have an active infection, including UTIs or tuberculosis, and my immune system is not impaired.I cannot have certain anesthesia due to health risks.I have had recent urethral trauma or cannot safely undergo catheterization or cystoscopy.I had a T1 bladder tumor removed and the tissue is available for study.I am eligible for major bladder surgery and my initial tissue samples are available.My tests show no signs of cancer spread.I can take care of myself and am up and about more than half of my waking hours.You cannot participate if your biopsy or cytology results are "indeterminate" or "negative."My bladder cancer diagnosis was confirmed through tissue examination.I can complete questionnaires in English or French.I have recurrent superficial bladder cancer and my tissue samples are available for study.Your recent lab tests show normal levels of white blood cells, platelets, liver enzymes, and kidney function.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How reliable is this intervention in terms of patient safety?
"Limited data on efficacy and safety gives this treatment a score of 1, denoting that it is currently in the first phase of evaluation."
Answered by AI
Is the recruitment period of this study still open?
"Clinicaltrials.gov states that this particular clinical trial, which was posted on July 1st 2009 and last updated on February 10th 2012 is not looking for new participants currently. Nevertheless, 373 other studies are open to enrolment."
Answered by AI
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