A PHASE 3B, RANDOMIZED, OPEN-LABEL, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MAINTENANCE THERAPY WITH VALRUBICIN VERSUS NO MAINTENANCE, IN SUBJECTS TREATED WITH VALRUBICIN INDUCTION FOR CARCINOMA IN SITU (CIS) OF THE BLADDER
Overview
- Phase
- Phase 3
- Intervention
- VALSTAR - Maintenance Therapy
- Conditions
- Carcinoma in Situ
- Sponsor
- Endo Pharmaceuticals
- Enrollment
- 1
- Locations
- 6
- Primary Endpoint
- To Evaluate the Efficacy of Maintenance Therapy With Valrubicin After Induction With Valrubicin, as Compared to Induction With Valrubicin Only in Subjects With CIS of the Bladder.
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
This is a Phase 3b open-label, randomized, parallel-arm, multicenter study to evaluate the efficacy and safety of 10 monthly intravesical administrations of maintenance therapy with valrubicin following induction with valrubicin as compared to induction with valrubicin only in subjects with CIS of the bladder. The randomization will be 1:1 and subjects will be stratified by tumor type (CIS plus papillary disease vs. CIS only) and time from last bacillus Calmette-Guerin (BCG) failure (>1 year vs. <1 year).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Is 18 years of age and older at time of consent signing
- •Have histologically confirmed diagnosis of CIS of the bladder and received valrubicin induction therapy per the labeled indication.
- •Is disease-free following induction with intravesical valrubicin
- •Disease-free is defined as negative biopsy 10 to 12 weeks after the initiation of valrubicin induction
- •Valrubicin induction is defined as having received at least 3 of 6 weekly instillations
- •Is available for the duration of the study including follow-up (minimum 12 months from randomization)
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of 2 or less
- •Have no evidence of urothelial carcinoma involving the upper urinary tract or prostatic urethra (confirmed by extravesical work up, which may include radiological imaging and/or biopsy) within 6 months prior to randomization
- •Subjects (male and female) of child-bearing potential (including female subjects who are post-menopausal for less than 1 year) must be willing to practice abstinence or effective contraception (as defined by the investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment
- •Is able to understand and give written informed consent
Exclusion Criteria
- •Have current or previous history of muscle-invasive bladder cancer (MIBC)
- •Current or previous history of lymph node positive and/or metastatic bladder cancer
- •Have current evidence of pure squamous cell carcinoma, pure adenocarcinoma or pure undifferentiated carcinoma of the bladder
- •Is currently receiving systemic anti-cancer therapy (cytotoxic/cytostatic, immunotherapy or radiation)
- •Received treatment with an investigational agent within 30 days or 5 half-lives prior to randomization, whichever is longer
- •Received treatment with an intravesical chemotherapeutic agent (other than valrubicin or a single administration of mitomycin C post-transurethral resection of bladder tumor \[TURBT\]) within 3 months prior to randomization
- •Received treatment with valrubicin other than induction within 3 months prior to randomization
- •Have contraindication to valrubicin
- •Known hypersensitivity to anthracyclines or polyoxyl castor oil
- •Small bladder capacity, i.e. unable to tolerate a 75 mL instillation
Arms & Interventions
Maintenance therapy
Chemotherapeutic: EN3329-301 (VALSTAR)
Intervention: VALSTAR - Maintenance Therapy
No Maintenance (Standard of care)
Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy
Intervention: No Maintenance treatment ( Standard of Care)
Outcomes
Primary Outcomes
To Evaluate the Efficacy of Maintenance Therapy With Valrubicin After Induction With Valrubicin, as Compared to Induction With Valrubicin Only in Subjects With CIS of the Bladder.
Time Frame: 2 years
time interval from randomization to an event. An event is defined as tumor recurrence (any stage or grade), tumor progression to muscle-invasive bladder cancer (MIBC), metastatic bladder cancer or death from any cause, whichever occurs first. Tumor recurrence or progression must be documented by biopsy/transurethral resection of bladder tumor (TURBT).
Secondary Outcomes
- To Evaluate the Safety and Tolerability of Maintenance Therapy With Valrubicin After Induction With Valrubicin, as Compared to Induction With Valrubicin Only in Subjects With CIS of the Bladder(2 years)