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

NCT01310803 | Terminated Phase 3 Results

• 1 other identifier: EN3329-301
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 6

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).

Conditions

Carcinoma in Situ; Transitional Cell Carcinoma; Non-muscle Invasive Bladder Cancer

Keywords

Urinary Bladder Neoplasms; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urinary Bladder Diseases; Urologic Diseases; TURBT; Valstar

Outcome Measures

Primary Outcomes (1)

• 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 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).

  2 years

Secondary Outcomes (1)

• 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

Study Arms (2)

Maintenance therapy

EXPERIMENTAL

Chemotherapeutic: EN3329-301 (VALSTAR)

Drug: VALSTAR - Maintenance Therapy

No Maintenance (Standard of care)

OTHER

Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy

Other: No Maintenance treatment ( Standard of Care)

Interventions

VALSTAR - Maintenance Therapy DRUG

Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase

Also known as: VALSTAR

Maintenance therapy

No Maintenance treatment ( Standard of Care) OTHER

Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy

No Maintenance (Standard of care)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• Concurrent urinary tract infection
• Absolute neutrophil count (ANC) \<1000/µL and hemoglobin \<10 g/dL
• Have active cardiovascular disease such as myocardial infarction within the past 3 months, unstable angina pectoris, congestive heart failure (NYHA Class III or IV) or uncontrolled cardiac arrhythmia
• Female subjects who are pregnant or lactating
• Subjects of childbearing potential who are unwilling to practice abstinence or effective contraception (as defined by investigator) during the study and for 30 days after last dose of study treatment

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (6)

BCG Oncology

Phoenix, Arizona, 85032, United States

Location

The Urology Center of Colorado

Denver, Colorado, 80211, United States

Location

Urology Associates

Cumberland, Maryland, 21502, United States

Location

Delaware Valley Urology

Sewell, New Jersey, 08080, United States

Location

Associated Medical Professionals of New York

Syracuse, New York, 13210, United States

Location

Urologic Consultants of SE PA

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

MeSH Terms

Conditions

Carcinoma in Situ; Carcinoma, Transitional Cell; Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urinary Bladder Diseases; Urologic Diseases

Interventions

valrubicin; Standard of Care

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

This study was terminated early. Only one subject was enrolled. No study results were generated.

Results Point of Contact

• Title: Clinical Trial Coordinator
• Organization: Endo Pharmaceuticals, Inc.

clinicalsite.inquiries@endo.com

Study Officials

• Philippe E Spiess, MD, MS, FACS, FRCS(C)

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2011
• First Posted: March 9, 2011
• Study Start: May 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: October 5, 2017
• Results First Posted: October 22, 2014

Record last verified: 2017-09

Locations

US (6)