Brief Title
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
Official Title
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
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).
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
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.
Secondary Outcome
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
Condition
Carcinoma in Situ
Intervention
VALSTAR - Maintenance Therapy
Study Arms / Comparison Groups
Maintenance therapy
Description: Chemotherapeutic: EN3329-301 (VALSTAR)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
1
Start Date
May 2011
Completion Date
January 2012
Primary Completion Date
January 2012
Eligibility Criteria
Inclusion Criteria:
1. Is 18 years of age and older at time of consent signing
2. Have histologically confirmed diagnosis of CIS of the bladder and received valrubicin
induction therapy per the labeled indication.
3. 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
4. Is available for the duration of the study including follow-up (minimum 12 months from
randomization)
5. Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of 2 or
less
6. 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
7. 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
8. Is able to understand and give written informed consent
Exclusion Criteria:
1. Have current or previous history of muscle-invasive bladder cancer (MIBC)
2. Current or previous history of lymph node positive and/or metastatic bladder cancer
3. Have current evidence of pure squamous cell carcinoma, pure adenocarcinoma or pure
undifferentiated carcinoma of the bladder
4. Is currently receiving systemic anti-cancer therapy (cytotoxic/cytostatic,
immunotherapy or radiation)
5. Received treatment with an investigational agent within 30 days or 5 half-lives prior
to randomization, whichever is longer
6. 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
7. Received treatment with valrubicin other than induction within 3 months prior to
randomization
8. 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
9. Absolute neutrophil count (ANC) <1000/µL and hemoglobin <10 g/dL
10. 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
11. Female subjects who are pregnant or lactating
12. 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
13. Have current or history of documented or suspected malignancy of any organ system
(diagnosed, treated or untreated) within the past 5 years (with the exception of
adequately treated basal cell or squamous cell carcinoma of the skin and asymptomatic
non-metastatic prostate cancer either previously successfully treated or currently
under active surveillance or receiving hormone therapy only)
14. Is unable to tolerate intravesical administration or intravesical surgical
manipulation (cystoscopy or biopsy) even with premedication
15. Have ongoing clinically significant active infections
16. Have any medical or psychiatric condition which, in the opinion of the investigator,
would preclude the participant from adhering to the protocol or completing the trial
per protocol
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Philippe E Spiess, MD, MS, FACS, FRCS(C), ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01310803
Organization ID
EN3329-301
Responsible Party
Sponsor
Study Sponsor
Endo Pharmaceuticals
Study Sponsor
Philippe E Spiess, MD, MS, FACS, FRCS(C), Principal Investigator, H. Lee Moffitt Cancer Center and Research Institute
Verification Date
September 2017