Trial Outcomes & Findings for 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 (NCT NCT01310803)

Last Updated: 2017-10-05

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

1 participants

Primary outcome timeframe

2 years

Results posted on

2017-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	Maintenance Therapy Chemotherapeutic: EN3329-301 (VALSTAR) VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase	No Maintenance (Standard of Care) Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Maintenance Therapy Chemotherapeutic: EN3329-301 (VALSTAR) VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase	No Maintenance (Standard of Care) Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy
Overall Study Subject terminated by Sponsor	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Maintenance Therapy n=1 Participants Chemotherapeutic: EN3329-301 (VALSTAR) VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase	No Maintenance (Standard of Care) Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	—	1 Participants n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	—	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=93 Participants	—	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) White	1 Participants n=93 Participants	—	1 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	—	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: 2 years

Population: No analysis completed due to limited enrollment (1 subject) prior to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: No analysis completed due to limited enrollment (1 subject) prior to study termination.

The occurrence of serious adverse events (SAEs), occurrence of local adverse reactions (LARs), results of vital signs, physical exams and laboratory test, and study discontinuation due to inability to complete valrubicin instillations

Outcome measures

Outcome data not reported

Adverse Events

Maintenance Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Maintenance (Standard of Care)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Trial Coordinator

Endo Pharmaceuticals, Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Institution and/or Principal Investigator shall not publish or present information related to the Study without prior written permission of Sponsor. Sponsor may withhold permission if a publication or presentation is in violation of other agreements, is not consistent with academic standards, is false or misleading, or is for commercial purposes.
Publication restrictions are in place

Restriction type: OTHER