Codex: Study of Inodiftagene Vixteplasmid (BC-819) in Unresponsive NMIBC
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|ClinicalTrials.gov Identifier: NCT03719300|
Recruitment Status : Active, not recruiting
First Posted : October 25, 2018
Last Update Posted : November 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-muscle Invasive Bladder Cancer (NMIBC)||Drug: inodiftagene vixteplasmid||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of BC-819 in Patients With Non-Muscle Invasive Bladder Cancer Whose Disease is Unresponsive to Bacillus Calmette-Guerin|
|Actual Study Start Date :||December 11, 2018|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
Experimental: Single Arm BC-819
Drug: inodiftagene vixteplasmid
BC-819 at 20 mg/50 mL, instilled intravesically into the bladder, with a retention time of at least 30 minutes (up to 2 hours).
Induction Phase (weekly treatments): 10 weekly treatments; Maintenance Phase: treatment every 3 weeks for up to 84 additional weeks
Other Name: BC-819
- Complete response rate [ Time Frame: 12-48 weeks ]Complete response rate anytime on or after 12 weeks and within the first 48 weeks in patients with carcinoma in situ (CIS)
- High-grade recurrence free survival [ Time Frame: 48 weeks ]The incidence of Event Free Survival (EFS) at 48 weeks in all patients, where EFS is defined as high-grade recurrence free survival
- High-grade recurrence free survival [ Time Frame: 12, 24, 36, 72, and 96 weeks ]The incidence of EFS at 12, 24, 36, 72, and 96 weeks, where EFS is defined as high-grade recurrence free survival (overall population and subgroup of patients with CIS)
- Time to recurrence [ Time Frame: 12, 24, 36, 72, and 96 weeks ]Time to recurrence; recurrence is defined as an EFS event
- Progression-free survival [ Time Frame: 48, 72, and 96 weeks ]The incidence of progression-free survival at 48, 72, and 96 weeks as well as time to progression estimated using Kaplan-Meir methods.
- Overall survival of patients [ Time Frame: 48, 72, and 96 weeks ]Overall survival of patients enrolled in the study at 48, 72, and 96 weeks and survival time estimated using Kaplan-Meier methods
- Changes in quality of life (EORTC QLQ-C30) over time [ Time Frame: 48, 72, and 96 weeks ]Changes in quality of life over time, as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30; a general questionnaire for cancer) The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status/QoL scale and six single items. All scales range in score from 0 to 100. A high scale score represents a higher response level.
- Changes in quality of life (QLQ-NMIBC24) over time [ Time Frame: 48, 72, and 96 weeks ]Changes in quality of life over time, as measured by Non-Muscle Invasive Bladder Cancer Questionnaire (QLQ-NMIBC24; a specific questionnaire for NMIBC disease) The questionnaire assesses urinary symptoms, bowel symptoms, and sexual functioning as well as side effects of intravesical treatment (fever, malaise, etc).
- Duration of complete response rate [ Time Frame: 12-48 weeks ]Duration of complete response in patients with CIS.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719300
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