Trial Outcomes & Findings for Phase 2b, Trial of Intravesical DTA-H19/PEI in Patients With Intermediate-Risk Superficial Bladder Cancer (NCT NCT00595088)

NCT ID: NCT00595088

Last Updated: 2019-04-30

Results Overview

Tumor response evaluated at week 9 (range 8-10 weeks) during the first post induction course treatment cystoscopy or TUR of suspiciaous lesions

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 47 participants
• Primary outcome timeframe: 9 Weeks
• Results posted on: 2019-04-30

Participant Flow

First patient first visit 12 Feb 2008, Last patient first visit 19 Sep 2012. All patients were recruited at the medical sites

Patients had to be H19 positive to be recruited

Participant milestones

Measure	20 mg of BC-819/PEI Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer \[recurrent stages Ta (low or high grade) and T1 (low grade) TCC\] who have failed prior intravesical therapies including BCG and/or chemotherapy.
Overall Study STARTED	47
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	40

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 2b, Trial of Intravesical DTA-H19/PEI in Patients With Intermediate-Risk Superficial Bladder Cancer

Baseline characteristics by cohort

Measure	20 mg of BC-819/PEI n=47 Participants Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer \[recurrent stages Ta (low or high grade) and T1 (low grade) TCC\] who have failed prior intravesical therapies including BCG and/or chemotherapy.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	31 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants
Region of Enrollment Israel	39 participants n=5 Participants

PRIMARY outcome

Timeframe: 9 Weeks

Population: All patients who met the study inclusion and exclusion criteria; received all 6 of the induction course intravesical administrations of the investigational product; and had a follow-up cystoscopy during Weeks 8 to 10 and biopsy or TUR of suspicious lesions

Tumor response evaluated at week 9 (range 8-10 weeks) during the first post induction course treatment cystoscopy or TUR of suspiciaous lesions

Outcome measures

Measure	20 mg of BC-819/PEI n=39 Participants Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer \[recurrent stages Ta (low or high grade) and T1 (low grade) TCC\] who have failed prior intravesical therapies including BCG and/or chemotherapy.
Complete Tumor Response Defined as the Absence of New Tumors	64.1 percentage of participants Interval 49.7 to 76.8

SECONDARY outcome

Timeframe: 46 Weeks

The Time to Tumor Recurrence is defined as the interval between the date of the final tumor resection before the start of study treatments to the date when the cystoscopy was performed in which it was confirmed by histopathology that any suspicious lesions that were observed, were TCC of the bladder with the exception of the continued presence of the marker tumor at Week 9

Outcome measures

Measure	20 mg of BC-819/PEI n=39 Participants Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer \[recurrent stages Ta (low or high grade) and T1 (low grade) TCC\] who have failed prior intravesical therapies including BCG and/or chemotherapy.
Time to Tumor Recurrence	11.3 months Interval 2.4 to 52.2

SECONDARY outcome

Timeframe: 9 weeks

Complete disappearance of marker lesion

Outcome measures

Measure	20 mg of BC-819/PEI n=39 Participants Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer \[recurrent stages Ta (low or high grade) and T1 (low grade) TCC\] who have failed prior intravesical therapies including BCG and/or chemotherapy.
Ablative Effect on a Marker Tumor	33.3 percentage of participants Interval 21.0 to 47.7

Adverse Events

20 mg of BC-819/PEI

Serious events: 3 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Measure	20 mg of BC-819/PEI n=47 participants at risk Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer \[recurrent stages Ta (low or high grade) and T1 (low grade) TCC\] who have failed prior intravesical therapies including BCG and/or chemotherapy.
Renal and urinary disorders Urinary retention	2.1% 1/47 • Number of events 1 • Screening through Week 46
Renal and urinary disorders Transurethral prostactectomy	2.1% 1/47 • Number of events 1 • Screening through Week 46
Renal and urinary disorders Urinary tract infection	2.1% 1/47 • Number of events 1 • Screening through Week 46
Cardiac disorders Myocardial infarction	2.1% 1/47 • Number of events 1 • Screening through Week 46
Renal and urinary disorders Hematuria	2.1% 1/47 • Number of events 1 • Screening through Week 46

Other adverse events

Measure	20 mg of BC-819/PEI n=47 participants at risk Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer \[recurrent stages Ta (low or high grade) and T1 (low grade) TCC\] who have failed prior intravesical therapies including BCG and/or chemotherapy.
Gastrointestinal disorders Nausea	6.4% 3/47 • Number of events 3 • Screening through Week 46
General disorders Asthenia	6.4% 3/47 • Number of events 9 • Screening through Week 46
General disorders Chills	6.4% 3/47 • Number of events 5 • Screening through Week 46
General disorders Pyrexia	6.4% 3/47 • Number of events 3 • Screening through Week 46
Renal and urinary disorders Urinary tract infection	10.6% 5/47 • Number of events 6 • Screening through Week 46
Infections and infestations Increased blood potassium	10.6% 5/47 • Number of events 7 • Screening through Week 46
Metabolism and nutrition disorders Metabolism and nutrition disorders	6.4% 3/47 • Number of events 3 • Screening through Week 46
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	12.8% 6/47 • Number of events 6 • Screening through Week 46
Nervous system disorders Nervous system disorders	6.4% 3/47 • Number of events 3 • Screening through Week 46
Renal and urinary disorders Dysuria	10.6% 5/47 • Number of events 18 • Screening through Week 46
Renal and urinary disorders Micturition urgency	6.4% 3/47 • Number of events 9 • Screening through Week 46
Renal and urinary disorders Pollakiuria	14.9% 7/47 • Number of events 12 • Screening through Week 46
Renal and urinary disorders Urinary retention	75.0% 3/4 • Number of events 3 • Screening through Week 46
Respiratory, thoracic and mediastinal disorders Respiratory and thoracic disorders	8.5% 4/47 • Number of events 4 • Screening through Week 46

Additional Information

Dr. Sarel Halachmi

Bnai Zion Medical Center

Phone: +97248359542

Email: sarel.halachmi@b-zion.org.il

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place