Trial Outcomes & Findings for Phase 1/2a DTA-H19 in Patients With Unresectable Pancreatic Cancer (NCT NCT00711997)

NCT ID: NCT00711997

Last Updated: 2019-03-20

Results Overview

If 2 patients in any cohort experience DLTs, then the next lower dose will be considered the MTD if there is a lower dose cohort. A DLT is defined as grade 3 or greater toxicity judged to be at least possibly related to the investigational products.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Week 4

Results posted on

2019-03-20

Participant Flow

First subject enrolled: 26 Oct 2009 Last subject completed: 7 Oct 2010 at 4 medical centers in Israel an 1 in US

Of the 16 patients screened, 7 were screening failures due to metastatic disease

Participant milestones

Participant milestones
Measure
BC-819 4 mg
Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection.
BC-819 8 mg
Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 2 mL of 4 mg/mL for a total of 8 mg of BC-819.
Overall Study
STARTED
3
6
Overall Study
COMPLETED
3
6
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 1/2a DTA-H19 in Patients With Unresectable Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
BC-819 4 mg
n=3 Participants
BC-819 8 mg
n=6 Participants
Total
n=9 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
n=5 Participants
5 Participants
n=7 Participants
7 Participants
n=5 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Age, Continuous
64 years
STANDARD_DEVIATION 18.3 • n=5 Participants
60 years
STANDARD_DEVIATION 10 • n=7 Participants
62 years
STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
5 Participants
n=7 Participants
6 Participants
n=5 Participants
Region of Enrollment
United States
0 participants
n=5 Participants
1 participants
n=7 Participants
1 participants
n=5 Participants
Region of Enrollment
Israel
3 participants
n=5 Participants
5 participants
n=7 Participants
8 participants
n=5 Participants

PRIMARY outcome

Timeframe: Week 4

Population: All participants had to receive all 4 scheduled treatments and completed the Week 4 assessment

If 2 patients in any cohort experience DLTs, then the next lower dose will be considered the MTD if there is a lower dose cohort. A DLT is defined as grade 3 or greater toxicity judged to be at least possibly related to the investigational products.

Outcome measures

Outcome measures
Measure
BC-819 4 mg
n=3 Participants
Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection.
BC-819 8 mg
n=6 Participants
Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 2 mL of 4 mg/mL for a total of 8 mg of BC-819.
Maximal Tolerated Dose (MTD) & Dose Limiting Toxicity (DLT) of Intratumoral Injections of BC-819
0 participants
1 participants

SECONDARY outcome

Timeframe: 4 weeks

Tumor response and progression were defined in accordance with RECIST v. 1.0 and assessed by radiological examination 2 weeks after the end of treatment

Outcome measures

Outcome measures
Measure
BC-819 4 mg
n=3 Participants
Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection.
BC-819 8 mg
n=6 Participants
Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 2 mL of 4 mg/mL for a total of 8 mg of BC-819.
Tumor Response
Stable disease
1 participants
4 participants
Tumor Response
Progressive disease
2 participants
2 participants

SECONDARY outcome

Timeframe: 5 to 6 weeks

The number of subjects in each cohort whose tumor was resectable at the end of the study was to be presented for the ITT and the per-protocol population.

Outcome measures

Outcome measures
Measure
BC-819 4 mg
n=3 Participants
Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection.
BC-819 8 mg
n=6 Participants
Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 2 mL of 4 mg/mL for a total of 8 mg of BC-819.
Tumor Resectability
0 participants
1 participants

Adverse Events

BC-819 4 mg

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

BC-819 8 mg

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
BC-819 4 mg
n=3 participants at risk
1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection for 2 weeks of twice weekly intratumoral BC-819.
BC-819 8 mg
n=6 participants at risk
2 mL of 4 mg/mL for a total of 8 mg of BC-819 per injection for 2 weeks of twice weekly intratumoral BC-819.
Gastrointestinal disorders
Abdominal pain & Diarrhea
33.3%
1/3 • Number of events 1
33.3%
2/6 • Number of events 2
Investigations
Lab abnormalities
100.0%
3/3 • Number of events 7
100.0%
6/6 • Number of events 15
Musculoskeletal and connective tissue disorders
Back pain
33.3%
1/3 • Number of events 1
16.7%
1/6 • Number of events 1
Vascular disorders
Hypertension
33.3%
1/3 • Number of events 1
16.7%
1/6 • Number of events 1
General disorders
General disorders
0.00%
0/3
16.7%
1/6 • Number of events 4
Metabolism and nutrition disorders
Hyperglycemia & hypoglycemia
0.00%
0/3
33.3%
2/6 • Number of events 2
Nervous system disorders
Vasovagal syncope
0.00%
0/3
16.7%
1/6 • Number of events 1

Additional Information

Monique Ben-Am, M.Sc.

BioCancell Ltd.

Phone: +972-2-5486533

Results disclosure agreements

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