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.
COMPLETED
PHASE1/PHASE2
9 participants
Week 4
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
| 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
| 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 4Population: 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
| 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 weeksTumor 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
| 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 weeksThe 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
| 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
BC-819 8 mg
Serious adverse events
Adverse event data not reported
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place