Trial Outcomes & Findings for A Dose Escalation Safety Study of Locally-Delivered Gemcitabine in Pancreatic Cancer (NCT NCT02237157)
NCT ID: NCT02237157
Last Updated: 2021-05-07
Results Overview
Maximum Tolerated Dose (MTD) of gemcitabine administered intra-arterially to the pancreatic tumor(s) using the RenovoCath™ RC120 catheter. One week post treatment, toxicities will be assessed to determine if there is a pre-defined Dose Limiting Toxicity necessitating dose stopping or holding.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
1 week post treatment
Results posted on
2021-05-07
Participant Flow
Subjects who complete a cycle ("arm"/"period") then proceed to receive the next higher dose.
Participant milestones
| Measure |
Gemcitabine, Local Delivery (Dose 1)
Gemcitabine; 1 cycles, two doses per cycle; 250mg/m2 dose
Gemcitabine, local delivery: Intra-arterial targeted drug delivery
|
Gemcitabine, Local Delivery (Dose 2)
Gemcitabine; 1 cycles, two doses per cycle; 500mg/m2 dose
Gemcitabine, local delivery: Intra-arterial targeted drug delivery
|
Gemcitabine, Local Delivery (Dose 3)
Gemcitabine; 1 cycles, two doses per cycle; 750mg/m2 dose
Gemcitabine, local delivery: Intra-arterial targeted drug delivery
|
Gemcitabine, Local Delivery (Dose 4)
Gemcitabine; 1 cycles, two doses per cycle; 1000mg/m2 dose
Gemcitabine, local delivery: Intra-arterial targeted drug delivery
|
|---|---|---|---|---|
|
Gemcitabine, Local Delivery (Dose 1)
STARTED
|
20
|
0
|
0
|
0
|
|
Gemcitabine, Local Delivery (Dose 1)
COMPLETED
|
16
|
0
|
0
|
0
|
|
Gemcitabine, Local Delivery (Dose 1)
NOT COMPLETED
|
4
|
0
|
0
|
0
|
|
Gemcitabine, Local Delivery (Dose 2)
STARTED
|
0
|
15
|
0
|
0
|
|
Gemcitabine, Local Delivery (Dose 2)
COMPLETED
|
0
|
15
|
0
|
0
|
|
Gemcitabine, Local Delivery (Dose 2)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Gemcitabine, Local Delivery (Dose 3)
STARTED
|
0
|
0
|
11
|
0
|
|
Gemcitabine, Local Delivery (Dose 3)
COMPLETED
|
0
|
0
|
11
|
0
|
|
Gemcitabine, Local Delivery (Dose 3)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Gemcitabine, Local Delivery (Dose 4)
STARTED
|
0
|
0
|
0
|
8
|
|
Gemcitabine, Local Delivery (Dose 4)
COMPLETED
|
0
|
0
|
0
|
8
|
|
Gemcitabine, Local Delivery (Dose 4)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Gemcitabine, Local Delivery (Dose 1)
Gemcitabine; 1 cycles, two doses per cycle; 250mg/m2 dose
Gemcitabine, local delivery: Intra-arterial targeted drug delivery
|
Gemcitabine, Local Delivery (Dose 2)
Gemcitabine; 1 cycles, two doses per cycle; 500mg/m2 dose
Gemcitabine, local delivery: Intra-arterial targeted drug delivery
|
Gemcitabine, Local Delivery (Dose 3)
Gemcitabine; 1 cycles, two doses per cycle; 750mg/m2 dose
Gemcitabine, local delivery: Intra-arterial targeted drug delivery
|
Gemcitabine, Local Delivery (Dose 4)
Gemcitabine; 1 cycles, two doses per cycle; 1000mg/m2 dose
Gemcitabine, local delivery: Intra-arterial targeted drug delivery
|
|---|---|---|---|---|
|
Gemcitabine, Local Delivery (Dose 1)
Adverse Event
|
3
|
0
|
0
|
0
|
|
Gemcitabine, Local Delivery (Dose 1)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Dose Escalation Safety Study of Locally-Delivered Gemcitabine in Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine, Local Delivery
n=20 Participants
Gemcitabine; 4 cycles, two doses per cycle; dose escalation
Gemcitabine, local delivery: Intra-arterial targeted drug delivery
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=39 Participants
|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 9.72 • n=39 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 1 week post treatmentMaximum Tolerated Dose (MTD) of gemcitabine administered intra-arterially to the pancreatic tumor(s) using the RenovoCath™ RC120 catheter. One week post treatment, toxicities will be assessed to determine if there is a pre-defined Dose Limiting Toxicity necessitating dose stopping or holding.
Outcome measures
| Measure |
Gemcitabine, Local Delivery
n=20 Participants
Gemcitabine; 4 cycles, two doses per cycle; dose escalation
Gemcitabine, local delivery: Intra-arterial targeted drug delivery
|
|---|---|
|
Determine the Maximum Tolerated Dose of Gemcitabine to be Delivered Locally to the Pancreas
|
1000 mg/m^2
|
SECONDARY outcome
Timeframe: 1 week after treatmentMeasurements of CA19-9 tumor marker are measured pre-treatment and at various time points (starting with one week) post treatment.
Outcome measures
Outcome data not reported
Adverse Events
Gemcitabine, Local Delivery (Dose 1)
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Gemcitabine, Local Delivery (Dose 2)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Gemcitabine, Local Delivery (Dose 3)
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Gemcitabine, Local Delivery (Dose 4)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine, Local Delivery (Dose 1)
n=20 participants at risk
Gemcitabine; 1 cycle, two doses per cycle; 250mg/m2 dose
Gemcitabine, local delivery: Intra-arterial targeted drug delivery
|
Gemcitabine, Local Delivery (Dose 2)
n=15 participants at risk
Gemcitabine; 1 cycle, two doses per cycle; 500mg/m2 dose
Gemcitabine, local delivery: Intra-arterial targeted drug delivery
|
Gemcitabine, Local Delivery (Dose 3)
n=11 participants at risk
Gemcitabine; 1 cycle, two doses per cycle; 750mg/m2 dose
Gemcitabine, local delivery: Intra-arterial targeted drug delivery
|
Gemcitabine, Local Delivery (Dose 4)
n=8 participants at risk
Gemcitabine; 1 cycle, two doses per cycle; 1000mg/m2 dose
Gemcitabine, local delivery: Intra-arterial targeted drug delivery
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/15 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/11 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/8 • Adverse events were collected during the treatment period, an average of 2.5 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/20 • Adverse events were collected during the treatment period, an average of 2.5 months
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/11 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/8 • Adverse events were collected during the treatment period, an average of 2.5 months
|
|
Injury, poisoning and procedural complications
Duodenal Obstruction
|
0.00%
0/20 • Adverse events were collected during the treatment period, an average of 2.5 months
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/11 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/8 • Adverse events were collected during the treatment period, an average of 2.5 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/20 • Adverse events were collected during the treatment period, an average of 2.5 months
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/11 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/8 • Adverse events were collected during the treatment period, an average of 2.5 months
|
|
Infections and infestations
Infection
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/15 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/11 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/8 • Adverse events were collected during the treatment period, an average of 2.5 months
|
|
Injury, poisoning and procedural complications
Intraoperative Arterial Injury / Dissection
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/8 • Adverse events were collected during the treatment period, an average of 2.5 months
|
|
Injury, poisoning and procedural complications
Intraoperative Arterial Injury - Lower Extremity
|
0.00%
0/20 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/15 • Adverse events were collected during the treatment period, an average of 2.5 months
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/8 • Adverse events were collected during the treatment period, an average of 2.5 months
|
|
Gastrointestinal disorders
Pain - Abdominal (NOS)
|
0.00%
0/20 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/15 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/11 • Adverse events were collected during the treatment period, an average of 2.5 months
|
12.5%
1/8 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/20 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/15 • Adverse events were collected during the treatment period, an average of 2.5 months
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/8 • Adverse events were collected during the treatment period, an average of 2.5 months
|
|
Blood and lymphatic system disorders
Sepsis
|
10.0%
2/20 • Number of events 2 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/15 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/11 • Adverse events were collected during the treatment period, an average of 2.5 months
|
12.5%
1/8 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
Other adverse events
| Measure |
Gemcitabine, Local Delivery (Dose 1)
n=20 participants at risk
Gemcitabine; 1 cycle, two doses per cycle; 250mg/m2 dose
Gemcitabine, local delivery: Intra-arterial targeted drug delivery
|
Gemcitabine, Local Delivery (Dose 2)
n=15 participants at risk
Gemcitabine; 1 cycle, two doses per cycle; 500mg/m2 dose
Gemcitabine, local delivery: Intra-arterial targeted drug delivery
|
Gemcitabine, Local Delivery (Dose 3)
n=11 participants at risk
Gemcitabine; 1 cycle, two doses per cycle; 750mg/m2 dose
Gemcitabine, local delivery: Intra-arterial targeted drug delivery
|
Gemcitabine, Local Delivery (Dose 4)
n=8 participants at risk
Gemcitabine; 1 cycle, two doses per cycle; 1000mg/m2 dose
Gemcitabine, local delivery: Intra-arterial targeted drug delivery
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
13.3%
2/15 • Number of events 2 • Adverse events were collected during the treatment period, an average of 2.5 months
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/8 • Adverse events were collected during the treatment period, an average of 2.5 months
|
|
Vascular disorders
Arterial spasm
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/15 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/11 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/8 • Adverse events were collected during the treatment period, an average of 2.5 months
|
|
General disorders
Chills
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/15 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/11 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/8 • Adverse events were collected during the treatment period, an average of 2.5 months
|
|
General disorders
Fever
|
0.00%
0/20 • Adverse events were collected during the treatment period, an average of 2.5 months
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/8 • Adverse events were collected during the treatment period, an average of 2.5 months
|
|
Gastrointestinal disorders
Incontinence
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/15 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/11 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/8 • Adverse events were collected during the treatment period, an average of 2.5 months
|
|
Injury, poisoning and procedural complications
Intraoperative arterial injury - lower extremity
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/15 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/11 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/8 • Adverse events were collected during the treatment period, an average of 2.5 months
|
|
Injury, poisoning and procedural complications
Intraoperative arterial injury - pseudoaneurysm
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/15 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/11 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/8 • Adverse events were collected during the treatment period, an average of 2.5 months
|
|
Musculoskeletal and connective tissue disorders
Median arcuate ligament syndrome
|
0.00%
0/20 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/15 • Adverse events were collected during the treatment period, an average of 2.5 months
|
9.1%
1/11 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/8 • Adverse events were collected during the treatment period, an average of 2.5 months
|
|
Ear and labyrinth disorders
Nausea
|
5.0%
1/20 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/11 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/8 • Adverse events were collected during the treatment period, an average of 2.5 months
|
|
Vascular disorders
Vasovagal episode
|
0.00%
0/20 • Adverse events were collected during the treatment period, an average of 2.5 months
|
6.7%
1/15 • Number of events 1 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/11 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/8 • Adverse events were collected during the treatment period, an average of 2.5 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • Adverse events were collected during the treatment period, an average of 2.5 months
|
13.3%
2/15 • Number of events 2 • Adverse events were collected during the treatment period, an average of 2.5 months
|
9.1%
1/11 • Number of events 2 • Adverse events were collected during the treatment period, an average of 2.5 months
|
0.00%
0/8 • Adverse events were collected during the treatment period, an average of 2.5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place