Trial Outcomes & Findings for Two Stage Study Of Single Dose PEGPH20 And Cetuximab In Patients With Pancreatic Adenocarcinoma Prior To Surgical Resection (NCT NCT02241187)

Last Updated: 2017-09-27

Results Overview

administration on resectable pancreatic adenocarcinoma tumors. DW- and DCE-MRI and distribution of cetuximab will be used to study tumor permeability to small and larger molecules, respectively. Resected tumors will be carefully studied for evidence of stromal degradation.

Recruitment status

COMPLETED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

1 year

Results posted on

2017-09-27

Participant Flow

Protocol Open to Accrual 09/12/2014 Protocol Closed to Accrual N/A Primary Completion Date 09/13/2016 Recruitment Location is the medical clinic

Participant milestones

Participant milestones
Measure	PEGPH20 And Cetuximab 5 participants will undergo DW- \& DCE-MRI for sequence parameter optimization. The 1st stage of the study, patients (n = 5) will have the option to undergo (DW-) \& (DCE)-MRI for repeatability investigation \& T1 mapping. Optional DW- \& DCE-MRI will be repeated 2 to 5 days later, followed shortly by administration of 1 intravenous dose of cetuximab at 250 mg/m2/60 min. Pancreatic tumor resection will be performed 1 to 2 days later.Blood samples will be drawn at various time points. The resected tumor specimen will be studied. If deemed safe, we will proceed to the second stage of the study. Patients (n = 5) will have the option to undergo DW- \& DCE-MRI. 1 to 3 days later, patients will receive 1 IV dose of PEGPH20 at 3 μg/kg/10 min. Optional DW- \& DCE-MRI will be repeated 1 to 2 days after PEGPH20 administration, followed on that day by administration of 1 IV dose of cetuximab at 250 mg/m2/60 min. Pancreatic tumor resection will be performed 1 to 2 days later. PEGPH20 Cetuximab
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	PEGPH20 And Cetuximab 5 participants will undergo DW- \& DCE-MRI for sequence parameter optimization. The 1st stage of the study, patients (n = 5) will have the option to undergo (DW-) \& (DCE)-MRI for repeatability investigation \& T1 mapping. Optional DW- \& DCE-MRI will be repeated 2 to 5 days later, followed shortly by administration of 1 intravenous dose of cetuximab at 250 mg/m2/60 min. Pancreatic tumor resection will be performed 1 to 2 days later.Blood samples will be drawn at various time points. The resected tumor specimen will be studied. If deemed safe, we will proceed to the second stage of the study. Patients (n = 5) will have the option to undergo DW- \& DCE-MRI. 1 to 3 days later, patients will receive 1 IV dose of PEGPH20 at 3 μg/kg/10 min. Optional DW- \& DCE-MRI will be repeated 1 to 2 days after PEGPH20 administration, followed on that day by administration of 1 IV dose of cetuximab at 250 mg/m2/60 min. Pancreatic tumor resection will be performed 1 to 2 days later. PEGPH20 Cetuximab
Overall Study Protocol closed due to lack of accrual.	2

Baseline Characteristics

Two Stage Study Of Single Dose PEGPH20 And Cetuximab In Patients With Pancreatic Adenocarcinoma Prior To Surgical Resection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PEGPH20 And Cetuximab n=2 Participants Participants have radiographically resectable Pancreatic ductal adenocarcinoma (PDAC) without evidence of distant metastases by CT or laparoscopy. However, the two participants accrued to this study were healthy participants.
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The two participants accrued to this study were healthy participants. No participants were accrued on study for treatment. No data were collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: The two participants accrued to this study were healthy participants. No participants were accrued on study for treatment. No data were collected.

in close proximity to surgical resection of pancreatic adenocarcinoma. Safety with regards to operative and post-operative complications will be characterized.

Outcome measures

Outcome data not reported

Adverse Events

PEGPH20 And Cetuximab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kenneth Yu, MD

Memorial Sloan Kettering Cancer Center

Phone: 646-888-4188

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place