Trial Outcomes & Findings for A Pilot Study, Evaluating the Efficacy of Regulatory T-cell Suppression by Ontak in Metastatic Pancreatic Cancer (NCT NCT00726037)

NCT ID: NCT00726037

Last Updated: 2016-09-29

Results Overview

The duration of T reg suppression from a fractionated dose of Ontak in patients will be measured in patients with metastatic pancreatic cancer.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 7 participants
• Primary outcome timeframe: days 8, 12 ,19,26 and 33 post administration
• Results posted on: 2016-09-29

Participant Flow

Recruitment for this study began on 06/18/2008 and ended on 01/09/2012

Participant milestones

Measure	Ontak Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study, Evaluating the Efficacy of Regulatory T-cell Suppression by Ontak in Metastatic Pancreatic Cancer

Baseline characteristics by cohort

Measure	Ontak n=7 Participants Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: days 8, 12 ,19,26 and 33 post administration

Population: Zero participants were analyzed, because the manufacturer withdrew support for the study due to a drug supply interruption

The duration of T reg suppression from a fractionated dose of Ontak in patients will be measured in patients with metastatic pancreatic cancer.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 33 Days

Population: Zero participants were analyzed, because the manufacturer withdrew support for the study due to a drug supply interruption

The goal is to define the optimal time with 95% sensitivity and 95% specificity for future dendritic cell vaccine administration

Outcome measures

Outcome data not reported

Adverse Events

Ontak

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

Margret Shoup

Northwestern Medicine Regional Medical Group

Phone: 630-352-5450

Email: MSHOUP@lumc.edu

Results disclosure agreements

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