Trial Outcomes & Findings for Gemcitabine and CT-011 for Resected Pancreatic Cancer (NCT NCT01313416)

NCT ID: NCT01313416

Last Updated: 2019-07-10

Results Overview

Patients presenting with symptoms possibly related to autoimmune reaction will be evaluated for organ specific autoimmune involvement, i.e: * Acute abdominal symptoms should be evaluated for pancreatitis, including lipase and amylase levels; * Persistent diarrhea should be evaluated for infection (c. diff). Any suspicion of colitis should be evaluated by a colonoscopy with biopsy. * Visual symptoms should be immediately evaluated by an ophthalmologist. * Generalized rash should be biopsied prior to local skin care, antihistamines or corticosteroids. * Pulmonary symptoms will be evaluated immediately, including repeated PFTs (pulmonary function tests).

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2019-07-10

Participant Flow

Participant milestones

Measure	Single Arm Combination CT-011 and Gemcitabine CT-011: 3mg/kg, intravenous (IV) day 1 of each cycle over 2 hours. Gemcitabine: 1000mg/m\^2 intravenous (IV) over 30 minutes on days 8, 15, and 22 of each cycle.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gemcitabine and CT-011 for Resected Pancreatic Cancer

Baseline characteristics by cohort

Measure	Single Arm n=2 Participants Combination CT-011 and Gemcitabine CT-011: 3mg/kg, intravenous (IV) day 1 of each cycle over 2 hours. Gemcitabine: 1000mg/m\^2 intravenous (IV) over 30 minutes on days 8, 15, and 22 of each cycle.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 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: 2 years

Population: Study discontinued due to drug supply issues prior to analysis; no meaningful data derived.

Patients presenting with symptoms possibly related to autoimmune reaction will be evaluated for organ specific autoimmune involvement, i.e:

• Acute abdominal symptoms should be evaluated for pancreatitis, including lipase and amylase levels;
• Persistent diarrhea should be evaluated for infection (c. diff). Any suspicion of colitis should be evaluated by a colonoscopy with biopsy.
• Visual symptoms should be immediately evaluated by an ophthalmologist.
• Generalized rash should be biopsied prior to local skin care, antihistamines or corticosteroids.
• Pulmonary symptoms will be evaluated immediately, including repeated PFTs (pulmonary function tests).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Study discontinued due to drug supply issues prior to analysis; no meaningful data derived.

Patients who have received at least one cycle of therapy will be evaluated for response every 8 weeks (every other cycle). Confirmatory scans will be obtained 4 weeks following initial documentation of objective or non-target disease response.

Response will be evaluated on target and non-target lesions. The same method of assessment and same technique will be used to characterize each identified and reported lesion at baseline and during follow-up. Response will be reported as:

• Complete Response (CR); Disappearance of all target lesions
• Partial Response (PR); At least 30% decrease in the sum of the diameters of target lesions
• Progressive Disease (PD): At least 20% increase in the sum of the diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm.
• Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Outcome measures

Outcome data not reported

Adverse Events

Single Arm

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. Samir Khleif

Georgetown University

Phone: (202) 687-0100

Email: snk48@georgetown.edu

Results disclosure agreements

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

Restriction type: OTHER