Trial Outcomes & Findings for A Phase II Study of Pioglitazone for Patients With Cancer of the Pancreas (NCT NCT01838317)

Results Overview

We will obtain serum levels of adiponectin at baseline and after 8 weeks of treatment with pioglitazone.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Baseline and 8 weeks of treatment with pioglitazone

Results posted on

2021-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	Pioglitazone and Chemotherapy Without Diabetes 45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.	Pioglitazone and Chemotherapy - With Diabetes 45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
Overall Study STARTED	9	5
Overall Study COMPLETED	9	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

All Participants received the same treatment. However, results were analyzed separating those individuals with and without diabetes.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pioglitazone and Chemotherapy in Patients Without Diabetes n=9 Participants 45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.	Pioglitazone and Chemotherapy in Patients With Diabetes n=5 Participants 45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.	Total n=14 Participants Total of all reporting groups
Age, Continuous Pioglitazone and Chemotherapy - Without Diabetes	58.26 years STANDARD_DEVIATION 8.52 • n=9 Participants • All Participants received the same treatment. However, results were analyzed separating those individuals with and without diabetes.	64.84 years STANDARD_DEVIATION 8.87 • n=5 Participants • All Participants received the same treatment. However, results were analyzed separating those individuals with and without diabetes.	61.55 years STANDARD_DEVIATION 8.70 • n=14 Participants • All Participants received the same treatment. However, results were analyzed separating those individuals with and without diabetes.
Sex: Female, Male Female	6 Participants n=9 Participants	3 Participants n=5 Participants	9 Participants n=14 Participants
Sex: Female, Male Male	3 Participants n=9 Participants	2 Participants n=5 Participants	5 Participants n=14 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	9 participants n=9 Participants	5 participants n=5 Participants	14 participants n=14 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks of treatment with pioglitazone

We will obtain serum levels of adiponectin at baseline and after 8 weeks of treatment with pioglitazone.

Outcome measures

Outcome measures
Measure	Pioglitazone and Chemotherapy Without Diabetes n=9 Participants 45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.	Pioglitazone and Chemotherapy - With Diabetes n=5 Participants 45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
Change in Serum Adiponectin Level	34.47 μg/ml Standard Deviation 27.42	29.77 μg/ml Standard Deviation 12.06

PRIMARY outcome

Timeframe: Baseline to 120 minutes post glucose bolus

Population: The data was not collected for standard glucose tolerance test.

We will perform the area under the oral glucose tolerance test at baseline and after 8 weeks of treatment with pioglitazone.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Every 4 weeks while receiving treatment, up to 8 weeks

Glucose to insulin ratio will be measured by taking the ratio of fasting level of serum glucose and insulin. We will obtain serum levels of fasting glucose and insulin every four weeks in all patients receiving pioglitazone

Outcome measures

Outcome measures
Measure	Pioglitazone and Chemotherapy Without Diabetes n=9 Participants 45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.	Pioglitazone and Chemotherapy - With Diabetes n=5 Participants 45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
Glucose to Insulin Ratio	0.81 ratio Standard Deviation 13.54	-6.23 ratio Standard Deviation 0.08

SECONDARY outcome

Timeframe: Baseline and every two weeks for 10 weeks, change between baseline and week 10 reported.

Population: There was only 1 patient with data for "with Diabetes" arm, thus Standard Deviation for outcome is 0 for that arm

To describe changes in weight in patients with pancreas cancer receiving pioglitazone.

Outcome measures

Outcome measures
Measure	Pioglitazone and Chemotherapy Without Diabetes n=9 Participants 45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.	Pioglitazone and Chemotherapy - With Diabetes n=1 Participants 45 mg Pioglitazone daily for 8 weeks and continued chemotherapy throughout 10 week study period.
Change in Weight	2.57 kg Standard Deviation 3.98	-4.01 kg Standard Deviation 0

SECONDARY outcome

Timeframe: 8 weeks of treatment with pioglitazone

Population: Tumor assessment not collected. Data was not collected .

Objective response is the proportion of patients with confirmed complete response (CR) or confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 8 weeks of treatment with pioglitazone

Population: Data was not collected.

The ECOG Scale of Performance Status measures patients' performance status. Possible grades range from 0 to 5, with lower grade indicating a better performance status.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 8 weeks of treatment with pioglitazone

Population: Data was not collected

The FACT-Hep Scale (version 4) measures quality of life, It consists of five subscales: (1) physical well-being (PWB); (2) social and family well-being (SFWB); (3) emotional well-being (EWB); (4) functional well-being (FWB); and the hepatobiliary cancer subscale (HepCS). Possible scores range from 0 to 180, with lower scores indicating a better quality of life

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 8 weeks of treatment with pioglitazone

Population: Data was not collected.

Change in pancreatic intratumor fat will be measured by MRI

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 8 weeks of treatment with pioglitazone

Population: This data was not collected as the number of cases with pre and post scans who were with and without DM (Diabetes Mellitus) was too small.

Change in body fast distribution will be measured by MRI

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 8 weeks of treatment with pioglitazone

Population: This data was not collected as the number of cases with pre and post scans who were with and without DM (Diabetes Mellitus) was too small.

Compare changes in serum and MRI end points between pioglitazone

Outcome measures

Outcome data not reported

Adverse Events

Pioglitazone and Chemotherapy Without Diabetes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 9 deaths

Pioglitazone and Chemotherapy - With Diabetes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Muhammad Shaalan Beg

University of Texas Southwestern Medical Center

Phone: 214-648-4180

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place