Completed

A Phase II Study of Pioglitazone for Patients With Cancer of the Pancreas

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Pioglitazone

+ Pioglitazone

Drug
Who is being recruted

Digestive System Diseases+5

+ Digestive System Neoplasms

+ Endocrine System Diseases

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2013
See protocol details

Summary

Principal SponsorUniversity of Texas Southwestern Medical Center
Last updated: March 1, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2013

Actual date on which the first participant was enrolled.

This study is being done to determine whether or not addition of the oral medication, pioglitazone to standard chemotherapy, results in improvement of blood tests that measure the body's ability to utilize sugar (glucose and insulin metabolism). In addition the investigators want to determine whether or not treatment with pioglitazone results in (1) improvement in the size of the tumor, (2) weight gain, (3) improved ability to function during the day and (4) quality of life.

NCT01838317
Principal SponsorUniversity of Texas Southwestern Medical Center
Last updated: March 1, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

14 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasmsNeoplasms by SitePancreatic DiseasesPancreatic Neoplasms

Criteria

4 inclusion criteria required to participate
ECOG functional status 0-2
Histologically proven adenocarcinoma of the pancreas
Radiologically measurable disease
Signed informed consent
11 exclusion criteria prevent from participating
AST and ALT > 2.5 x ULN, unless there are liver metastases in which case AST and ALT or > 5 x ULN
History of, or active bladder cancer
Hypersensitivity of TZD
Inadequate hepatic function documented within 14 days of enrollment
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

UT Southwestern Medical Center

Dallas, United StatesOpen UT Southwestern Medical Center in Google Maps
CompletedOne Study Center