A Phase II Study of Pioglitazone for patients with cancer of the pancreas

Study ID
STU 072012-036

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

Contact
Tyson Dudley
214-648-7031
tyson.dudley@utsouthwestern.edu

Principal Investigator
Muhammad Beg

Summary

This is an open label, double arm Phase 2 study.

Study arm:
We plan to enroll fifteen patients with metastatic or locally advanced pancreas cancer into a double arm pilot exploratory study of oral pioglitazone 45 mg daily.
Treatment will be administered for 8 weeks and then stopped.

Control arm:
up to ten patients meeting eligibility criteria will be enrolled in the control arm. Patients will be treated per standard of care treatment at the discretion of the treating team and will not be treated with pioglitazone.

Treatment arm assignment:
Treatment arm will be assigned by the principal investigator or treating MD at their discretion. Given the exploratory nature of this study, randomization will not be performed.

Control arm patients can include the following examples:
- patient declines pioglitazone therapy but agrees to biomarker testing
- Patient is enrolled in another clinical trial which does not allow experimental therapy (pioglitazone) to be given. The protocol of the patient's study will be reviewed to ensure biomarker testing as defined in this study is not specifically prohibited.
- Patients enrolled after completion of the 15 study arm patients
- other patients as deemed appropriate by the Pi or co-is

Randomization is not being performed. Due to feasibility and small number of eligible patients, investigator discretion will be used to assign a study arm.

Participant Eligibility

1. Histologically proven adenocarcinoma of the pancreas
2. Radiologically measureable disease
3. ECOG functional status 0-2
4. Signed informed consent