IRB Number:

07-005208

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

Patients are being asked to take part in this research study because they have advanced pancreatic cancer and are a candidate for chemotherapy with a drug called gemcitabine, which is currently a standard treatment for pancreatic cancer.

This study is being done to find out what dose of a new drug, named AEG35156, given in combination with the standard chemotherapy drug, gemcitabine, will work the best and without causing unacceptable side effects.

The study drug AEG35156 is not approved by the U.S. Food and Drug Administration (FDA) for use outside of this clinical study. Gemcitabine is a chemotherapy drug which has been approved by FDA for the treatment of advance pancreatic cancer.

The primary purpose of this study is to:
- Find out how much of the study drug (AEG35156), when taken with standard doses of gemcitabine, can be given without causing bad side effects
- See if the study drug can improve the effectiveness of the gemcitabine

Who is Eligible to Participate in the Study?

- Age 18 or older
- Diagnosed with advanced pancreatic cancer and are a candidate for chemotherapy with a drug called gemcitabine

* More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

If agreeing to be in the study, the patient will be asked to participate in the following:

Screening Visit (To see if eligible to participate in the study)
The following tests will be run during the Screening Visit. All of these tests may be completed over several clinic visits and might not be repeated if a recent test result (within a week) is already available in the patient's medical records:
- The doctor or nurse will interview the patient for a full medical history, and obtain a list of all medications that are currently being taken.
- A full physical examination with vital signs (heart rate, blood pressure, breathing rate and body temperature) and body weight will be recorded. The study doctor will examine the patient.
- Blood will be drawn for routine lab tests.
- Blood tests will be taken to make sure the patient does not have HIV, hepatitis B or hepatitis C.
- Blood test for CA19-9, a substance in the blood called a tumor marker, will be done.
- If patient is a woman who is able to become pregnant, a pregnancy test will be done.
- CT scan and/or MRI of the patient's abdomen will be done. If these tests were done within the last 28 days, those results will become part of the patient's research records for this study.

Treatment:
Chemotherapy for cancer is administered over various periods of time referred to as cycles. In this study, one treatment cycle is four weeks (28 days) in duration and will be repeated for as long as the patient continues to tolerate the treatment and their cancer does not get worse.

For the first treatment cycle, during Week 1 the patient will receive AEG35156 two days in a row through a vein in their arm. Each treatment will last two hours. On the third day of the cycle, the patient will receive the AEG35156 followed by their first dose of gemcitabine. This will take another half an hour.

During Week 2 and Week 3 the patient will receive one treatment of AEG35156 followed by gemcitabine.

Week 4 is a week of rest with no treatment.

All subsequent cycles will be comprised of weekly treatments with AEG35156 followed by gemcitabine for three weeks followed by one week with no treatment. Each treatment will last for approximately two and one half to three hours. Patients may also receive anti-nausea medications through a vein prior to the chemotherapy.

Prior to the start of every new cycle, the following tests will be done to make sure it is safe for the patient to continue on the study:
- Blood will be drawn for routine lab tests.
- A full physical examination with vital signs (heart rate, blood pressure, breathing rate and body temperature) and body weight will be recorded. The study doctor will examine the patient.

Prior to the treatments during Weeks 2 and 3 of each cycle, the following tests will be done to make sure it is safe for the patient to receive the scheduled treatment:
- Blood will be drawn for routine lab tests.

At the end of every two cycles, CT scans and/or MRI of the patient's abdomen and a blood test for CA19-9 will be repeated to help the study doctor determine the response of the patient's cancer to the treatment.

End of treatment:
The following tests will be done when the patient's treatments are discontinued:
- A full physical examination with vital signs (heart rate, blood pressure, breathing rate and body temperature) and body weight will be recorded. The study doctor will examine the patient.
- Blood will be drawn for routine lab tests.
- Blood test for CA19-9 will be done.
- CT scan and/or other radiology studies will be repeated if not done within the past four weeks.
Some patients may be seen every month after they finish the treatments, to determine their long term response to the therapy.

How long will the Study run?

Patients will be in the study as long as the study drug is tolerated, and their cancer does not grow.

Sponsor(s): Aegera Therapeutics, Inc.

Study Activation/Registration Date: 11/27/2007

IRB Review and Approval Date: 11/01/2007

Study Type: Dosing/Treatment

Projected Accrual: The plan is to have up to 48 patients participate from multiple medical centers.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Donald Northfelt, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Scottsdale and Phoenix, AZ

Last updated: 11/20/2008