IRB Number:

06-006332

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

Patients are being asked to take part in this research study because they have cancer that has continued to grow despite the treatments they may have already received. Either the standard drugs used to treat their disease are no longer working or there are no known treatments that work because the patient's tumor cells may be resistant to these treatments. This clinical trial is about testing ZEN-012 which is a newly discovered chemical compound. It belongs to a group of drugs which may stop tumor cell growth.
This study is being done to:
- test the safety of ZEN-012 and see what effect (good and bad) it has on the patient and their cancer
- find the highest dose of ZEN-012 that can be given without causing bad side effects.

Who is Eligible to Participate in the Study?

-Age 18 or older
-Diagnosed with cancer (solid tumor or lymphoma) that has continued to grow despite the treatments the patient may have already received. Either the standard drugs used to treat the patient's disease are no longer working or there are no known treatments that work because the patient's tumor cells may be resistant to these treatments.

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

What is Involved With this Study?

At the beginning of the study, 3 patients will be treated with a low dose of the drug. If this dose does not cause bad side effects, doses will be slowly increased as new patients take part in the study. The dose that the patient is treated with will be the same for the length of time they are on the study.

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

Screening Visit (To see if the patient is eligible to participate in the study)
The following tests will be done during the Screening Visit. All of these tests may be completed over several clinic visits, and will not be repeated if a recent test result is already available in the patient's medical records:
- The Doctor or Nurse will ask the patient about their medical history, and obtain a list of all medications that the patient is currently taking.
- A full physical examination with vital signs (heart rate, blood pressure, breathing rate and body temperature) height and body weight will be recorded.
- An electrocardiogram (ECG - a recording of the electrical activity of the heart)will be performed.
- Blood will be drawn for routine lab tests.
- Urine will be collected for routine lab tests.
- The study Doctor will examine the patient and may order additional x-rays to show the extent of the patient's cancer.
- Pregnancy test for women able to become pregnant

During the study, the health care team will talk about cycles of treatment. A cycle is a scheduled period of time for taking cancer treatment drugs. This clinical trial runs in cycles of four weeks (28 days), which may be repeated as long as the patient continues to receive the study drug, ZEN-012.
Patients will receive study drug orally (by mouth) once a week for three out of four weeks.

Baseline Evaluations/Procedures (Day 1, Cycle 1; can be up to 24 hours prior to this day)
- The Doctor or Nurse will ask the patient to tell them about any unpleasant effects the patient may have felt since the last clinic visit, and to obtain a list of all medications that the patient is currently taking.
- A full physical examination will be done unless the screening physical examination was done seven days or less prior to Baseline.
- Vital signs (heart rate, blood pressure, breathing rate and body temperature) and body weight will be recorded.
- An electrocardiogram (ECG - a recording of the electrical activity of the heart)will be performed before and and approximately 6 hours after the patient receives study drug.
- Blood will be drawn for routine lab tests unless screening blood tests were done seven days or less prior to Baseline..
- Additional blood samples will be collected on Day 1 of the first treatment cycle for specialized blood tests. Patients will need to remain at the clinic for several hours longer on Days 1 of treatment in the first and second cycle only.
- Urine will be collected for routine lab tests unless screening urine test was done seven days or less prior to Baseline.

Cycle 1 (Days 2 to 28)
- The Doctor or Nurse will ask the patient to tell them about any unpleasant effects the patient may have felt since the last clinic visit, and to obtain a list of all medications that the patient is currently taking.
- A full physical examination may be repeated as necessary.
- Vital signs (heart rate, blood pressure, breathing rate and body temperature)will be recorded
- An electrocardiogram (ECG - a recording of the electrical activity of the heart)will be done on Day 15 before and and approximately six hours after the patient receives their third dose of study drug.
- Blood will be drawn for routine lab tests up to 24 hours prior to each dose.
- Additional blood samples will be collected on Day 2, Day 3 and Day 4 after the patient's first dose of study drug and before dosing on Day 8.
- Additional blood samples will be collected on Day 15 in the same manner as day 1. The patient will need to remain in the clinic for several hours longer on this day.
- An additional blood sample will be collected on Day 22 in the morning.
- The study Doctor will examine the patient and may order additional x-rays to show the extent of the patient's cancer (between Days 22 and 28).

Cycle 2 through Cycle 4 (Weekly)
- The Doctor or Nurse will ask the patient to tell them about any unpleasant effects the patient may have felt since the last Clinic visit, and to obtain a list of all medications that the patient is currently taking.
- A full physical examination will be performed on Day 1 of each cycle and will be repeated as necessary.
- Vital signs (heart rate, blood pressure, breathing rate and body temperature)and body weight will be recorded on Day 1 and their vital signs repeated each week.
- An electrocardiogram (ECG - a recording of the electrical activity of the heart)will be done before the patient receives their dose of study drug on Day 1 of each cycle.
For Cycle 2, an electrocardiogram will also be done approximately six hours after The patient receives the medication.
- Blood will be drawn for routine lab tests.
- Urine will be collected for routine lab tests (Day 1 only).
- Additional blood samples will be collected (as listed below) during Cycle 2 only Day 1: before dosing and 30 minutes, one, two, four, and eight hours after dosing
Days 8 and 15: before dosing;Day 22: in the morning and Day 1 of Cycle 3: before dosing
- The study Doctor will examine the patient and may order additional x-rays to show the extent of their cancer (every other cycle between Days 22 and 28). In addition, scans to monitor the patient's disease will be obtained prior to starting cycle 2 and then every other treatment cycle.

Post-Treatment Visits
- The Doctor or Nurse will ask the patient to tell them about any unpleasant effects the patient may have felt since the last clinic visit, and to obtain a list of all medications that the patient is currently taking.
- A full physical examination with vital signs (heart rate, blood pressure, breathing rate and body temperature) and body weight will be recorded.
- An electrocardiogram (ECG - a recording of the electrical activity of the heart)will be done.
- Blood will be drawn for routine lab tests. Additional blood samples may be collected in some cases for specialized cancer tests.
- Urine will be collected for routine lab tests.
- The study Doctor will examine the patient and may order additional x-rays to record the extent of their cancer.
- At the end of the study treatment the patient will have a phone call 30 days after the study drug is given by the study team.

How long will the Study run?

Patients will be in the study for a minimum of up to four cycles of treatment depending on how the study drug affects their cancer and if it causes the patient to have side effects that are either dangerous for the patient or that they cannot tolerate. Treatment will be continued every four weeks (three weeks of treatment and one week of rest) until they experience intolerable side effects or their disease worsens.

Sponsor(s): Zentaris GmbH

Study Activation/Registration Date: 03/27/2007

IRB Review and Approval Date: 03/02/2007

Study Type: Dosing/Treatment

Projected Accrual: The plan is to have up to 50 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 W. 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: 08/28/2008