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Study to Assess OPB-31121 in Advanced Leukemias or Myelodysplastic Syndromes

2014-08-27 03:17:24 | BioPortfolio

Summary

The goal of this clinical research study is to find the highest tolerable dose of OPB-31121 that can be given to patients with leukemia or myelodysplastic syndrome (MDS).

Description

The Study Drug:

In studies that have been performed in animals, OPB-31121 has been shown to stop certain changes to proteins in the body. Stopping these changes may have an effect on tumor cells. How OPB-31121 works is not fully known.

Study Groups:

The first 3 participants enrolled in the study will receive the lowest level of OPB-31121. Each additional group of 3 or 4 participants will receive a dose level dependent upon how the previous group responded to the study drug.

You may have up to 13 study "cycles" (about 273 days). During each 21 day study cycle, you will receive the study drug for 1 week and then "rest" (no study drug) for 7 days.

Study Drug Administration:

The study drug is a pill that should be taken at the same time each day. You should drink 8 ounces (1 cup) of room temperature, non-carbonated water when you take the study drug.

You will eat a snack or meal within 30 minutes after taking the study drug. You should remain sitting upright or standing for at least 30 minutes after taking the drug.

Study Visits for AML, ALL, or MDS participants:

On Day 1 of Cycle 1, you will have the following tests and procedures performed:

- You will have a physical exam, including measurement of your vital signs.

- You will have an ECG.

- Urine will be collected for routine tests.

- Women who are able to have children will have a urine pregnancy test.

- Blood (about 6 tablespoons total) will be drawn about 12 times, with the last blood draw 24 hours after you receive the study drug (Day 2). These blood draws will be for routine tests, heart, thyroid testing, pharmacokinetic (PK) testing, biomarkers, and genotyping. PK testing measures the amount of study drug in the body at different time points. Genotyping tests are tests that look at pieces of your DNA called genes. These tests will look at some specific genes that may predict how your body may break down certain types of drugs. A small needle called a "heparin lock" may be inserted into a vein to make these multiple blood draws easier.

On Days 8, 15 and 21 of Cycle 1, blood (about 6 tablespoons total) will also be drawn for PK testing. Blood will be drawn a total of 10 times, with the last blood draw about 10 hours after you receive the study drug. You will also have a bone marrow aspiration sample taken to check the status of the disease on Day 21. This sample will be taken between 4-12 hours after you have taken the study drug.

On Day 28 of Cycle 1, you will have the following procedures performed:

- You will have an ECG.

- You will have a physical exam, including measurement of your vital signs.

On Day 1 of Cycles 2-13, you will have the following tests and procedures will be performed:

- Blood (about 1-1/2 tablespoons) and urine will be collected for routine, heart, and thyroid tests.

- You will have a physical exam, including measurement of your vital signs.

- You will have an ECG.

- Women who are able to have children will have a urine pregnancy test. On Day 1 of Cycles 2 and 3 only, blood (less than 1 tablespoon) will be drawn for biomarker tests.

- You will have a MUGA scan.

- If your doctor thinks it is needed, you will have a bone marrow aspiration/biopsy.

Study Visits for CLL or CML participants:

On Day 1 of Cycle 1, you will have the following tests and procedures performed:

- You will have a physical exam, including measurement of your vital signs.

- You will have an ECG.

- Urine will be collected for routine tests.

- You will have a MUGA scan.

- Blood (about 7 tablespoons total) will also be drawn a total of 13 times for routine, heart, thyroid, biomarker, genotyping, and PK testing. The last blood draw will be 24 hours after you receive the study drug (Day 2). A small needle called a "heparin lock" may be inserted into a vein to make these multiple blood draws easier.

- Women who are able to have children will have a urine pregnancy test. If your doctor thinks it is needed, you will have a bone marrow biopsy.

On Day 2 of Cycle 1, blood (about 1 teaspoon) will be drawn 24 hours after your study drug dose.

On Days 21-23 of Cycle 1, you will have an ECG.

On Day 21 of Cycle 1, blood (about 6 tablespoons in total) will be drawn about 8 times for PK testing.

On Days 22 and 23 of Cycle 1, blood (about 1 tablespoon) will be drawn 1 time each day for PK testing.

On Days 8, 15, and 21 of Cycle 1, blood (about 1 tablespoon) will also be drawn for routine, heart, and thyroid tests.

On Day 21 of Cycles 2-3, blood (about 1 tablespoon) will be drawn for biomarkers testing.

During Cycles 2-13, blood (about 1 tablespoon) will be drawn every 2 weeks for routine, heart, and thyroid testing.

On Day 1 of Cycles 2-13, you will have the following tests and procedures performed:

- You will have a physical exam, including measurement of your vital signs.

- You will have an ECG and MUGA scan.

- Blood (about 1 tablespoon) will be drawn for routine, heart, thyroid, and biomarker tests.

- Women who are able to have children will have a urine pregnancy test.

End-of-Study Visit:

Once you are off study, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:

- You will have a physical exam, including measurement of your vital signs.

- You will have an ECG.

- Blood (about 2 tablespoons) will be drawn for routine, heart, thyroid, biomarker, and PK tests.

- Urine will be collected for routine tests.

This is an investigational study. OPB-31121 is not FDA approved or commercially available. At this time, OPB-31121 is only being used in research. Up to 48 patients will take part in this multi-center study.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Leukemia

Intervention

OPB 31121

Location

UT MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:24-0400

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