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A Phase 2 Study of AZD6244 in Multiple Myeloma

2014-08-27 03:15:17 | BioPortfolio

Summary

The purpose of this study is to find out what effects, good and/or bad, AZD6244 has on participants and their multiple myeloma. In some types of cancer such as myeloma, a protein called MEK is overactive. This protein is important for cancer cells to be able to reproduce and survive. Because AZD6244 prevents MEK from working properly, it may keep cancer cells from growing and living, so cancer may shrink or its growth may slow down. There is no guarantee, however, that this will happen to the patient's cancer if they join this study.

AZD6244 is an investigational anti-cancer agent that is not approved by the U.S. Food and Drug Administration (FDA) for use in the patient's type of cancer or any other type of cancer.

Description

CYCLE 1:

DAY: Within 14 to 28 days before patients start AZD6244

- Sign Informed Consent Form

- Demographics (name, age, race, etc.)

- Get routine blood tests (and additional research blood sample if patients choose to give it).

- Medical history, smoking history, and current medications

- Physical exam

- Electrocardiogram

- Blood oxygen test

- ECHO or MUGA scan

- Chest X-Ray

- Bone survey (x-rays)

- Bone marrow biopsy and aspirate (and additional research aspirate sample if patients choose to give it)

- 24-hour urine collection

- Random urine sample (and additional research urine sample if patients choose to give it)

- Blood pregnancy test, for women of child-bearing potential

DAY: 1

- Begin taking AZD6244 capsules twice a day, about 12 hours apart. Patients keep taking AZD6244 until the end of study, unless told to stop by the study doctor or study staff.

DAY: 2

- Optional research blood and urine samples (if patients choose to give research blood and urine samples)

- Optional bone marrow procedure for aspirate (if patients choose to give research aspirate sample)

DAY: 8

- Get routine blood tests. Patients bring their study drug capsules and diary with them to study clinic.

DAY: 15

- Get routine blood tests. Patients bring their study drug capsules and diary with them to study clinic.

DAY: 22

- Get routine blood tests. Patients bring their study drug capsules and diary with them to study clinic.

Day 29 = Day 1 of next cycle

- Start the next cycle. Get routine blood tests. Patients bring their study drug capsules and diary with them to study clinic.

CYCLE 2 and FUTURE CYCLES:

DAY: Days 1 to 28 of each cycle

- Blood tests, 24-hour urine collection, review of medications and a physical exam every cycle.

- Keep taking AZD6244 twice a day if patients has no bad side effects and the cancer is not getting worse. Patient to call the study doctor or study staff if they do not know what to do.

DAY: About every 3 months

- Tests to evaluate the status of patient's cancer (any or all of the following: blood tests, urine tests, bone survey, bone marrow biopsy and aspirate).

Study Design

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

Conditions

Multiple Myeloma

Intervention

AZD6244 hydrogen sulfate capsules

Location

H. Lee Moffitt Cancer Center & Research Institute
Tampa
Florida
United States
33612

Status

Recruiting

Source

H. Lee Moffitt Cancer Center and Research Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:17-0400

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Medical and Biotech [MESH] Definitions

A rare, aggressive variant of MULTIPLE MYELOMA characterized by the circulation of excessive PLASMA CELLS in the peripheral blood. It can be a primary manifestation of multiple myeloma or develop as a terminal complication during the disease.

Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.

An envelope of loose gel surrounding a bacterial cell which is associated with the virulence of pathogenic bacteria. Some capsules have a well-defined border, whereas others form a slime layer that trails off into the medium. Most capsules consist of relatively simple polysaccharides but there are some bacteria whose capsules are made of polypeptides.

Derivatives of chondroitin which have a sulfate moiety esterified to the galactosamine moiety of chondroitin. Chondroitin sulfate A, or chondroitin 4-sulfate, and chondroitin sulfate C, or chondroitin 6-sulfate, have the sulfate esterified in the 4- and 6-positions, respectively. Chondroitin sulfate B (beta heparin; DERMATAN SULFATE) is a misnomer and this compound is not a true chondroitin sulfate.

An enzyme that catalyzes the activation of sulfate ions by ATP to form adenosine-5'-phosphosulfate and pyrophosphate. This reaction constitutes the first enzymatic step in sulfate utilization following the uptake of sulfate. EC 2.7.7.4.

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