|
|
View Clinical Trial (Medical Research Study)
|
A Phase 1/2 Study of ARRY-520 in Patients With Relapsed or Refractory Multiple Myeloma - NCT00821249-30322 (Clinical Trial 263389)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy263389.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Atlanta |
|
State:
|
|
GA |
| Zip Code: |
|
30322 |
| Conditions: |
|
Multiple Myeloma - Plasma Cell Leukemia |
| Purpose: |
|
ARRY-520 is designed to prevent cancer cells from reproducing. By preventing the tumor cells
from reproducing, ARRY-520 may slow the spread of the cancer cells and may cause them to
die. ARRAY-520-212 is a study meant for patients with relapsed or refractory multiple
myeloma or plasma cell leukemia, who have already received at least two previous treatments.
Prior treatments should include bortezomib and an immunomodulatory agent, such as
thalidomide and/or lenalidomide, unless the patients were not eligible or refused to receive
those treatments. In the first part of this study, patients will receive increasing doses of
a novel kinesin spindle protein inhibitor (KSP inhibitor) in order to achieve the highest
dose possible that will not cause unacceptable side effects. In the second part of the
study, a larger group of patients will receive the best dose determined from the first part
of the study. Both groups of patients will be followed to see what side effects ARRY-520
causes and to see what effectiveness it has, if any in treating the cancer.
|
| Study summary: |
|
|
| Criteria: |
|
Inclusion Criteria:
- Confirmed relapsed or refractory MM or PCL. Patients should have received at least
two prior treatment regimens. Prior treatment must have included bortezomib and an
immunomodulatory agent (e.g., thalidomide and/or lenalidomide), unless patients were
not eligible or refused to receive these treatments. The disease should have
progressed during or after the last prior treatment regimen.
- Measurable MM disease, defined as one of the following:
- A monoclonal immunoglobulin (Ig) concentration on serum electrophoresis of ≥ 1.0
g/dL for an IgG myeloma, 0.5 g/dL for an IgA myeloma, and 0.1 g/dL for an IgD
myeloma;
- Measurable urinary light chain secretion by quantitative analysis of ≥ 200 mg/24
hours;
- Involved serum free light chain (FLC) level ≥ 10 mg/dL, provided the serum FLC
ratio is abnormal;
- Patients with oligo- or non-secretory disease must have bone marrow involvement
with at least 30% plasmacytosis on aspiration.
- Male or female, ≥ 18 years of age at time of signing consent.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Adequate hematology laboratory values without transfusion support within two weeks of
screening:
- Hemoglobin ≥ 8 g/dL;
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L;
- Platelets ≥ 75 x 109/L.
- Adequate liver and renal function:
- Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT)
and/or alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT)
≤ 2.5 x the upper limit of normal (ULN);
- Bilirubin < 1.5 mg/dL;
- Serum creatinine ≤ 2.5 mg/dL, and a calculated creatinine clearance of at least
50 mL/min (using the Cockcroft and Gault method).
- If patient is female and of childbearing potential, she must have a negative serum
beta human chorionic gonadotropin (ß HCG) test.
- Male patients and female patients of childbearing potential must agree to use an
effective method of contraception per institutional standard.
- Signed informed consent prior to initiation of any study-related procedures that are
not considered standard of care.
Exclusion Criteria:
- Primary amyloidosis.
- Concomitant malignancies or previous malignancies with less than a three-year disease
free interval at the time of enrollment. Patients with adequately resected basal or
squamous cell carcinoma of the skin, carcinoma in situ of the cervix or Stage A low
grade prostate cancer may enroll irrespective of the time of diagnosis.
- Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to
first dose of study drug.
- Treatment with an investigational product or device within 28 days of initiating
study drug.
- Cytotoxic therapy or monoclonal antibodies within 21 days prior to first dose of
study drug.
- Radiotherapy within 21 days prior to first dose of study drug. However, if the
radiation portal covered ≤ 5% of the bone marrow reserve, the patient may be enrolled
irrespective of the end date of radiotherapy.
- Major surgery within two weeks prior to first dose of study drug.
- Corticosteroid doses > 10 mg/day within two weeks prior to first dose of study drug.
- Any serious medical or psychiatric disorder that would interfere with patient safety
or informed consent.
- Any severe concurrent disease or condition (including active systemic infection,
symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia),
which, in the judgment of the Investigator, would make the patient inappropriate for
study participation.
- Known positive serology for the Human Immunodeficiency Virus (HIV), Hepatitis B
and/or active Hepatitis C. |
|
|
|
| Study is available at: |
|
Emory University, Winship Cancer Institute
Atlanta, GA 30322
United States
Primary Contact:
Renee Smith, CRC
Email: rgsmith@emory.edu
Phone: 404-778-5144 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 16, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|
|
|
|