Safety and Efficacy of Armodafinil for Fatigue Associated With Taxanes Alone or in Combination With Other Agents



Status:Terminated
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:11/18/2017
Start Date:December 2008
End Date:February 2010

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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Armodafinil Treatment (150 mg/Day) for Patients With Fatigue Associated With Taxane Chemotherapy Alone or in Combination With Other Agents

Evaluate the Safety and Efficacy of Armodafinil Treatment for Patients With Fatigue
Associated With Taxane Chemotherapy Alone or in Combination With Other Agents

The primary objective of study was to determine whether armodafinil treatment at a dose of
150 mg/day is more effective than placebo treatment in reducing fatigue in patients receiving
taxane chemotherapy alone or in combination with other agents by comparing the change from
Screening cycle to treatment cycle (cycle 2) in the patient's average daily rating of their
worst fatigue severity during the past 24 hours. In addition, the change in the percentage of
days with severe fatigue and the mean Brief Fatigue Inventory scores were to be recorded.

Key Inclusion Criteria:

- The patient has cancer and is receiving, or is scheduled to receive, taxane
chemotherapy (paclitaxel, docetaxel, or albumin-bound paclitaxel), either alone or in
combination with other agents.

- The patient experiences an average score of 6 or greater for the daily worst fatigue
severity assessment during screening.

- The patient has a life expectancy of at least 6 months.

- The patient is able to use the wrist actigraphy device or provide written
documentation during the screening period.

- The patient has stable hemoglobin (≥10 g/dL) throughout the screening period.

- Women of childbearing potential (not surgically sterile or 2 years postmenopausal)
must use a medically accepted method of contraception (including abstinence) and must
agree to continue use of this method for the duration of the study and for 30 days
after participation in the study.

- Men not surgically sterile or who are capable of producing offspring must practice
abstinence or use a barrier method of birth control, and must agree to continue use of
this method for the duration of the study and for 30 days after participation in the
study.

- The patient has adequate hepatic and renal function.

- The patient meets the proposed diagnostic criteria for cancer-related fatigue as
included in the International Classifications of Disease, Tenth Revision, Clinical
Modification (ICD-10-CM).

- If the patient is taking any other chronic medication which may affect fatigue (e.g.,
antidepressants, anxiolytics, opioid analgesics), the dose has been stable for at
least 4 weeks prior to screening and is expected to remain stable during the study.

Key Exclusion Criteria:

- The patient has any untreated reversible medical condition which may cause fatigue
(e.g., metabolic disturbance, infection, endocrine abnormalities).

- The patient has received concurrent stimulant medication (e.g., dextroamphetamine or
methylphenidate) during the screening period or double-blind treatment period.

- The patient has received concurrent modafinil during the screening period or
double-blind treatment period.

- The patient has any delay in chemotherapy treatment such that the screening period
extends beyond 6 weeks.

- The patient has known central nervous system (CNS) involvement by metastatic cancer.

- The patient is receiving concurrent radiation therapy (except for palliative
radiation) or treatment with another investigational agent.

- The patient has any serious, uncontrolled, non-malignant medical or psychiatric
disorder that could impair the conduct of the study or the safety of the patient.

- The patient is pregnant or lactating.

- The patient has known HIV positivity.

- The patient has nausea and vomiting or any gastrointestinal disorder that is severe
enough to interfere with study drug absorption in the opinion of the investigator.

- The patient has uncontrolled pain.

- The patient has a known hypersensitivity to the study medication or ingredients of the
study medication.
We found this trial at
29
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Cedar Rapids, Iowa 52402
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Cedar Rapids, IA
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873
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Abingdon, VA
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Atlanta, Georgia 30342
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Atlanta, GA
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1303 D'Antignac Street
Augusta, Georgia 30901
936
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Augusta, GA
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598 Telfair Street
Augusta, Georgia 30912
937
mi
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Augusta, GA
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6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
1121
mi
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Bethesda, MD
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783
mi
from
Billings, MT
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Burbank, California 91505
1169
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Burbank, CA
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Charleston, South Carolina 29403
1062
mi
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Charleston, SC
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
1151
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Danville, PA
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11180 Warner Avenue
Fountain Valley, California 92708
1159
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Fountain Valley, CA
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Frederick, Maryland 21701
1107
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Frederick, MD
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Germantown, Tennessee 38138
481
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Germantown, TN
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Harvey, Illinois 60426
601
mi
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Harvey, IL
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Jacksonville, Florida 32256
1055
mi
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Jacksonville, FL
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Johnson City, Tennessee 37604
856
mi
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Johnson City, TN
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1910 Royalty Drive
La Verne, California 91750
1140
mi
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La Verne, CA
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Missoula, Montana 59802
1036
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Missoula, MT
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Muscle Shoals, Alabama 35661
604
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Muscle Shoals, AL
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4500 Brockton Avenue
Riverside, California 92501
1123
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Riverside, CA
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Saint Louis Park, Minnesota 55416
548
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Saint Louis Park, MN
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San Diego, California 92121
1140
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San Diego, CA
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225 Candler Drive
Savannah, Georgia 31405
1024
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Savannah, GA
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Sparta, New Jersey 07871
1254
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Sparta, NJ
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1800 E Park Ave
State College, Pennsylvania 16803
(814) 231-7000
Mount Nittany Medical Center Mount Nittany Medical Center is a 260-bed acute care facility offering...
1083
mi
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State College, PA
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Tulsa, Oklahoma 74136
155
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Tulsa, OK
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110 Irving Street Northwest
Washington, D.C., District of Columbia 20010
1128
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Washington, D.C.,
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West Chester, Pennsylvania 19380
1202
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West Chester, PA
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3333 Silas Creek Parkway
Winton, North Carolina 27103
973
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Winton, NC
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