Safety and Efficacy of Armodafinil for Fatigue Associated With Taxanes 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.