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

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

Study Overview

• Status: Terminated
• Conditions: Fatigue; Chemotherapy Side Effects
• Intervention / Treatment: Drug: Armodafinil 150 mg/day; Drug: Placebo,

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Muscle Shoals, Alabama, United States, 35661
      • Northwest Alabama Cancer Center
  • California
    • Burbank, California, United States, 91505
      • Saint Joseph Medical Center
    • Fountain Valley, California, United States, 92708
      • Compassionate Cancer Center
    • La Verne, California, United States, 91750
      • Wilshire Oncology
    • Riverside, California, United States, 92501
      • Compassionate Cancer Center
    • San Diego, California, United States, 92123
      • Scripps Cancer Center
  • District of Columbia
    • Washington, D.C., District of Columbia, United States, 20010
      • Washington Cancer Institute
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Integrated Community Oncology Network
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Southeastern Gynecologic Oncology, LLC
    • Augusta, Georgia, United States, 30912
      • Medical College of Georgia
    • Augusta, Georgia, United States, 30901
      • Augusta Oncology
    • Savannah, Georgia, United States, 31405
      • Summit Cancer Center
  • Illinois
    • Harvey, Illinois, United States, 60426
      • Ingalls Cancer Research Center
  • Iowa
    • Cedar Rapids, Iowa, United States, 52402
      • Iowa Blood and Cancer Care PLC
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Center for Cancer and Blood Disorders
    • Frederick, Maryland, United States, 21701
      • Frederick Memorial Hospital
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55426
      • Park Nicollet Institute
  • Montana
    • Billings, Montana, United States, 59101
      • Hematology Oncology Centers of the Northern Rockies
    • Missoula, Montana, United States, 59802
      • Montana Cancer Institute
  • New Jersey
    • Sparta, New Jersey, United States, 17871
      • Sparta Cancer Center
  • North Carolina
    • Winton, North Carolina, United States, 27103
      • Forsyth Regional Cancer Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Cancer Care Associates
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • State College, Pennsylvania, United States, 16803
      • Mount Nittany Medical Center
    • West Chester, Pennsylvania, United States, 19380
      • Chester County Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • Charleston Hematology Oncology, PA
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • C. Michael Jones
    • Johnson City, Tennessee, United States, 37604
      • McLeod Cancer and Blood Center
  • Virginia
    • Abingdon, Virginia, United States, 24211
      • Cancer Outreach Assoc. / Outreach Clinical Trial Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patient responses to 150 mg/day armodafinil; 150 mg/day armodafinil; taxane chemotherapy treatment alone or in combination with other agents	Drug: Armodafinil 150 mg/day; 150 mg/day armodafinil; concurrent with one cycle of taxane chemotherapy alone or in combination with other agents; patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents
Placebo Comparator: Patient responses to placebo; placebo; taxane chemotherapy treatment alone or in combination with other agents	Drug: Placebo,; placebo; concurrent with one cycle of taxane chemotherapy alone or in combination with other agents; patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Over Time in the Patient's Daily Ratings of Their Worst Fatigue Severity (as Assessed for the Past 24 Hours), Obtained From the Patient's Responses on the Brief Fatigue Inventory (BFI) Questionnaire	Brief Fatigue Inventory (BFI) measures fatigue severity and impact on function on 11-point scale (0-10). Primary outcome measure is average daily rating of BFI question 3: worst level of fatigue over past 24-hours. 0 = no fatigue, 10 = worst imaginable. Study was terminated after only a few patients enrolled and therefore efficacy results were not analyzed and are not reported. Maximum response (most fatigue) would score 10 and minimum response (least fatigue) would score 0. Change was measured from Baseline (cycle 1) to cycle 2. Changes based on matching baseline period with cycle 2 period.	Recorded once daily by the Patient, for up to 8 weeks total (Screening and Double-Blind)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Days With Severe Fatigue, From Patient Responses to the Brief Fatigue Inventory (BFI) Assessment Questionnaire	The Brief Fatigue Inventory (BFI) measures severity of fatigue and impact of fatigue on daily functioning in past 24 hours. It is a 9-item questionnaire that uses an 11-point scale (0-10) to assess severity. 0 represents no fatigue, 10 represents as bad as you can imagine. The percentage of days with severe fatigue as assessed by the BFI was to be assessed. Study was terminated as a result of a business decision after only a few patients were enrolled and therefore efficacy results were not analyzed and are not reported.	Duration of up to 8 weeks total (Screening and Double-Blind)
Change in the Brief Fatigue Inventory (BFI) Global Score	The Brief Fatigue Inventory (BFI) measures severity of fatigue and impact of fatigue on daily functioning in past 24 hours. It is a 9-item questionnaire that uses an 11-point scale (0-10) to assess severity. Question 3 asks for worst level of fatigue during past 24-hours. 0 represents no fatigue, 10 represents as bad as you can imagine. The global score (0 to 90) determined by adding each item was to be assessed. Study was terminated as a result of a business decision after only a few patients were enrolled and therefore efficacy results were not analyzed and are not reported.	Duration of up to 8 weeks total (Screening and Double-Blind)

Collaborators and Investigators

• Sponsor: Cephalon

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: January 15, 2009
• First Submitted That Met QC Criteria: January 16, 2009
• First Posted (Estimate): January 19, 2009

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: October 12, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Cancer; Fatigue; Taxanes
• Additional Relevant MeSH Terms: Fatigue; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Central Nervous System Stimulants; Wakefulness-Promoting Agents; Modafinil
• Other Study ID Numbers: C10953/2036/ON/US