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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00825227
• Other study ID #: C10953/2036/ON/US
• Status: Terminated
• Phase: Phase 2
• First received: January 15, 2009
• Last updated: October 12, 2017
• Start date: December 2008
• Est. completion date: February 2010

Study information

• Verified date: October 2017
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy Side Effects
• Fatigue

Intervention

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,
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

Locations

Country	Name	City	State
United States	Cancer Outreach Assoc. / Outreach Clinical Trial Consortium	Abingdon	Virginia
United States	Southeastern Gynecologic Oncology, LLC	Atlanta	Georgia
United States	Augusta Oncology	Augusta	Georgia
United States	Medical College of Georgia	Augusta	Georgia
United States	Center for Cancer and Blood Disorders	Bethesda	Maryland
United States	Hematology Oncology Centers of the Northern Rockies	Billings	Montana
United States	Saint Joseph Medical Center	Burbank	California
United States	Iowa Blood and Cancer Care PLC	Cedar Rapids	Iowa
United States	Charleston Hematology Oncology, PA	Charleston	South Carolina
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Compassionate Cancer Center	Fountain Valley	California
United States	Frederick Memorial Hospital	Frederick	Maryland
United States	C. Michael Jones	Germantown	Tennessee
United States	Ingalls Cancer Research Center	Harvey	Illinois
United States	Integrated Community Oncology Network	Jacksonville	Florida
United States	McLeod Cancer and Blood Center	Johnson City	Tennessee
United States	Wilshire Oncology	La Verne	California
United States	Montana Cancer Institute	Missoula	Montana
United States	Northwest Alabama Cancer Center	Muscle Shoals	Alabama
United States	Compassionate Cancer Center	Riverside	California
United States	Park Nicollet Institute	Saint Louis Park	Minnesota
United States	Scripps Cancer Center	San Diego	California
United States	Summit Cancer Center	Savannah	Georgia
United States	Sparta Cancer Center	Sparta	New Jersey
United States	Mount Nittany Medical Center	State College	Pennsylvania
United States	Cancer Care Associates	Tulsa	Oklahoma
United States	Washington Cancer Institute	Washington, D.C.	District of Columbia
United States	Chester County Hospital	West Chester	Pennsylvania
United States	Forsyth Regional Cancer Center	Winton	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)