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

NCT00825227 | Terminated Phase 2 Results

• 1 other identifier: C10953/2036/ON/US
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 29

Brief Summary

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

Conditions

Fatigue; Chemotherapy Side Effects

Keywords

Cancer; Fatigue; Taxanes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of Days With Severe Fatigue, From Patient Responses to the Brief Fatigue Inventory (BFI) Assessment Questionnaire

  Duration of up to 8 weeks total (Screening and Double-Blind)

• Change in the Brief Fatigue Inventory (BFI) Global Score

  Duration of up to 8 weeks total (Screening and Double-Blind)

Study Arms (2)

Patient responses to 150 mg/day armodafinil

ACTIVE COMPARATOR

* 150 mg/day armodafinil * taxane chemotherapy treatment alone or in combination with other agents

Drug: Armodafinil 150 mg/day

Patient responses to placebo

PLACEBO COMPARATOR

* placebo * taxane chemotherapy treatment alone or in combination with other agents

Drug: Placebo,

Interventions

Armodafinil 150 mg/day DRUG

* 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

Patient responses to 150 mg/day armodafinil

Placebo, DRUG

* 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

Patient responses to placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cephalon: lead

Study Sites (29)

Northwest Alabama Cancer Center

Muscle Shoals, Alabama, 35661, United States

Location

Saint Joseph Medical Center

Burbank, California, 91505, United States

Location

Compassionate Cancer Center

Fountain Valley, California, 92708, United States

Location

Wilshire Oncology

La Verne, California, 91750, United States

Location

Compassionate Cancer Center

Riverside, California, 92501, United States

Location

Scripps Cancer Center

San Diego, California, 92123, United States

Location

Washington Cancer Institute

Washington D.C., District of Columbia, 20010, United States

Location

Integrated Community Oncology Network

Jacksonville, Florida, 32256, United States

Location

Southeastern Gynecologic Oncology, LLC

Atlanta, Georgia, 30342, United States

Location

Augusta Oncology

Augusta, Georgia, 30901, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

Summit Cancer Center

Savannah, Georgia, 31405, United States

Location

Ingalls Cancer Research Center

Harvey, Illinois, 60426, United States

Location

Iowa Blood and Cancer Care PLC

Cedar Rapids, Iowa, 52402, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Frederick Memorial Hospital

Frederick, Maryland, 21701, United States

Location

Park Nicollet Institute

Saint Louis Park, Minnesota, 55426, United States

Location

Hematology Oncology Centers of the Northern Rockies

Billings, Montana, 59101, United States

Location

Montana Cancer Institute

Missoula, Montana, 59802, United States

Location

Sparta Cancer Center

Sparta, New Jersey, 17871, United States

Location

Forsyth Regional Cancer Center

Winton, North Carolina, 27103, United States

Location

Cancer Care Associates

Tulsa, Oklahoma, 74136, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Mount Nittany Medical Center

State College, Pennsylvania, 16803, United States

Location

Chester County Hospital

West Chester, Pennsylvania, 19380, United States

Location

Charleston Hematology Oncology, PA

Charleston, South Carolina, 29403, United States

Location

C. Michael Jones

Germantown, Tennessee, 38138, United States

Location

McLeod Cancer and Blood Center

Johnson City, Tennessee, 37604, United States

Location

Cancer Outreach Assoc. / Outreach Clinical Trial Consortium

Abingdon, Virginia, 24211, United States

Location

MeSH Terms

Conditions

Fatigue; Neoplasms

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

This trial was discontinued early after only 10 of 160 planned subjects had been recruited. No efficacy data was analyzed.

Results Point of Contact

• Title: Vice President, Clinical Research
• Organization: Cephalon, Inc.

1-800-896-5855

Study Officials

• Sponsor's Medical Expert

  Cephalon

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2009
• First Posted: January 19, 2009
• Study Start: December 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: February 1, 2010
• Last Updated: November 17, 2017
• Results First Posted: March 13, 2012

Record last verified: 2017-10

Locations

US (29)