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Study to Evaluate the Safety and Efficacy of Armodafinil Treatment for Patients With Fatigue Associated With Taxane Chemotherapy Alone or in Combination With Other Agents
This study is ongoing, but not recruiting participants.
First Received: January 15, 2009   Last Updated: October 7, 2009   History of Changes
Sponsor: Cephalon
Information provided by: Cephalon
ClinicalTrials.gov Identifier: NCT00825227
  Purpose

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


Condition Intervention Phase
Cancer-related Fatigue
Drug: armodafinil and concurrent taxane treatment (alone or in combination with other agents)
Drug: placebo, in addition to taxane treatment (alone or in combination with other agents)
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Cephalon:

Primary Outcome Measures:
  • 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 [ Time Frame: Recorded once daily by the Patient, for up to 8 weeks total (Screening and Double-Blind) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of days with severe fatigue, from patient responses to the Brief Fatigue Inventory (BFI) assessment questionnaire [ Time Frame: Duration of up to 8 weeks total (Screening and Double-Blind) ] [ Designated as safety issue: No ]
  • Change in the Brief Fatigue Inventory (BFI) global score [ Time Frame: Duration of up to 8 weeks total (Screening and Double-Blind) ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: December 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
  • 150 mg/day armodafinil
  • taxane chemotherapy treatment alone or in combination with other agents
Drug: armodafinil and concurrent taxane treatment (alone or in combination with other agents)
  • 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
2: Placebo Comparator
  • placebo
  • taxane chemotherapy treatment alone or in combination with other agents
Drug: placebo, in addition to taxane treatment (alone or in combination with other agents)
  • 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825227

  Show 36 Study Locations
Sponsors and Collaborators
Cephalon
Investigators
Study Director: Sponsor's Medical Expert Cephalon
  More Information

No publications provided

Responsible Party: Cephalon ( Sponsor's Medical Expert )
Study ID Numbers: C10953/2036/ON/US
Study First Received: January 15, 2009
Last Updated: October 7, 2009
ClinicalTrials.gov Identifier: NCT00825227     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Cephalon:
Cancer

Additional relevant MeSH terms:
Signs and Symptoms
Fatigue
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Stimulants
Protective Agents
Neuroprotective Agents
Central Nervous System Agents
Taxane
Pharmacologic Actions
Modafinil

ClinicalTrials.gov processed this record on November 20, 2009