|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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 |
| 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
|
Drug: armodafinil and concurrent taxane treatment (alone or in combination with other agents)
|
2: Placebo Comparator
|
Drug: placebo, in addition to taxane treatment (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 |
Key Inclusion Criteria:
Key Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Northwest Alabama Cancer Center | |
| Muscle Shoals, Alabama, United States, 35661 | |
| United States, California | |
| Wilshire Oncology | |
| La Verne, California, United States, 91750 | |
| Saint Joseph Medical Center | |
| Burbank, California, United States, 91505 | |
| Scripps Cancer Center | |
| San Diego, California, United States, 92123 | |
| Compassionate Cancer Center | |
| Riverside, California, United States, 92501 | |
| Compassionate Cancer Center | |
| Fountain Valley, California, United States, 92708 | |
| United States, Connecticut | |
| Davis, Posteraro and Wassner | |
| Manchester, Connecticut, United States, 06040 | |
| United States, District of Columbia | |
| Washington Cancer Institute | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Integrated Community Oncology Network | |
| Jacksonville, Florida, United States, 32256 | |
| Gulf Coast Oncology Association | |
| St Petersburg, Florida, United States, 33705 | |
| United States, Georgia | |
| Summit Cancer Center | |
| Savannah, Georgia, United States, 31405 | |
| Augusta Oncology | |
| Augusta, Georgia, United States, 30901 | |
| Southeastern Gynecologic Oncology, LLC | |
| Atlanta, Georgia, United States, 30342 | |
| Medical College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| United States, Illinois | |
| Ingalls Cancer Research Center | |
| Harvey, Illinois, United States, 60426 | |
| Oncology Hematology Associates of Central Illinois P. C. | |
| Peoria, Illinois, United States, 61615 | |
| United States, Indiana | |
| Cancer Care Center, Inc | |
| New Albany, Indiana, United States, 47150 | |
| United States, Iowa | |
| Iowa Blood and Cancer Care PLC | |
| Cedar Rapids, Iowa, United States, 52402 | |
| United States, Louisiana | |
| Southwest Oncology Associates | |
| Lafayette, Louisiana, United States, 70503 | |
| United States, Maryland | |
| Frederick Memorial Hospital | |
| Frederick, Maryland, United States, 21701 | |
| Center for Cancer and Blood Disorders | |
| Bethesda, Maryland, United States, 20817 | |
| United States, Minnesota | |
| Park Nicollet Institute | |
| St Louis Park, Minnesota, United States, 55426 | |
| United States, Montana | |
| Montana Cancer Institute | |
| Missoula, Montana, United States, 59802 | |
| Hematology Oncology Centers of the Northern Rockies | |
| Billings, Montana, United States, 59101 | |
| United States, New Jersey | |
| Sparta Cancer Center | |
| Sparta, New Jersey, United States, 17871 | |
| United States, North Carolina | |
| Forsyth Regional Cancer Center | |
| Winton, North Carolina, United States, 27103 | |
| United States, Oklahoma | |
| Cancer Care Associates | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Pennsylvania | |
| Chester County Hospital | |
| West Chester, Pennsylvania, United States, 19380 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822 | |
| Mount Nittany Medical Center | |
| State College, Pennsylvania, United States, 16803 | |
| Geisinger Wyoming Valley Medical Center | |
| Wilkes-Barre, Pennsylvania, United States, 18702 | |
| United States, South Carolina | |
| Associated Medical Specialists | |
| Myrtle Beach, South Carolina, United States, 29572 | |
| Charleston Hematology Oncology, PA | |
| Charleston, South Carolina, United States, 29403 | |
| United States, Tennessee | |
| McLeod Cancer and Blood Center | |
| Johnson City, Tennessee, United States, 37604 | |
| C. Michael Jones | |
| Germantown, Tennessee, United States, 38138 | |
| United States, Virginia | |
| Cancer Outreach Assoc. / Outreach Clinical Trial Consortium | |
| Abingdon, Virginia, United States, 24211 | |
| Study Director: | Sponsor's Medical Expert | Cephalon |
More Information
| 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 |
|
Cancer |
|
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 |