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| Sponsor: | Eisai Inc. |
|---|---|
| Information provided by (Responsible Party): | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT01007448 |
Purpose
This is a multicenter, randomized, open-label, Phase IV study to assess the efficacy, tolerability and safety of two initial dose levels of bexarotene capsules in patients with refractory cutaneous T-cell lymphoma (CTCL).
| Condition | Intervention | Phase |
|---|---|---|
|
Refractory Cutaneous T-cell Lymphoma |
Drug: bexarotene |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase IV Randomized Study Of Two Dose Levels Of Targretin~ Capsules In Patients With Refractory Cutaneous T-Cell Lymphoma |
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: bexarotene 150mg/m2/day |
Drug: bexarotene
150 mg/m2/day oral bexarotene capsules
Other Name: Targretin
|
| Active Comparator: bexarotene 300 mg/m2/day |
Drug: bexarotene
300 mg/m2/day oral bexarotene capsules
Other Name: Targretin
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
Prior therapy for the treatment of CTCL:
Topical retinoids, nitrogen mustard, BCNU, imiquimod, etc. within two (2) weeks of study entry If antipruritic medication cannot be avoided, antihistamine or antipruritic agents must be administered using a stable dose regimen for at least one (1) week prior to initiation of study drug treatment and throughout the study, unless it is determined that a discontinuation or reduction in dose is indicated. Prior to the enrollment of any patient who will be taking systemic or dermatologically-applied antihistamine or anti-pruritic agent, the investigator must contact Eisai to discuss the need for such agent. Mineral oil, baby oil, and simple moisturizing lotions may be used as emollients. Low- to mid- potency topical corticosteroids are allowed ONLY for patients with erythroderma (stage III/IV CTCL) using a stable dose regimen for at least four (4) weeks prior to study entry. High potency topical corticosteroids and tar baths are NOT permitted.
NOTE: Prior to the enrollment of any patient who will be taking systemic or dermatologically-applied antihistamine or anti-pruritic agent, the investigator must contact the Sponsor to discuss the need for such agent.
Contacts and Locations| Contact: Gail Howard | 201-746-2702 | gail_howard@eisai.com |
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Laura Bradford 205-502-9967 lbradford@uabmc.edu | |
| Principal Investigator: S. Lauren Hughey, MD | |
| United States, Florida | |
| Florida Academic Dermatology Centers | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Annika Grant 305-324-2110 | |
| Principal Investigator: Francisco Kerdel, MD | |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Bridget Bradley 404-778-3084 | |
| Principal Investigator: Sareeta Parker, MD | |
| United States, Illinois | |
| Rush University | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Claudia Riechelmann-Malik 312-563-4001 claudia_riechelmann-malik@rush.edu | |
| Principal Investigator: Michael Tharp, MD | |
| United States, Louisiana | |
| Tulane | Recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| Contact: Edward Coleman 504-988-5135 | |
| Principal Investigator: Erin Boh, MD | |
| United States, Michigan | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Kathryn Keeley 734-936-4075 ktkeeley@med.umich.edu | |
| Principal Investigator: Thomas Anderson, MD | |
| United States, Minnesota | |
| University of Minnesota Medical School | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Rina Farah 612-625-4973 fara0050@umn.edu | |
| Principal Investigator: Kimberly Bohjanen, MD | |
| United States, Missouri | |
| Washington University | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Ann Martin, MD 314-362-8171 | |
| Principal Investigator: Ann Martin, MD | |
| United States, New York | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Brian Poligone, MD 585-276-4673 | |
| Principal Investigator: Brian Poligone, MD | |
| United States, North Carolina | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Annie Tsui 919-668-5610 annie.tsui@duke.edu | |
| Principal Investigator: Elise Olsen, MD | |
| Wake Forest University Health | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| Contact: Julie Fountain 336-716-3775 | |
| Principal Investigator: Alan Fleischer, MD | |
| United States, Ohio | |
| University Hospitals-Case Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Kelly Jeffords 216-983-0661 | |
| Principal Investigator: Neil Korman, MD | |
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Sue McCann 412-864-3681 | |
| Principal Investigator: Larissa Geskin, MD | |
| United States, Tennessee | |
| Vanderbilt | Recruiting |
| Nashville, Tennessee, United States, 37206 | |
| Contact: Brigitta Brannon 615-936-1133 brigitta.brannon@vanderbilt.edu | |
| Principal Investigator: John Zic, MD | |
| United States, Texas | |
| University of Texas Southwestern Medical Center | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Mia Ashe-Randolph 214-645-8968 | |
| Principal Investigator: Amit Pandya, MD | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Carol Wilson 713-563-4655 clwilson@mdanderson.org | |
| Principal Investigator: Madeleine Duvic, MD | |
| United States, Utah | |
| Huntsman Cancer Institute At the University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84112 | |
| Contact: Chris Hamatake 801-587-7604 | |
| Principal Investigator: Glen Bowen, MD | |
| Study Director: | Gary Palmer, MD | Eisai Inc. |
More Information
| Responsible Party: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT01007448 History of Changes |
| Other Study ID Numbers: | E7273-G000-401 |
| Study First Received: | November 3, 2009 |
| Last Updated: | January 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
CTCL bexarotene Targretin Refractory Cutaneous T-cell Lymphoma |
cutaneous T-cell Lymphoma MF Mycoses fungoides |
|
Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Bexarotene Anticarcinogenic Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |