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Clinical Trials (PDQ®)

Single Agent Ofatumumab Vs. Single Agent Rituximab in Follicular Lymphoma Relapsed After Rituximab-Containing Therapy

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActive18 and overPharmaceutical / Industry113676
NCT01200589

Trial Description

Summary

This is a multi-center, parallel, active comparator controlled, open-label, randomized (1:1) phase III study of single agent ofatumumab compared to single agent rituximab in subjects with rituximab-sensitive grade 1, 2, and 3A follicular lymphoma that has relapsed at least 6 months after completing treatment with single agent rituximab or a rituximab-containing regimen. Subjects must have attained a Complete Response or Partial Response to their last prior rituximab containing therapy lasting at least six months beyond the end of rituximab therapy. Subjects will receive four weekly doses of single agent ofatumumab (1000 mg) or rituximab (375 mg/m2), followed by ofatumumab (1000 mg) or rituximab (375 mg/m2) every 2 months for four additional doses. Therefore, subjects will receive a total of eight doses of anti-CD20 antibody over 9 months. Subjects will be evaluated for response after completion of the first four doses of therapy, after six doses of therapy, and after completion of study therapy. Subjects will be followed until the end of the designated follow-up period (total study duration of 200 weeks) or until they meet the withdrawal criteria.

Eligibility Criteria

Inclusion Criteria:

1. Follicular lymphoma (FL); grades 1, 2 and 3A, defined according to World Health Organization guidelines.

2. Rituximab-sensitive FL, defined as a partial or complete response to treatment with rituximab or a rituximab-containing regimen lasting at least 6 months following completion of the last rituximab treatment.

3. Relapse or disease progression following response to prior rituximab-based therapy, as defined by 2007 Revised Response Criteria for Malignant Lymphoma criteria, which requires therapy.

4. Radiographically measurable disease, defined as at least one clearly demarcated lesion with a largest diameter ≥ 2.0 cm by CT scan imaging.

5. ECOG Performance Status of 0, 1, or 2.

6. Age ≥ 18 years.

7. Life expectancy of at least 6 months in the opinion of the investigator.

8. The patient or their legally acceptable representative must be capable of giving written informed consent prior to performing any study-specific tests or procedures.

9. All prior treatment related non-hematologic toxicities (with the exception of alopecia) must have resolved to CTCAE (Version 4.0) ≤ Grade 2 at the time of randomization.

French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Exclusion Criteria:

1. Previous treatment with ofatumumab.

2. Previous radioimmunotherapy (RIT) within 6 months of randomization. Patients who have received previous RIT must have attained a partial or complete response lasting at least 6 months, and must have recovered from any hematologic or other toxicity.

3. Previous autologous stem cell transplantation within 6 months of randomization.

4. Previous allogeneic stem cell transplantation.

5. Previous anti-lymphoma monoclonal antibody therapy (excluding rituximab), chemotherapy, glucocorticoid, or other systemic therapy for lymphoma within 3 months of randomization.

6. Current or previous participation in another interventional clinical study within 4 weeks of randomization.

7. Current or previous other malignancy within 2 years of randomization. Subjects who have been free of malignancy for at least 2 years, or have a history of completely resected non-melanoma skin cancer or successfully treated carcinoma in situ, are eligible.

8. Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis, active Hepatitis C, and known HIV disease.

9. Clinically significant cardiac disease as judged by the investigator including unstable angina, acute myocardial infarction within 6 months of randomization, congestive heart failure, and arrhythmia requiring therapy.

10. Other significant concurrent, uncontrolled medical conditions including, but not limited to, renal, hepatic, autoimmune, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which, in the investigator's opinion, will impact study participation.

11. Screening laboratory values:

1. Neutrophils < 1.5 x 109/L (unless due to FL involvement of the bone marrow).

2. Platelets < 50 x 109/L (unless due to FL involvement of the bone marrow).

3. ALT or AST > 2xULN, alkaline phosphatase and bilirubin > 1.5xULN (isolated predominantly indirect hyperbilirubinemia due to Gilbert's syndrome is acceptable for inclusion)

12. Known or suspected inability to fully comply with study protocol

a. Lactating women. b. Women with a positive pregnancy test at study entry c. Men with partners of childbearing potential and women of childbearing potential who are not willing to use adequate contraception from study entry through one year following last treatment dose.

14. Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones).

15. Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.

Trial Contact Information

Trial Lead Organizations/Sponsors

GlaxoSmithkline

GSK Clinical TrialsStudy Director

US GSK Clinical Trials Call CenterPh: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com

Trial Sites

U.S.A.
Arizona
  Gilbert
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
California
  Greenbrae
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Monterey
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Rancho Mirage
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  San Diego
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Florida
  Lakeland
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Pembroke Pines
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Port St. Lucie
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  West Palm Beach
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Georgia
  Macon
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Marietta
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Illinois
  Peoria
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Skokie
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Iowa
  Ames
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Louisiana
  Shreveport
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Michigan
  Grand Rapids
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Missouri
  Kansas City
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Springfield
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Nebraska
  Lincoln
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
New York
  Lake Success
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Mount Kisco
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
North Carolina
  Greensboro
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Ohio
  Canton
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Pennsylvania
  Danville
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Willow Grove
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Texas
  Fort Sam Houston
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Utah
  Salt Lake City
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Virginia
  Fredericksburg
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Washington
  Kennewick
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Seattle
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Spokane
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Belgium
  Antwerpen
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Brugge
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Brussels
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Kortrijk
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Leuven
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Wilrijk
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Brazil
  Curitiba
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Porto Alegre
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Rio de Janeiro
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  São Paulo
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Sao Paulo
  Jau
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Canada
  Moncton
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Ontario
  Kitchener
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Quebec
  Québec
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
China
  Beijing
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Guangzhou
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Hangzhou
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Shanghai
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Czech Republic
  Brno
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Hradec Kralove
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Praha 2
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
France
  Boulogne sur Mer Cedex
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Clermont-Ferrand Cedex 1
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  La Roche sur Yon Cedex 9
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Le Mans
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Montpellier cedex 5
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Pessac cedex
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Hungary
  Budapest
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Debrecen
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Gyor
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Szeged
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Japan
  Aichi
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Kyoto
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Miyagi
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Nagasaki
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Saitama
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Tochigi
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Tokyo
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Peru
  Lima
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Miraflores
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  San Isidro
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Puerto Rico
  San Juan
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Republic of Bulgaria
  Plovdiv
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Sofia
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Varna
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Republic of Korea
  Busan
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Seoul
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Republic of South Africa
  Athlone Park, Amanzimtoti
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Parktown
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Port Elizabeth
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Saxonwold, Johannesburg
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
Ukraine
  Kyiv
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Lviv
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com
  Makiivka
 GSK Investigational Site
 US GSK Clinical Trials Call Center Ph: 877-379-3718
  Email: GSKClinicalSupportHD@gsk.com
 EU GSK Clinical Trials Call Center Ph: +44 (0) 20 8990 4466
  Email: GSKClinicalSupportHD@gsk.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01200589
ClinicalTrials.gov processed this data on December 17, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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