A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab
NCT ID: NCT01307267
Last Updated: 2020-03-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
190 participants
INTERVENTIONAL
2011-06-21
2019-02-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Portion A
PF-05082566 single agent in patients with advanced cancer
PF-05082566
Intravenous, Dose escalation, once per month
Portion B
PF-05082566 in combination with rituximab in patients with Non-Hodgkin's Lymphoma
rituximab
Intravenous, 375 mg/m2, once per week for 4 weeks
PF-05082566
IV, Dose escalation, once per month
Interventions
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PF-05082566
Intravenous, Dose escalation, once per month
rituximab
Intravenous, 375 mg/m2, once per week for 4 weeks
PF-05082566
IV, Dose escalation, once per month
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Portion B: Histological confirmed relapsed or refractory CD20 positive NHL for which no curative therapy is available. Patients enrolled in the expansion cohort must have archival tissue available, sampled within 6 months of study entry. The Expansion cohort includes patients with FL or DLBCL with relapsed or refractory disease.
* Measurable disease with at least one extranodal tumor mass \>1.0 cm in the greatest transverse diameter (GTD) or in the case of malignant lymph nodes \>1.5 cm in the GTD.
* ECOG performance status of ≤ 1.
* Adequate bone marrow function, for Portion A: absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥100 x 109/L, hemoglobin \>9.0 g/dL. For Portion B: ANC ≥ 1.0 x 109/L, platelet count ≥ 75 x 109/L, and hemoglobin ≥ 8.0 g/dL. In both cases, patients must be transfusion independent at least 14 days prior to screening.
* Serum creatinine ≤ 2 x ULN or estimated creatinine clearance ≥ 50 ml/min.
* Total serum bilirubin ≤ 1.5 x ULN unless the patient has documented Gilbert syndrome and AST and ALT ≤ 2.5 x ULN.
Exclusion Criteria
* Prior allogeneic hematopoietic stem cell transplant.
* Immunosuppressive regimens involving systemic corticosteroids within 14 days before the first dose of study treatment.
* Therapeutic or experimental monoclonal antibodies within 28 day or prior radiation therapy within 14 days of the first dose of study drug.
* Autoimmune disorders and other diseases that compromise or impair the immune system.
* Unstable or serious concurrent medical conditions in the previous 6 months.
* Prior therapy with any anti CD137 monoclonal antibody.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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City of Hope
Duarte, California, United States
UC San Diego Moores Cancer Center-Investigational Drug Services
La Jolla, California, United States
UC San Diego Medical Center-La Jolla (Jacobs Medical Center/Thornton Hospital)
La Jolla, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Research Administration Office: Clinical Research Unit
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles, California, United States
UCLA Bowyer Clinic
Los Angeles, California, United States
UCLA Hematology-Oncology Clinic
Los Angeles, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Stanford University Medical Center
Palo Alto, California, United States
UC San Diego Medical Center - Hillcrest
San Diego, California, United States
Santa Monica UCLA Hematology & Oncology Clinic
Santa Monica, California, United States
Stanford University Medical Center
Stanford, California, United States
Georgetown University Medical Center Department of Pharmacy, Research
Washington D.C., District of Columbia, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
The Emory Clinic, Building A
Atlanta, Georgia, United States
The Emory Clinic
Atlanta, Georgia, United States
Winship Cancer Institute
Atlanta, Georgia, United States
Brigham and Woman's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Siteman Cancer Center - St. Peters
City of Saint Peters, Missouri, United States
Siteman Cancer Center-West County
Creve Coeur, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Washington University Infusion Center Pharmacy
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Siteman Cancer Center- South County
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
The University of Texas - M.D. Anderson Cancer Center
Houston, Texas, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Centre d'investigation clinique
Rennes, , France
Az. Ospedaliera-Univer. di Bologna Policlinico S. Orsola Malpighi
Bologna, BO, Italy
Ospedale San Raffaele di Milano
Milan, MI, Italy
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Akita University Hospital
Akita, , Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Tokyo, , Japan
Countries
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References
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Gopal AK, Levy R, Houot R, Patel SP, Popplewell L, Jacobson C, Mu XJ, Deng S, Ching KA, Chen Y, Davis CB, Huang B, Fly KD, Thall A, Woolfson A, Bartlett NL. First-in-Human Study of Utomilumab, a 4-1BB/CD137 Agonist, in Combination with Rituximab in Patients with Follicular and Other CD20+ Non-Hodgkin Lymphomas. Clin Cancer Res. 2020 Jun 1;26(11):2524-2534. doi: 10.1158/1078-0432.CCR-19-2973. Epub 2020 Mar 6.
Segal NH, He AR, Doi T, Levy R, Bhatia S, Pishvaian MJ, Cesari R, Chen Y, Davis CB, Huang B, Thall AD, Gopal AK. Phase I Study of Single-Agent Utomilumab (PF-05082566), a 4-1BB/CD137 Agonist, in Patients with Advanced Cancer. Clin Cancer Res. 2018 Apr 15;24(8):1816-1823. doi: 10.1158/1078-0432.CCR-17-1922. Epub 2018 Mar 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2011-002799-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1641001
Identifier Type: -
Identifier Source: org_study_id
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