A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab

Part of paid clinical trials in Duarte, California.

Sponsor
Pfizer
Study ID
NCT01307267
Phase
PHASE1
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Carcinoma, Squamous Cell of Head and Neck
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Malignant Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PF-05082566 — DRUG
    Intravenous, Dose escalation, once per month
  • rituximab — DRUG
    Intravenous, 375 mg/m2, once per week for 4 weeks
  • PF-05082566 — DRUG
    IV, Dose escalation, once per month

Study Details

A study of PF-05082566, a 4-1BB agonist monoclonal antibody (mAb), in patients with solid tumors or b-cell lymphomas, and in combination with rituximab in patients with CD20 positive Non-Hodgkin's Lymphoma (NHL).

Key Dates

Start date
Jun 21, 2011
Status verified
Mar 2020
Primary completion
Feb 20, 2019
Completion
Feb 20, 2019

Study Design

Enrollment
190 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Portion A
    PF-05082566 single agent in patients with advanced cancer
  • Experimental: Portion B
    PF-05082566 in combination with rituximab in patients with Non-Hodgkin's Lymphoma

Primary Outcome Measure

Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A [ Time Frame: Cycle 1 Day 1 to Cycle 2 Day 29 in Portion A (up to 57 days, each cycle = 28 days) ]

Locations (35)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
UC San Diego Medical Center-La Jolla (Jacobs Medical Center/Thornton Hospital)La JollaCalifornia92037-
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
UC San Diego Moores Cancer Center-Investigational Drug ServicesLa JollaCalifornia92037-0845-
Research Administration Office: Clinical Research UnitLos AngelesCalifornia90095-
Ronald Reagan UCLA Medical Center, Drug Information CenterLos AngelesCalifornia90095-
UCLA Bowyer ClinicLos AngelesCalifornia90095-
UCLA Hematology-Oncology ClinicLos AngelesCalifornia90095-
Stanford University Medical CenterPalo AltoCalifornia94304-
Stanford University Medical CenterPalo AltoCalifornia94305-
UC San Diego Medical Center - HillcrestSan DiegoCalifornia92103-
Santa Monica UCLA Hematology & Oncology ClinicSanta MonicaCalifornia90404-
Stanford University Medical CenterStanfordCalifornia94305-
Georgetown University Medical Center Department of Pharmacy, ResearchWashington D.C.District of Columbia20007-
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007-
Emory University HospitalAtlantaGeorgia30322-
Emory University Hospital MidtownAtlantaGeorgia30308-
The Emory ClinicAtlantaGeorgia30322-
The Emory Clinic, Building AAtlantaGeorgia30322-
Winship Cancer InstituteAtlantaGeorgia30322-
Brigham and Woman's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
University of Michigan Health SystemAnn ArborMichigan48109-
Siteman Cancer Center - St. PetersCity of Saint PetersMissouri63376-
Siteman Cancer Center-West CountyCreve CoeurMissouri63141-
Barnes-Jewish HospitalSt LouisMissouri63110-1094-
Barnes-Jewish HospitalSt LouisMissouri63110-
Siteman Cancer Center- South CountySt LouisMissouri63129-
Washington University Infusion Center PharmacySt LouisMissouri63110-
Washington University School of MedicineSt LouisMissouri63110-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
The University of Texas - M.D. Anderson Cancer CenterHoustonTexas77030-
South Texas Accelerated Research Therapeutics, LLCSan AntonioTexas78229-
Seattle Cancer Care AllianceSeattleWashington98109-
University of Washington Medical CenterSeattleWashington98195-

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