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

First listed
Mar 2, 2011
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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