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 — DRUGIntravenous, Dose escalation, once per month
- rituximab — DRUGIntravenous, 375 mg/m2, once per week for 4 weeks
- PF-05082566 — DRUGIV, 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 APF-05082566 single agent in patients with advanced cancer
- Experimental: Portion BPF-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)
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City of Hope· Duarte, CAUC San Diego Medical Center-La Jolla (Jacobs Medical Center/Thornton Hospital)· La Jolla, CAUC San Diego Moores Cancer Center· La Jolla, CAUC San Diego Moores Cancer Center-Investigational Drug Services· La Jolla, CAResearch Administration Office: Clinical Research Unit· Los Angeles, CARonald Reagan UCLA Medical Center, Drug Information Center· Los Angeles, CA
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