A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab
Conditions
Lymphoma, Non-Hodgkin
Conditions: official terms
Lymphoma, Non-Hodgkin
Conditions: Keywords
Phase 1, Non-Hodgkin's Lymphoma, Advanced malignancies
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: PF-05082566 Type: Drug
Name: rituximab Type: Drug
Name: PF-05082566 Type: Drug
Overall Status
Recruiting
Summary
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Portion A: Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy or B cell lymphoma, for which no curative therapy is available.

- Portion B: Histological confirmed relapsed or refractory CD20 positive NHL for which no curative therapy is available, including SLL/CLL with nodal disease (not including SLL/CLL with >10,000 lymphocytes/μL, prolymphocytic leukemia, hairy cell leukemia, heavy chain disease, plasma cell myeloma, solitary plasmacytoma of bone, extraosseous plasmacytoma, lymphomatoid granulomatosis, and large B cell lymphoma arising in Castleman disease). Additionally, patients enrolled in the MTD expansion cohort must have tumor accessible for repeat biopsy (core needle biopsy preferred).

- Age 18 years or older. Eastern Cooperative Oncology Group (ECOG) performance status of greater than or equal to 1.

- Adequate bone marrow function, for Portion A defined as absolute neutrophil count (ANC) ≥1.5 x 109/L (≥1,500/μL), platelet count ≥100 x 109/L (≥100,000/μL), and hemoglobin >9.0 g/dL (>5.6 mmol/L), and for Portion B as ANC ≥1.0 x 109/L (≥1,000/uL), platelet count ≥75 x 109/L (≥75000/μL), and hemoglobin >9.0 g/dL (>5.6 mmol/L). (For patients enrolled in Japan, hemoglobin >8.5 g/dL (>5.3 mmol/L). In both cases, patients must be transfusion independent (ie, no blood product transfusions for a period of at least 14 days prior to screening).

- Adequate Renal Function, including serum creatinine ≤1.5 x upper limit of normal (ULN) or estimated creatinine clearance ≥60 ml/min as calculated using the method standard for the institution.

- Adequate Liver Function, including: a) Total serum bilirubin ≤1.5 x ULN unless the patient has documented Gilbert syndrome; b) Aspartate and Alanine Aminotransferase (AST and ALT) ≤2.0 x ULN; c) Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN in case of bone metastasis).

- Adequate Cardiac Function, as measured by left ventricular ejection fraction (LVEF) that is greater than 40%, or the presence of New York Heart Association (NYHA) classification of no greater than stage II congestive heart failure.

Exclusion Criteria:

- Therapeutic or experimental monoclonal antibodies in last 60 days prior to first dose of study drug.

- Prior therapy with a compound of the same mechanism (interacting with 4-1BB)

- Chemotherapy, cancer immunosuppressive therapy, growth factors, systemic steroids, or investigational agents within 28 days before the first dose of study treatment (for the purposes of this protocol, study treatment includes rituximab in Portion B).

- Prior allogeneic hematopoietic stem cell transplant.

- Central nervous system (CNS) primary or CNS metastatic malignancies.
Locations
Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles, California, United States
Status: Recruiting
UCLA Bowyer Clinic
Los Angeles, California, United States
Status: Recruiting
UCLA Department of Medicine
Los Angeles, California, United States
Status: Recruiting
UCLA Hematology-Oncology Clinic
Los Angeles, California, United States
Status: Recruiting
Stanford University Medical Center
Palo Alto, California, United States
Status: Active, not recruiting
Stanford University Medical Center
Stanford, California, United States
Status: Active, not recruiting
Stanford University Medical Center
Stanford, California, United States
Status: Active, not recruiting
Drug Shipment Address and Pharmacist Designees
Washington, District of Columbia, United States
Status: Recruiting
Georgetown University Hospital
Washington, District of Columbia, United States
Status: Recruiting
Barnes-Jewish Hospital
St. Louis, Missouri, United States
Status: Recruiting
Barnes-Jewish Hospital
St. Louis, Missouri, United States
Status: Recruiting
Washington University Infusion Center Pharmacy
St. Louis, Missouri, United States
Status: Recruiting
Washington University School of Medicine
St. Louis, Missouri, United States
Status: Recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Status: Recruiting
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, United States
Status: Recruiting
Centre d'investigation clinique
RENNES cedex 9, France
Status: Terminated
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Status: Recruiting
Start Date
June 2011
Completion Date
December 2017
Sponsors
Pfizer
Source
Pfizer
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page