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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01307267
First received: February 28, 2011
Last updated: August 5, 2014
Last verified: August 2014

February 28, 2011
August 5, 2014
June 2011
December 2015   (final data collection date for primary outcome measure)
  • Number of participants with Dose-limiting toxicities (DLT) [ Time Frame: First 2 cycles of treatment ] [ Designated as safety issue: Yes ]
    Dose Limiting Toxicities (DLTs) of PF-05082566 as single agent
  • Number of participants with Dose-limiting toxicities (DLT) [ Time Frame: First 2 cycles of treatment ] [ Designated as safety issue: Yes ]
    Dose Limiting Toxicities (DLTs) of PF-05082566 in combination with rituximab
Dose Limiting Toxicities (DLTs) of PF-05082566 as single agent and in combination with rituximab [ Time Frame: First 2 cycles of treatment ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01307267 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics of PF-05082566 and rituximab when given in combination [ Time Frame: Cycles 1 through 4 and end of treatment ] [ Designated as safety issue: Yes ]
    Pharmacokinetics of PF-05082566 and rituximab when given in combination
  • Pharmacokinetics of PF-05082566 as a single agent [ Time Frame: Cycles 1 through 4 and end of treatment ] [ Designated as safety issue: Yes ]
    Pharmacokinetics of PF-05082566 and rituximab when given in combination
  • Presence of Anti-Drug Antibodies against PF-05082566 (Portion A) [ Time Frame: Cycles 1 through 4 and end of treatment ] [ Designated as safety issue: Yes ]
  • Presence of Anti-Drug Antibodies against PF-05082566 and rituximab (Portion B) [ Time Frame: Cycles 1 through 4 and end of treatment ] [ Designated as safety issue: Yes ]
  • Analysis of biomarkers linked with immunomodulation/cytokine release [ Time Frame: Cycles 1 through 4 and end of treatment ] [ Designated as safety issue: Yes ]
  • Analysis of exploratory pharmacodynamic biomarkers [ Time Frame: Cycles 1 through 4 and end of treatment ] [ Designated as safety issue: Yes ]
  • Efficacy as measured by: Objective Response Rate, Duration of Response, Progression Free Survival and Overall Survival of PF-05082566 as a single agent [ Time Frame: Assessed once every 8 weeks ] [ Designated as safety issue: Yes ]
  • Efficacy as measured by: Objective Response Rate, Duration of Response, Progression Free Survival and Overall Survival of PF-05082566 and rituximab when given in combination [ Time Frame: Assessed once every 8 weeks ] [ Designated as safety issue: Yes ]
  • Adverse events, laboratory abnormalities [ Time Frame: Throughout Study ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics, Pharmacodynamics, Biomarkers [ Time Frame: Throughout Study ] [ Designated as safety issue: Yes ]
  • Anti-Drug Antibody levels [ Time Frame: Throughout Study ] [ Designated as safety issue: Yes ]
  • QTc interval [ Time Frame: Throughout Study ] [ Designated as safety issue: Yes ]
  • Efficacy [ Time Frame: Throughout Study ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab
A Phase 1 Study Of PF-05082566 As A Single Agent In Patients With Advanced Cancer, And In Combination With Rituximab In Patients With Non-Hodgkin's Lymphoma (NHL)

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).

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma, Non-Hodgkin
  • Drug: PF-05082566
    Intravenous, Dose escalation, once per month
  • Drug: rituximab
    Intravenous, 375 mg/m2, once per week for 4 weeks
    Other Name: Rituxan, MabThera
  • Drug: PF-05082566
    IV, Dose escalation, once per month
  • Experimental: A
    PF-05082566 single agent in patients with advanced cancer
    Intervention: Drug: PF-05082566
  • Experimental: B
    PF-05082566 in combination with rituximab in patients with Non-Hodgkin's Lymphoma
    Interventions:
    • Drug: rituximab
    • Drug: PF-05082566
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
78
December 2016
December 2015   (final data collection date for primary outcome measure)

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). 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.
Both
18 Years and older
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States,   France
 
NCT01307267
B1641001
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP