PNT2258 for Treatment of Patients With r/r DLBCL (Wolverine)
NCT ID: NCT02226965
Last Updated: 2023-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
45 participants
INTERVENTIONAL
2014-12-31
2018-08-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PNT2258
PNT2258 will be administered at 120 mg/m2 on days 1-5 of a 21-day cycle. Treatment may continue unless there is disease progression or the occurrence of unacceptable toxicity for a total of 8 "induction" cycles of therapy. Subjects with CR/CMR, PR/PMR or SD/NMR at the end-of-cycle 8 scan then receive ongoing PNT2258 therapy at a dose of 100 mg/m2 on days 1-4 of a 28 day cycle until progressive disease, the occurrence of unacceptable toxicity, non-compliance, voluntary withdrawal or if in the opinion of the investigator the subject is no longer benefiting from exposure to PNT2258.
PNT2258
Interventions
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PNT2258
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
FDG PET-CT (disease) positive baseline scan with measurable disease.
The patient must have received prior therapy that included:
* CD20-targeted therapy (for example, rituximab),
* Alkylating agent (for example, cyclophosphomide), and
* Steroid, unless the patient is steroid intolerant
Exposure to at least 1 or 2 (but no more than 3) prior systemic cytotoxic chemotherapeutic regimens.
Note: Only those subjects who are not eligible for high-dose chemotherapy and autologous stem cell transplant (HD-ASCT), or who refuse HD-ASCT, are eligible with exposure to only 1 prior cytotoxic chemotherapeutic regimen.
ECOG performance status of 0-1.
The patient must be a stable baseline with CTCAE grade ≤ 2 regarding any acute or chronic toxicity associated with prior therapy, and have discontinued prior anti-cancer therapy for ≥ 14 days prior to C1D1; mitomycin-C for at least 6 weeks prior to C1D1; SCT ≥ 2 months prior to C1D1.
Note: Palliative steroids for control of disease-related symptoms are allowed and maintenance hormone therapy is allowed.
Adequate organ function including:
* Hematologic: ANC ≥ 0.5 x 10\^9/L. and platelets ≥ 50 x 10\^9/L.
* Hepatic: Total Bilirubin ≤ 2 x ULN (patients with Gilbert's syndrome must have total bilirubin ≤ 3 x ULN) and serum transaminase levels ≤ 2.5 x ULN. In the case of known liver metastasis (i.e., radiological or biopsy documented), serum transaminase levels must be ≤ 5 x ULN.
* Renal: Serum creatinine ≤ 2 x ULN, or creatinine clearance ≥ 60 mL/min/1.73 m2 for subjects with serum creatinine levels above 2 x ULN.
Willingness to: 1.) undergo pre-treatment biopsy to obtain adequate tissue for analysis (e.g., core needle, excisional or incisional tumor biopsy) or 2.) provide archived tumor (e.g., FFPE block) for analysis.
Exclusion Criteria
Concurrent malignancies requiring treatment.
Primary mediastinal (thymic) large B-cell lymphoma
Symptomatic CNS or leptomeningeal involvement of lymphoma.
Concurrent clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram or laboratory finding that, in the opinion of the investigator, could adversely affect the safety of the patient or impair the assessment of the study results.
Signs or symptoms of heart failure characterized as greater than NYHA Class II or other significant cardiac abnormalities.
Pregnant or breast-feeding.
Prior exposure to PNT2258.
Life expectancy less than 3 months.
18 Years
ALL
No
Sponsors
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Sierra Oncology LLC - a GSK company
INDUSTRY
Responsible Party
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Principal Investigators
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Barbara Klencke, MD
Role: STUDY_CHAIR
Sierra Oncology LLC - a GSK company
Locations
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Long Beach Memorial Medical Center
Long Beach, California, United States
University of Southern California
Los Angeles, California, United States
Colorado Blood and Cancer Institute
Denver, Colorado, United States
Lynn Cancer Institute
Boca Raton, Florida, United States
Bond Clinic, P.A.
Winter Haven, Florida, United States
Georgia Regents University
Augusta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Horizon Oncology Research, Inc.
Lafayette, Indiana, United States
UHC Oncology
Lafayette, Louisiana, United States
Western Maryland Health System
Cumberland, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States
St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
Michigan State University
Lansing, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Duke University
Durham, North Carolina, United States
Bon Secours Saint Francis Cancer Center
Greenville, South Carolina, United States
Avera Research Institute
Sioux Falls, South Dakota, United States
Baylor Research Institute
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
M.D. Anderson Cancer Center
Houston, Texas, United States
Tyler Hematology Oncology
Tyler, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Peninsula Cancer Institute
Newport News, Virginia, United States
Medical Oncology Associates, PS
Spokane, Washington, United States
Fundacion de Investigacion
San Juan, , Puerto Rico
Countries
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Other Identifiers
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PNT2258-03-DLBCL
Identifier Type: -
Identifier Source: org_study_id
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