Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
This study is a multi-center, nonrandomized, open-label, pilot Phase II investigation of PNT2258 to characterize anti-tumor activity and collect safety data on patients with relapsed or refractory lymphoma.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||PNT2258-02: A Pilot Phase II Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma|
- Anti-tumor activity [ Time Frame: 4.5 months ] [ Designated as safety issue: No ]Anti-tumor activity will be assessed by Computerized Tomography (CT) scan, FDG-Positron Emission Tomography (PET) scan and biomarker analysis.
- Safety [ Time Frame: 4.5 months ] [ Designated as safety issue: No ]Safety will be assessed by physical examination, clinical laboratory tests (i.e., hematology, chemistry, urinalysis) and electrocardiogram.
- Pharmacokinetic Profile of PNT2258 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]The pharmacokinetic profile will be assessed by blood collection during Cycle 1.
- Pharmacodynamic Effect of PNT2258 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]The pharmacodynamic effect of PNT2258 will be assessed by blood collection during Cycles 1 and 2.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
PNT2258 120 mg/m2 will be administered as a 2-hour intravenous infusion 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 6 cycles of therapy.
PNT2258 will be administered at a dose of 120 mg/m2, as a 3-hour intravenous (IV) infusion 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 6 cycles of therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733238
|United States, Indiana|
|Horizon Oncology Research, Inc.|
|Lafayette, Indiana, United States, 47905|
|United States, Michigan|
|Cancer and Hematology Centers of Western Michigan, P.C.|
|Grand Rapids, Michigan, United States, 49503|
|St. John Hospital and Medical Center, Van Elslander Cancer Center|
|Grosse Pointe Woods, Michigan, United States, 48236|
|Principal Investigator:||Ayad M. Al-Katib, M.D.||St. John Hospital and Medical Center|