Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT01733238|
Recruitment Status : Completed
First Posted : November 26, 2012
Last Update Posted : January 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Non-Hodgkin's||Drug: PNT2258||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PNT2258-02: A Pilot Phase II Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
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.
- Anti-tumor activity [ Time Frame: 4.5 months ]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 ]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 ]The pharmacokinetic profile will be assessed by blood collection during Cycle 1.
- Pharmacodynamic Effect of PNT2258 [ Time Frame: 4 weeks ]The pharmacodynamic effect of PNT2258 will be assessed by blood collection during Cycles 1 and 2.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Study Chair:||Barbara Klencke, M.D.||Sierra Oncology, Inc.|
|Principal Investigator:||Ayad Al-Katib, MD||St. John Hospital and Medical Center, Van Elslander Cancer Center|