Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Primary Completion Date :||August 2016|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|