Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
Verified January 2014 by Pronai Therapeutics, Inc
Information provided by (Responsible Party):
Pronai Therapeutics, Inc
First received: November 20, 2012
Last updated: January 24, 2014
Last verified: January 2014
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||PNT2258-02: A Pilot Phase II Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
Primary Outcome Measures:
Secondary Outcome Measures:
- 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.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Written informed consent must be obtained from the patient.
- Participants must be ≥18 years of age.
- Morphologically confirmed diagnosis of non-Hodgkin's lymphoma (NHL).
- At least a single measureable tumor mass (long axis > 1.5 cm).
An FDG-PET positive baseline scan.
a. A positive scan is defined per revised Cheson criteria as "focal or diffuse FDG uptake above background in a location incompatible with normal anatomy or physiology, without a specific standardized uptake value cutoff".
Disease that has relapsed after administration of primary therapy that included:
- Rituximab and
- CHOP, EPOCH, bendamustine or similar chemotherapy or subsequent salvage regimen.
Note: Relapse is defined as progression after a complete response to therapy or radiographic evidence of active disease after a partial response or stable disease.
- Have received three or fewer complete courses of systemic cytotoxic regimens. Note: Rituximab (alone or in combination with cytotoxic chemotherapy) is not considered a cytotoxic regimen.
- No previous exposure to PNT2258.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Have discontinued all prior anti-cancer therapies for at least 21 days; biologic therapy for at least 4 half-lives of the drug(s); radio-immunotherapy (10 weeks); autologous stem cell transplantation (SCT) (3 months) and must be at a stable baseline regarding any acute toxicity associated with prior therapy.
Adequate organ function including:
- Hematologic Function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L prior to treatment. Platelets ≥ 100 x 109/L.
- Hepatic: Total Bilirubin ≤ 1.5 x ULN and serum transaminase levels ≤ 2.5 x upper limits of normal (ULN).
- Renal: Serum creatinine ≤2 x ULN or creatinine clearance ≥ 60 mL/min/1.73 m2 for subjects with serum creatinine levels above 2x ULN.
- Candidates for HDT and autologous SCT. Note: Patients who progressed > 3 months after high-dose therapy (HDT)/SCT are eligible.
- Concurrent malignancies requiring treatment.
- Symptomatic central nervous system (CNS) or leptomeningeal involvement of lymphoma.
- Concurrent serious medical conditions (as determined by the Principal Investigator) including, but not limited to, HIV-associated lymphoma; active bacterial, fungal or viral infections.
- Signs and symptoms of heart failure characterized as greater than New York Heart Association (NYHA) Class I.
- History of myocardial infarct or prolonged corrected QT (QTc) interval (>450 milliseconds (msecs) for males or >470 msecs for females) or other significant cardiac abnormalities.
- Women who are pregnant or breast-feeding.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733238
|Horizon Oncology Research, Inc.
|Lafayette, Indiana, United States, 47905 |
|Principal Investigator: Wael A. Harb, M.D. |
|Cancer and Hematology Centers of Western Michigan, P.C.
|Grand Rapids, Michigan, United States, 49503 |
|Principal Investigator: Nehal Lakhani, M.D. |
|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. |
Pronai Therapeutics, Inc
||Ayad M. Al-Katib, M.D.
||St. John Hospital and Medical Center
No publications provided
||Pronai Therapeutics, Inc
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 20, 2012
||January 24, 2014
||United States: Food and Drug Administration
Keywords provided by Pronai Therapeutics, Inc:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2014
Neoplasms by Histologic Type
Immune System Diseases