Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Pronai Therapeutics, Inc
Sponsor:
Information provided by (Responsible Party):
Pronai Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT01733238
First received: November 20, 2012
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Lymphoma, Non-Hodgkin's
Drug: PNT2258
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Pronai Therapeutics, Inc:

Primary Outcome Measures:
  • 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.


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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 15
Study Start Date: November 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PNT2258
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.
Drug: PNT2258

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent must be obtained from the patient.
  2. Participants must be ≥18 years of age.
  3. Morphologically confirmed diagnosis of non-Hodgkin's lymphoma (NHL).
  4. At least a single measureable tumor mass (long axis > 1.5 cm).
  5. 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".

  6. Disease that has relapsed after administration of primary therapy that included:

    1. Rituximab and
    2. 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.

  7. 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.
  8. No previous exposure to PNT2258.
  9. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  10. 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.
  11. Adequate organ function including:

    1. Hematologic Function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L prior to treatment. Platelets ≥ 100 x 109/L.
    2. Hepatic: Total Bilirubin ≤ 1.5 x ULN and serum transaminase levels ≤ 2.5 x upper limits of normal (ULN).
    3. Renal: Serum creatinine ≤2 x ULN or creatinine clearance ≥ 60 mL/min/1.73 m2 for subjects with serum creatinine levels above 2x ULN.

Exclusion Criteria:

  1. Candidates for HDT and autologous SCT. Note: Patients who progressed > 3 months after high-dose therapy (HDT)/SCT are eligible.
  2. Concurrent malignancies requiring treatment.
  3. Symptomatic central nervous system (CNS) or leptomeningeal involvement of lymphoma.
  4. Concurrent serious medical conditions (as determined by the Principal Investigator) including, but not limited to, HIV-associated lymphoma; active bacterial, fungal or viral infections.
  5. Signs and symptoms of heart failure characterized as greater than New York Heart Association (NYHA) Class I.
  6. 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.
  7. Women who are pregnant or breast-feeding.
  Contacts and Locations
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

Contacts
Contact: Shari Gaylor, RN-CCRA/CCRC 269-226-9801 sgaylor@pronai.com

Locations
United States, Indiana
Horizon Oncology Research, Inc. Recruiting
Lafayette, Indiana, United States, 47905
Principal Investigator: Wael A. Harb, M.D.         
United States, Michigan
Cancer and Hematology Centers of Western Michigan, P.C. Recruiting
Grand Rapids, Michigan, United States, 49503
Principal Investigator: Nehal Lakhani, M.D.         
St. John Hospital and Medical Center, Van Elslander Cancer Center Recruiting
Grosse Pointe Woods, Michigan, United States, 48236
Principal Investigator: Ayad M. Al-Katib, M.D.         
Sponsors and Collaborators
Pronai Therapeutics, Inc
Investigators
Principal Investigator: Ayad M. Al-Katib, M.D. St. John Hospital and Medical Center
  More Information

No publications provided

Responsible Party: Pronai Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT01733238     History of Changes
Other Study ID Numbers: PNT2258-02
Study First Received: November 20, 2012
Last Updated: January 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pronai Therapeutics, Inc:
PNT2258
Lymphoma
Non-Hodgkin's Lymphoma
NHL

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2014