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

November 20, 2012
January 24, 2014
November 2012
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01733238 on ClinicalTrials.gov Archive Site
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.
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 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.
Same as current
 
Study of PNT2258 for Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
PNT2258-02: A Pilot Phase II 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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma, Non-Hodgkin's
Drug: PNT2258
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.
Intervention: Drug: PNT2258
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
December 2015
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Shari Gaylor, RN-CCRA/CCRC 269-226-9801 sgaylor@pronai.com
United States
 
NCT01733238
PNT2258-02
Yes
Pronai Therapeutics, Inc
Pronai Therapeutics, Inc
Not Provided
Principal Investigator: Ayad M. Al-Katib, M.D. St. John Hospital and Medical Center
Pronai Therapeutics, Inc
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP