Phase I Study of mPEG-R-Crisantaspase Given IV

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Jazz Pharmaceuticals
Sponsor:
Collaborator:
EUSA Pharma USA
Information provided by (Responsible Party):
Jazz Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01551524
First received: March 8, 2012
Last updated: May 16, 2013
Last verified: February 2013
  Purpose

This study is an open label, multicenter study with a dose escalation of Asparec® administered once every two to four weeks for two administrations. The primary objective of this study is to determine the Maximum Tolerated Dose following one single dose of Asparec when administered in a population of patients with relapsed or refractory hematological malignancies, as measured by Dose Limiting toxicities. There are secondary objectives which are to evaluate the safety of Asparec and to determine the PK profile as assessed by measurement of plasma L-asparaginase enzymatic activity following single and repeated doses of Asparec. Patients response rate will be evaluated and Anti-Asparec antibodies will be measured.


Condition Intervention Phase
Hematologic Malignancies
Biological: mPEG-r-crisantaspase
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Dose Escalation Phase I Study of Asparec®(mPEG-R-Crisantaspase) Administered as Intravenous (IV) Infusion in Patients With Relapsed or Refractory Hematological Malignancies

Resource links provided by NLM:


Further study details as provided by Jazz Pharmaceuticals:

Primary Outcome Measures:
  • Maximum Tolerated Dose [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    To determine the Maximum Tolerated Dose following one single dose of mPEG-r-Crisantaspase when administered in a population of patients with relapsed or refractory hematological malignancies, as measured by Dose Limiting Toxicities.


Secondary Outcome Measures:
  • Asparaginase Activity in serum [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    To determine the pharmacokinetic profile as assessed by measurement of serum L-asparaginase enzymatic activity following single and double mPEG-r-chrisantaspace doses.


Estimated Enrollment: 36
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intravenous Erwinia Biological: mPEG-r-crisantaspase
IV infusion over 60 minutes of mPEG-r-crisantaspase given once every two or four weeks for two administrations. Based on non-clinical data, 500IU/m2 has been selected as the starting dose. Dose selection will proceed based upon safety and pharmacokinetic data but escalation will not exceed 100%
Other Name: Asparec

Detailed Description:

Planned sample size: Up to 36 evaluable subjects will be enrolled in the study: a maximum of 30 subjects for the dose escalation phase and up to a maximum of 12 patients in the expansion phase.

Inclusion criteria consists of:

Patients with any relapsed or refractory hematological malignancy, for which standard curative or life prolonging treatment does not exist, or is no longer effective or tolerable.

For the following hematological malignancies, patients must have received at least: Low rade NHL: 3 prior lines of therapy, ALL, aggressive NHL and other hematological malignancies: 2 prior lines of therapy, Aged 18 to 50 years and ECOG performance status of 1, 1 or 2.

All patients will be treated with Asparec once every two to four weeks for two IV administrations infused in 60 minutes. Patients without Disease Progression may receive additional administrations, each administration starting at least 14 days but no later than 28 days after the previous Asparec administration.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with any relapsed or refractory hematological malignancy, for which standard curative or life prolonging treatment does not exist, or is no longer effective or tolerable.
  • For the following hematological malignancies, patients must have received at least:

    • Low grade NHL:

      • 3 prior lines of therapy and ALL,
    • aggressive NHL and other hematological malignancies:

      • 2 prior lines of therapy.
  • Ages 18 to 50 years and
  • ECOG performance status of 0, 1 or 2,
  • ability to understand and to sign a written informed consent and
  • have a life expectancy of greater than or equal to 90 days

Exclusion Criteria:

  • Any active CNS disease,
  • previous greater than or equal to grade 3 allergic reaction to Erwinase,
  • patients who have experienced a greater than or equal to grade 3 allergic reaction to E. coli L-asparaginase and who have never received E. chrysanthemi L-asparaginase after the occurrence of this reaction,
  • WBC count greater than 20 Gica/L, any of the following laboratory abnormalities if not due to hematologic malignancy (calculated creatinine clearance less than 50 mL/min,
  • serum SGOT/AST or SGPT?ALT greater than 2.5 x upper limit of normal,
  • serum total bilirubin greater than 2.0 mg/dL, except in the case of hemolytic anemia.
  • Patients cannot have a history of greater than or equal to grade 2 pancreatitis,
  • any history of allogeneic transplant,
  • receiving steroid therapy with a dose greater than 20 mg/day,
  • known HIV positive serology,
  • active hepatitis B or C,
  • any serious active disease or comorbid medical condition or psychiatric illness that would prevent the subject from signing the informed consent.
  • Pregnant or lactating females or women of child bearing potential not willing to use an adequate method of birth control for the duration of the study are not eligible.
  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: NCT01551524

Contacts
Contact: Sabine Balouet +33(0) 4 72 66 93 33 sabine.balouet@lysarc.org
Contact: Jardin d'Eole +33(0) 4 37 49 85 85

Locations
France
Centre Hospitalier Lyon Sud Recruiting
Lyon, France
Principal Investigator: Pr Gilles Salles, MD         
Sponsors and Collaborators
Jazz Pharmaceuticals
EUSA Pharma USA
Investigators
Principal Investigator: Pr Gilles Salles, MD Centre Hospitalier Lyon Sud -Chemin du Grand Revoyet
Study Director: Xavier Thomas, MD Centre Hospitalier Lyon Sud - Chemin du Grand Revoyet
  More Information

No publications provided

Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01551524     History of Changes
Other Study ID Numbers: AZPO2-CLT-001, 2011-000295-34
Study First Received: March 8, 2012
Last Updated: May 16, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Jazz Pharmaceuticals:
Leukemia
Lymphoma
C240588.448
C115.378.400

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Asparaginase
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014