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Phase I Study of mPEG-R-Crisantaspase Given IV

NCT01551524 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-05-07

No results posted yet for this study

Summary

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.

Conditions

Interventions

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%

Sponsors & Collaborators

  • EUSA SAS

    collaborator UNKNOWN

  • The Lymphoma Academic Research Organisation

    collaborator OTHER

  • Jazz Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Pr Gilles Salles, MD · Centre Hospitalier Lyon Sud -Chemin du Grand Revoyet

  • Xavier Thomas, MD · Centre Hospitalier Lyon Sud - Chemin du Grand Revoyet

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01551524 on ClinicalTrials.gov