A Dose Escalation Phase I Study of Asparec®(mPEG-R-Crisantaspase) Administered as Intravenous (IV) Infusion in Patients With Relapsed or Refractory Hematological Malignancies
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
36
1 country
5
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2015
Actual (reported)Study Completion
February 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
March 8, 2012
Actual (reported)March 12, 2012
Actual (reported)February 2015
Actual (reported)February 2015
Actual (reported)Maximum Tolerated Dose
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.
6 months
Asparaginase Activity in serum
6 months
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%
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Centre Henri Becquerel
Rouen, Cedex, 76038, France
Hôpital Henri Mondor
Créteil, 94010, France
Hôpitaux du CHU de Nantes
Nantes, France
Hospices Civils de Lyon
Pierre-Bénite, 69495, France
Institut Claudius Regaud
Toulouse, 31052, France
Pr Gilles Salles, MD
Centre Hospitalier Lyon Sud -Chemin du Grand Revoyet
Xavier Thomas, MD
Centre Hospitalier Lyon Sud - Chemin du Grand Revoyet
First Submitted
March 8, 2012
First Posted
March 12, 2012
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2015
Actual (reported)Contact the study team to confirm eligibility.
Study Completion
February 2015
Actual (reported)Last Updated
May 7, 2015
Record last verified: 2015-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: