Ph 1 Study of ADI PEG 20 in Pediatric Subjects Who Are Argininosuccinate Synthetase (ASS) Deficient
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ClinicalTrials.gov Identifier: NCT01528384 |
Recruitment Status
:
Completed
First Posted
: February 8, 2012
Last Update Posted
: April 9, 2014
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Sponsor:
Polaris Group
Information provided by (Responsible Party):
Polaris Group
Tracking Information | ||||
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First Submitted Date ICMJE | January 14, 2012 | |||
First Posted Date ICMJE | February 8, 2012 | |||
Last Update Posted Date | April 9, 2014 | |||
Study Start Date ICMJE | December 2011 | |||
Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change in laboratory values. [ Time Frame: 2 years ] Change from baseline in laboratory values, as a measure of safety.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01528384 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Results of diagnostic imaging using RECIST criteria. [ Time Frame: 2 years ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Ph 1 Study of ADI PEG 20 in Pediatric Subjects Who Are Argininosuccinate Synthetase (ASS) Deficient | |||
Official Title ICMJE | A Phase 1 Study of ADI PEG 20 in Pediatric Subjects Who Are Argininosuccinate Synthetase (ASS) Deficient and Have Failed Prior Systemic Therapy | |||
Brief Summary | This is a phase 1 study of pegylated arginine deiminase (ADI-PEG 20) in pediatric patients who deficient in the expression of tumor argininosuccinate synthetase, and have failed prior treatments. The study hypothesis is that this drug will be safe in pediatric patients. | |||
Detailed Description | This phase 1 study will use a classic 3 dose levels by 3 patients per dose level design. Once the maximum tolerated dose is reached, additional patients may be enrolled at that dose level. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Argininosuccinate Synthetase Deficient | |||
Intervention ICMJE | Drug: ADI-PEG 20
4.5, 9 and 18 mg/m2 dosage weekly dosing intramuscular until progressive disease
Other Name: pegylated arginine deiminase |
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Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
8 | |||
Original Estimated Enrollment ICMJE |
30 | |||
Actual Study Completion Date | March 2014 | |||
Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 4 Years to 18 Years (Child, Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01528384 | |||
Other Study ID Numbers ICMJE | POLARIS2009-002 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Polaris Group | |||
Study Sponsor ICMJE | Polaris Group | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Polaris Group | |||
Verification Date | April 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |