NeoplasmsPhase 2NCT00219791
Study of Glucarpidase (CPG2) for the Management of Patients With Delayed Methotrexate Clearance
A Phase 2 study testing glucarpidase (50 Units/kg) in people with Neoplasms, run by BTG International Inc. at 1 site in Germany.
Trial summary
To evaluate the safety and efficacy of glucarpidase in patients with impaired methotrexate (MTX) clearance owing to MTX-induced renal failure following high-dose MTX therapy, or with intrathecal MTX overdose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- glucarpidase (50 Units/kg)
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Jan 2000to Jun 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent by patient or legally valid representative
- Patients receiving high-dose MTX (>1 g/m2 body surface area (BSA) given as an infusion over 24 hours) for the treatment of ALL, NHL or a solid tumour (e.g. osteosarcoma)
- Age ≥ 18 years
- Serum MTX >5 µmol/L 42 hours or later after the start of MTX infusion, or serum MTX >1 μmol/L 42 hours or later after the start of MTX infusion together with renal insufficiency, or serum MTX >0.4 µmol/L 48 hours or later after the start of MTX infusion together with renal insufficiency. Renal insufficiency was defined as serum creatinine >1.5 × the upper limit of normal (ULN) and/or oliguria (urine output < 500 mL/24 hours despite adequate hydration, diuretics and alkalinisation).
Who cannot join
- Pregnant or lactating females
- Unwillingness of patient or relative/legal representative to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Recombinant Carboxypeptidase G2 (CPG2) for the Management of Patients With Delayed Methotrexate (MTX) Clearance or Intrathecal MTX Overdosage
To evaluate the safety and efficacy of glucarpidase in patients with impaired methotrexate (MTX) clearance owing to MTX-induced renal failure following high-dose MTX therapy, or with intrathecal MTX overdose.
- Conditions
- Neoplasms
- Being tested
- glucarpidase (50 Units/kg)
- Keywords
- methotrexate, delayed elimination, renal insufficiency, CPG2, Voraxaze
- Medical subject headings
- Neoplasms, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucarpidase (50 Units/kg)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in serum MTX concentration
Secondary outcomes (9)
serum blood-urea-nitrogen
serum creatinine
creatinine clearance
haematology (complete blood count and differential)
biochemistry (electrolytes, SGOT, SGPT, alkaline phosphatase, bilirubin, total protein)
urinalysis (dip-stick)
MTX-related toxicity
Adverse events
Mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2000
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- BTG International Inc.
- Sponsor type
- University, hospital or other
- Investigators
- Thiel Eckhard, Prof. Dr.med., Principal investigator, Charite - Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219791
- Sponsor's protocol ID
- PR001-CLN-rpt002
- Other IDs
- ek.179-6
- Status last verified
- Sep 2014
- First submitted
- 15 Sep 2005
- Last updated
- 11 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Recombinant Carboxypeptidase G2 (CPG2) for the Management of Patients With Delayed Methotrexate (MTX) Clearance or Intrathecal MTX Overdosage
- ClinicalTrials.gov ID
- NCT00219791
- Acronym / sponsor ID
- PR001-CLN-rpt002
- Conditions
- Neoplasms
- Keywords
- methotrexate, delayed elimination, renal insufficiency, CPG2, Voraxaze
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- BTG International Inc.University, hospital or other
- Study start
- Jan 2000
- Study completion
- Jun 2003
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of glucarpidase in patients with impaired methotrexate (MTX) clearance owing to MTX-induced renal failure following high-dose MTX therapy, or with intrathecal MTX overdose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent by patient or legally valid representative
- Patients receiving high-dose MTX (>1 g/m2 body surface area (BSA) given as an infusion over 24 hours) for the treatment of ALL, NHL or a solid tumour (e.g. osteosarcoma)
- Age ≥ 18 years
- Serum MTX >5 µmol/L 42 hours or later after the start of MTX infusion, or serum MTX >1 μmol/L 42 hours or later after the start of MTX infusion together with renal insufficiency, or serum MTX >0.4 µmol/L 48 hours or later after the start of MTX infusion together with renal insufficiency. Renal insufficiency was defined as serum creatinine >1.5 × the upper limit of normal (ULN) and/or oliguria (urine output < 500 mL/24 hours despite adequate hydration, diuretics and alkalinisation).
Key exclusion criteria (2 listed)
- Pregnant or lactating females
- Unwillingness of patient or relative/legal representative to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glucarpidase (50 Units/kg) | Drug | – |
Primary outcome
Reduction in serum MTX concentration
9 secondary outcomes
serum blood-urea-nitrogen
serum creatinine
creatinine clearance
haematology (complete blood count and differential)
biochemistry (electrolytes, SGOT, SGPT, alkaline phosphatase, bilirubin, total protein)
urinalysis (dip-stick)
MTX-related toxicity
Adverse events
Mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thiel Eckhard, Prof. Dr.med. principal investigator
Charite - Universitätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing glucarpidase (50 Units/kg) in people with Neoplasms, run by BTG International Inc. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in serum MTX concentration. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2014.