Bone CystsPhase 2NCT00459641
Safety and Tolerability of I-040302 in Children and Young Adults With Solitary Bone Cysts
A Phase 2 study testing I-040302 in people with Bone Cysts, run by Kuros Biosurgery AG.
Trial summary
This is a randomised, controlled, open-label study of a single intralesional administration of I-040302 or a single bone marrow aspirate or a single steroid injection (methylprednisolone). Subjects will undergo screening with X-ray and magnetic resonance imaging (MRI) in the diagnosis of a solitary bone cyst. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Bone Cysts
- What is being tested?
- I-040302
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Jul 2019
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects 6 - 16 years of age
- Diagnostic evidence of unicameral bone cysts based on one or more of a combination of any of the following methods:
- Cyst fluid examination
- Plain radiographs
- MRI
- Subjects with the following types of cysts:
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- Intact cysts that are either growing or at risk of fracture, requiring surgical intervention
- Persistence of a cyst cavity following cyst fracture that has received conservative treatment/s to repair the fracture
- Persistence of a cyst cavity despite repeated interventions
- Subjects with bone cyst volumes < 30 mL
- Subjects must be appropriately communicative to verbalise pain.
- Subjects must be able to understand and be willing to comply with the protocol procedures.
- Subjects who have provided written informed consent to participate in the study
- The legally authorised representative of the child must give written informed consent after the child has agreed to participate in the study.
Who cannot join
- A history of/or presence of active cancer
- Family history of retinoblastoma
- Indication of aneurysmal bone cyst on MRI, cyst aspiration or histology
- Possible presence of osteosarcoma or uncertain histology
- Systemic or localised infection at time of surgery
- Evidence of immune-suppression
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- Evidence of hypercalcemia
- Cyst volume > 30 mL
- Fracture present in the cortical bone surrounding the cyst
- Evidence of rapid venous drainage from the cyst determined by rapid disappearance of X-ray contrast medium during the surgical process.
- Suspected or known evidence of allergic reactions towards any of the components of I-040302
- Known clinically significant organ or systemic diseases such that, in the opinion of the investigator, the significance of the disease will compromise the subject's participation in the study
- Pregnant or lactating females
- Participation in another clinical trial within 3 months prior to trial start
About this study
Official title: A Phase 2 Randomised, Open-label, Multi-centre Ascending Dose Study of the Efficacy, Safety and Tolerability of I-040302 Versus Control Injection (Bone Marrow Aspirate or Steroids) in Children and Young Adults With Solitary Bone Cysts
This is a randomised, controlled, open-label study of a single intralesional administration of I-040302 or a single bone marrow aspirate or a single steroid injection (methylprednisolone). Subjects will undergo screening with X-ray and magnetic resonance imaging (MRI) in the diagnosis of a solitary bone cyst.
- Conditions
- Bone Cysts
- Being tested
- I-040302, Standard of Care
- Keywords
- Osteogenic Gel, Solitary Bone Cysts
- Medical subject headings
- Bone Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-040302Drug
doses of up to 1 mg, 2 mg or 4 mg of TGplPTH1-34
Standard of CareOther
Also called Bone marrow aspirate or steroids
Bone marrow aspirate or steroids
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | I-040302 doses of up to 1 mg, 2 mg or 4 mg of TGplPTH1-34 Receives: Drug: I-040302 |
| 2 | Active comparator | Standard of care (bone marrow aspirate or steroids) Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic images
Measured: At 6 months and throughout the study
Secondary outcomes (4)
Blood parameters
Measured: At 6 months and throughout the study
Vital signs
Measured: At 6 months and throughout the study
Questionnaires of life questionnaire
Measured: At 6 months and throughout the study
Pharmacoeconomic evaluation
Measured: At 6 months and throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2007 (estimated)
- Study startDec 2012
- Primary completionJun 2014 (estimated)
- Study completionJul 2019 (estimated)
Why it stopped: Stopped before any site initiation or any recruitment due to change in overall product development plan
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone CystsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuros Biosurgery AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Virginia Jamieson, MD, Study director, Kuros Biosurgery AG, Technoparkstrasse 1, CH-8005 Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459641
- Sponsor's protocol ID
- CS I-040302/01
- Status last verified
- Jul 2012
- First submitted
- 11 Apr 2007
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomised, Open-label, Multi-centre Ascending Dose Study of the Efficacy, Safety and Tolerability of I-040302 Versus Control Injection (Bone Marrow Aspirate or Steroids) in Children and Young Adults With Solitary Bone Cysts
- ClinicalTrials.gov ID
- NCT00459641
- Acronym / sponsor ID
- CS I-040302/01
- Conditions
- Bone Cysts
- Keywords
- Osteogenic Gel, Solitary Bone Cysts
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Stopped before any site initiation or any recruitment due to change in overall product development plan
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kuros Biosurgery AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 12 Apr 2007 (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.
This is a randomised, controlled, open-label study of a single intralesional administration of I-040302 or a single bone marrow aspirate or a single steroid injection (methylprednisolone). Subjects will undergo screening with X-ray and magnetic resonance imaging (MRI) in the diagnosis of a solitary bone cyst.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: I-040302I-040302 doses of up to 1 mg, 2 mg or 4 mg of TGplPTH1-34 |
| 2 | Active comparator | Other: Standard of CareStandard of care (bone marrow aspirate or steroids) |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Subjects 6 - 16 years of age
- Diagnostic evidence of unicameral bone cysts based on one or more of a combination of any of the following methods:
- Subjects with the following types of cysts:
- Subjects with bone cyst volumes < 30 mL
- Subjects must be appropriately communicative to verbalise pain.
Key exclusion criteria (14 listed)
- A history of/or presence of active cancer
- Family history of retinoblastoma
- Indication of aneurysmal bone cyst on MRI, cyst aspiration or histology
- Possible presence of osteosarcoma or uncertain histology
- Systemic or localised infection at time of surgery
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 |
|---|---|---|
| I-040302doses of up to 1 mg, 2 mg or 4 mg of TGplPTH1-34 | Drug | 1 |
| Standard of CareAlso: Bone marrow aspirate or steroidsBone marrow aspirate or steroids | Other | 2 |
Primary outcome
Radiographic images
Time frame: At 6 months and throughout the study
4 secondary outcomes
Blood parameters
Time frame: At 6 months and throughout the study
Vital signs
Time frame: At 6 months and throughout the study
Questionnaires of life questionnaire
Time frame: At 6 months and throughout the study
Pharmacoeconomic evaluation
Time frame: At 6 months and throughout the study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
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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.
Virginia Jamieson, MD study director
Kuros Biosurgery AG, Technoparkstrasse 1, CH-8005 Zurich
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing I-040302 in people with Bone Cysts, run by Kuros Biosurgery AG.
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 14 inclusion and 14 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: withdrawn, as of the sponsor's last update on 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Radiographic images (time frame: At 6 months and throughout the study). 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 17 Jul 2012.