Back to resultsSafety and Tolerability of I-040302 in Children and Young Adults With Solitary Bone Cysts
Primary Purpose
Bone Cysts
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
I-040302
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Bone Cysts focused on measuring Osteogenic Gel, Solitary Bone Cysts
Eligibility Criteria
Inclusion Criteria:
- 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:
- 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.
Exclusion Criteria:
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
I-040302 doses of up to 1 mg, 2 mg or 4 mg of TGplPTH1-34
Standard of care (bone marrow aspirate or steroids)
Outcomes
Primary Outcome Measures
Radiographic images
Secondary Outcome Measures
Blood parameters
Vital signs
Questionnaires of life questionnaire
Pharmacoeconomic evaluation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00459641
Brief Title
Safety and Tolerability of I-040302 in Children and Young Adults With Solitary Bone Cysts
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Stopped before any site initiation or any recruitment due to change in overall product development plan
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
July 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuros Biosurgery AG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Cysts
Keywords
Osteogenic Gel, Solitary Bone Cysts
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
I-040302 doses of up to 1 mg, 2 mg or 4 mg of TGplPTH1-34
Arm Title
2
Arm Type
Active Comparator
Arm Description
Standard of care (bone marrow aspirate or steroids)
Intervention Type
Drug
Intervention Name(s)
I-040302
Intervention Description
doses of up to 1 mg, 2 mg or 4 mg of TGplPTH1-34
Intervention Type
Other
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
Bone marrow aspirate or steroids
Intervention Description
Bone marrow aspirate or steroids
Primary Outcome Measure Information:
Title
Radiographic images
Time Frame
At 6 months and throughout the study
Secondary Outcome Measure Information:
Title
Blood parameters
Time Frame
At 6 months and throughout the study
Title
Vital signs
Time Frame
At 6 months and throughout the study
Title
Questionnaires of life questionnaire
Time Frame
At 6 months and throughout the study
Title
Pharmacoeconomic evaluation
Time Frame
At 6 months and throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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:
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.
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia Jamieson, MD
Organizational Affiliation
Kuros Biosurgery AG, Technoparkstrasse 1, CH-8005 Zurich
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Safety and Tolerability of I-040302 in Children and Young Adults With Solitary Bone Cysts
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