Safety and Tolerability of I-040302 in Children and Young... | NCT00459641

Studies
Safety and Tolerability of I-040302 in Children and Young Adults With Solitary Bone Cysts

NCT00459641

Sponsor

Kuros Biosurgery AG

Status

Withdrawn

Last Update Posted

Jul 17, 2012Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Bone Cysts

Interventions

I-040302
Standard of Care

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Stopped before any site initiation or any recruitment due to change in overall product development plan

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Jun 2014Estimated

Completion Date

Jul 2019Estimated

First Submitted Date

Apr 11, 2007

First Submission Date that Met QC Criteria

Apr 11, 2007

First Posted Date

Apr 12, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2012

Last Update Posted Date

Jul 17, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Label	Type	Description	Intervention Names
1	Experimental	I-040302 doses of up to 1 mg, 2 mg or 4 mg of TGplPTH1-34	Drug: I-040302
2	Active Comparator	Standard of care (bone marrow aspirate or steroids)	Other: Standard of Care

Name	Type	Description	Arm Group Labels	Other Names
I-040302	Drug	doses of up to 1 mg, 2 mg or 4 mg of TGplPTH1-34	1
Standard of Care

Measure	Description	Time Frame
Radiographic images		At 6 months and throughout the study

Measure	Description	Time Frame
Blood parameters		At 6 months and throughout the study
Vital signs		At 6 months and throughout the study
Questionnaires of life questionnaire

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003560	Cysts
D009369	Neoplasms
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

ID	Term
D059039	Standard of Care
D013256	Steroids

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation