Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000459527
Ethics application status
Approved
Date submitted
18/10/2006
Date registered
2/11/2006
Date last updated
15/01/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase I Open-Label, Single Dose, Dose Escalation Study of KB002, a Chimeric Monoclonal Antibody Which Binds to GM-CSF (Granulocyte Macrophage Colony Stimulating Factor), in Patients with Chronic Idiopathic Thrombocytopenia Purpura (ITP)
Scientific title
A Phase I Open-Label, Single Dose, Dose Escalation Study to investigate the safety and tolerability of KB002, a Chimeric Monoclonal Antibody Which Binds to GM-CSF (Granulocyte Macrophage Colony Stimulating Factor), in Patients with Chronic Idiopathic Thrombocytopenia Purpura (ITP)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Thrombocytopenia Purpura (ITP) 1434 0
Condition category
Condition code
Blood 1530 1530 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive a single intravenous infusion of KB002. The first 6 patients will be assigned to Dose Level 1 (0.2 mg/kg). If there are no dose limiting toxicities (DLTs) during the first 7 days after their infusion, the next 6 patients will be assigned to Dose level 2 (1.0 mg/kg). If there are no DLTs during the first 7 days after their infusion, the next 6 patients will be assigned to the final Dose Level 3 (5.0 mg/kg). If a DLT occurs in any dose level then an additional 3 patients will be assigned to that dose level. Dose escalation can only occur if there are no further DLTs in the additional 3 patients.
Intervention code [1] 1409 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Dose comparison

Outcomes
Primary outcome [1] 2114 0
To investigate the safety and tolerability profile of KB002 in patients with chronic ITP. Safety assessments include: physical examination, vital signs, (Electrocardiograph) ECG, pulmonary function tests, haematology, biochemistry, urinalysis, laboratory tests and recording of adverse events. Follow up assessments include pulmonary function tests and laboratory tests.
Timepoint [1] 2114 0
Safety assessments will be performed at Days 1, 8, 15 and 29. Follow up assessments will be performed at Days 60, 90 and 120.
Secondary outcome [1] 3655 0
1. To evaluate the preliminary efficacy of KB002.
Timepoint [1] 3655 0
At Days 1, 3, 8, 15 and 29. This will be measured by evaluating platelet count results at these timepoints.
Secondary outcome [2] 3656 0
2. To investigate the preliminary pharmacokinetics of KB002.
Timepoint [2] 3656 0
At Days 1, 3, 8, 15, 29 and 60. These will be measured by blood tests to evaluate blood serum levels of KB002 at these time points.
Secondary outcome [3] 3657 0
3.To investigate the potential immunogenicity of KB002
Timepoint [3] 3657 0
At Days 29, 60, 90 and 120. This will be measured by performing blood test to measure blood plasma levels of Human Anti Chimeric Antibody (HACA).

Eligibility
Key inclusion criteria
1. Willing and able to give written informed consent 2. Chronic idiopathic thrombocytopenic purpura (ITP) for at least 6 months 3. Platelet count <30 x 109/L for patients not receiving corticosteroids; < 50 x 109/L for patients receiving a stable dose of corticosteroids (i.e., the dose has not increased or decreased within 4 weeks of Day 1).
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Treatment with cyclophosphamide, vincristine, rituximab, any other monoclonal antibody or an investigational drug within 12 weeks of Day 12. Treatment with intravenous immunoglobulin (IVIG) or intravenous Rh(D) immune globulin within 4 weeks of Day 13. Treatment with any other agent for the treatment of ITP within 4 weeks of Day 1, other than a stable dose of corticosteroids (i.e., the dose has not increased or decreased within 4 weeks of Day 1)4. Vaccination within 4 weeks of Day 15. Any of the following laboratory parameters:• WBC = 3.5 x 109/L or neutrophil count = 2.0 x 109/L• Creatinine = 2 mg/dL• Total bilirubin = 2 mg/dL• Alanine transaminase (ALT) and/or aspartate transaminase (AST) = 3 times the upper limit of normal (ULN)6. PaO2 = 95% on room air by pulse oximetry7. Major surgery, including splenectomy, within 8 weeks of Day 18. Females who are pregnant or breastfeeding9. Males or females unable to practice effective methods of birth control for 3 months after the infusion of study drug10. Current or past history of severe cardiac disease (NYHA grade III or IV, defined in Appendix B)11. Current respiratory disease or a past history of chronic respiratory disease12. Active hemolysis that requires red blood cell transfusion within 6 weeks of study entry13. History of drug-induced thrombocytopenia, marrow failure syndrome, such as aplastic anemia or myelodysplasia, or thrombocytopenia related to viral or bacterial infection14. Immune deficiency, chronic infection or chronic inflammatory condition (e.g., positive for hepatitis B surface antigen [HBsAg], hepatitis C virus [HCV] or human immunodeficiency virus [HIV], history of tuberculosis [TB], or systemic lupus erythematosus [SLE])15. History of solid or hematologic malignancy in the past 10 years, other than basal cell or non invasive squamous cell carcinoma16. Any other illness or condition that in the opinion of the investigator would be considered a high risk for participation in an investigational study, such as uncontrolled and/or clinically significant neurologic, hematologic, metabolic, endocrine, gastrointestinal, hepatic or renal disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Three cohort dose escalation
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
15/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
27
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1669 0
Commercial sector/Industry
Name [1] 1669 0
KaloBios Pharmaceuticals Inc
Country [1] 1669 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
KaloBios Pharmaceuticals Inc
Address
3427 Hillview Ave., Suite 200
Palo Alto, CA 94304
Country
United States of America
Secondary sponsor category [1] 1472 0
Commercial sector/Industry
Name [1] 1472 0
Novotech (Australia) Pty Ltd
Address [1] 1472 0
Level 3, 19 Harris Street
Pyrmont NSW 2009
Country [1] 1472 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3110 0
Royal Melbourne Hospital
Ethics committee address [1] 3110 0
Ethics committee country [1] 3110 0
Australia
Date submitted for ethics approval [1] 3110 0
16/10/2006
Approval date [1] 3110 0
21/02/2007
Ethics approval number [1] 3110 0
Ethics committee name [2] 3111 0
Box Hill Hospital
Ethics committee address [2] 3111 0
Ethics committee country [2] 3111 0
Australia
Date submitted for ethics approval [2] 3111 0
19/04/2007
Approval date [2] 3111 0
24/05/2007
Ethics approval number [2] 3111 0
Ethics committee name [3] 3112 0
Prince of Wales Hospital
Ethics committee address [3] 3112 0
Ethics committee country [3] 3112 0
Australia
Date submitted for ethics approval [3] 3112 0
Approval date [3] 3112 0
Ethics approval number [3] 3112 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27343 0
Address 27343 0
Country 27343 0
Phone 27343 0
Fax 27343 0
Email 27343 0
Contact person for public queries
Name 10598 0
Carolyn Stewart
Address 10598 0
1 Dow Street
South Melbourne VIC 3205
Country 10598 0
Australia
Phone 10598 0
03 9696 9393
Fax 10598 0
03 9696 9394
Email 10598 0
carolyn10@iinet.net.au
Contact person for scientific queries
Name 1526 0
Susan E Light
Address 1526 0
KaloBios Pharmaceuticals Inc
3427 Hillview Avenue, Suite 200
Palo Alto, CA 94304
Country 1526 0
United States of America
Phone 1526 0
0011-650-843-1897, ext. 304
Fax 1526 0
0011-650-843-1896
Email 1526 0
slight@kalobios.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
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Documents added automatically
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