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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00745550




Registration number
NCT00745550
Ethics application status
Date submitted
2/09/2008
Date registered
3/09/2008
Date last updated
20/04/2012

Titles & IDs
Public title
A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis
Scientific title
A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis
Secondary ID [1] 0 0
SB1518-2008-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myelofibrosis 0 0
Myeloproliferative Disorders 0 0
Polycythemia Vera 0 0
Essential Thrombocythemia 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Leukaemia - Acute leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SB1518

Treatment: Drugs: SB1518
SB1518 taken orally daily for 28 consecutive days in a 28-day cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1: to establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily
Timepoint [1] 0 0
Throughout the study
Primary outcome [2] 0 0
Phase 2: to assess the clinical benefit rate in subjects with CIMF who are treated with SB1518 at the recommended dose
Timepoint [2] 0 0
Throughout the study
Secondary outcome [1] 0 0
Assess the safety and tolerability of SB1518, administered orally once daily in subjects with CIMF
Timepoint [1] 0 0
Throughout the study
Secondary outcome [2] 0 0
Assess the pharmacokinetic profile of SB1518
Timepoint [2] 0 0
Throughout the study
Secondary outcome [3] 0 0
Assess the pharmacodynamic profile of SB1518
Timepoint [3] 0 0
Throughout the study

Eligibility
Key inclusion criteria
Inclusion Criteria

- Subjects with CIMF (including post ET/PV MF) requiring therapy, including:

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Men of reproductive potential who can agree to practice effective contraception during
the entire study period and for one month after the last study treatment

- Women of child-bearing potential who have a negative pregnancy test within 14 days
prior to the first dose of study drug and can agree to practice effective
contraception during the entire study period and for one month after the last study
treatment, unless documentation of infertility exists

- Subjects who are able to understand and willing to sign the informed consent form
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Subjects with uncontrolled inter-current illness including, but not limited to,
ongoing active infection, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements as judged by treating physician. Subjects
receiving antibiotics for infections that are under control may be included in the
study unless the antibiotic is a CYP3A4 inducer/inhibitor

- Subjects known to be HIV-positive

- Subjects with known active hepatitis A, B, or C, or latent hepatitis B

- Women who are pregnant or lactating

- Subjects with prior radiation therapy to more than 20% of the hematopoietic marrow
(prior radiation to spleen is allowed)

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
3002 - Melbourne
Recruitment postcode(s) [2] 0 0
3050 - Melbourne
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
S*BIO
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study consists of two phases: The first portion of the study is a Phase 1 dose escalation
study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when
given as a single agent orally once daily in subjects with Chronic Idiopathic Myelofibrosis
(CIMF) regardless of their JAK2 mutational status. The second portion of the study is a Phase
2 study to define the efficacy and safety profile of single agent SB1518 at the recommended
dose in subjects with CIMF.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00745550
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Seymour, M.D.
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00745550