Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000520437
Ethics application status
Approved
Date submitted
3/10/2007
Date registered
10/10/2007
Date last updated
5/07/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1, Two-Stage, Dose-Escalation Study of BNC105P, a Novel Vascular Disrupting Agent, in Patients with Advanced Solid Tumors
Scientific title
A Phase 1, Two-Stage, Dose-Escalation Study of BNC105P, a Novel Vascular Disrupting Agent, in Patients with Advanced Solid Tumors
Secondary ID [1] 252154 0
BNC105P.001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid tumours 2420 0
Condition category
Condition code
Cancer 2526 2526 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two-stage dose escalation study involving intravenous administration of BNC105P on days 1 and 8 of a 21-day cycle. Stage 1 enrolls 1 patient per cohort and commences at 2.3 mg/m2 with 100% increments until significant toxicities are observed (adverse events graded at 2 or higher within the first 21-day cycle). Stage 2 enrolls 3 or more patients per cohort, beginning at the dose level where significant toxicities are observed in Stage 1 and dose increments are either 33%, 50% or 100% depending upon the incidence of adverse events (2 or more, 1, or no patients with adverse events, respectively).
Intervention code [1] 2152 0
Treatment: Drugs
Comparator / control treatment
No Comparator or control tratment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3425 0
To determine the safety, toxicity profile, and maximum tolerated dose (MTD) of BNC105P in patients with advanced solid tumors
Timepoint [1] 3425 0
21 days
Secondary outcome [1] 5685 0
To determine the pharmacokinetics (PK) of BNC105 and BNC105P
Timepoint [1] 5685 0
Days 1 and 8
Secondary outcome [2] 5686 0
To demonstrate modulation of kinetic parameters directly related to vascular characteristics (changes in transfer constant [Ktrans] and initial area under gadolinium concentration-time curve [IAUGC]) using a dynamic contrast-enhanced (DCE)- magnetic resonance imaging (MRI) technique
Timepoint [2] 5686 0
24 hours
Secondary outcome [3] 5687 0
To show evidence for a dose-response relationship between either dose administered or PK parameters and DCE-MRI kinetic parameters
Timepoint [3] 5687 0
24 hours
Secondary outcome [4] 5688 0
To identify the therapeutic window (i.e., the difference between the MTD and the dose where > 1 patient in a cohort shows a significant change in DCE-MRI kinetic parameters)
Timepoint [4] 5688 0
24 hours
Secondary outcome [5] 5689 0
To obtain preliminary data on the suppression of tumor growth using standard imaging techniques
Timepoint [5] 5689 0
42 days
Secondary outcome [6] 6420 0
To evaluate prospective biomarkers of response using plasma, serum and cell associated indicators of vascular damage and repair.
Timepoint [6] 6420 0
Days 1 and 8

Eligibility
Key inclusion criteria
(i) Confirmed solid malignancy; (ii) Life-expectancy of greater than 12 weeks; (iii) No anticancer chemotherapy for the preceding 4 weeks; (iv) Adequate organ function; (v) Disease amenable to assessment by MRI; (vi) Adequate performance score (Eastern Cooperative Oncology Group score of 0-2)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Patients must not have received other experimental agents in preceding 4 weeks; (ii) Known brain disease; (iii) Patients with various cardiovascular risk factors are excluded; (iv) Pregnancy and immune deficiency; (v) Patients on full dose anticoagulants are excluded.

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
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 447 0
3050
Recruitment postcode(s) [2] 448 0
3002
Recruitment postcode(s) [3] 449 0
3011

Funding & Sponsors
Funding source category [1] 2674 0
Commercial sector/Industry
Name [1] 2674 0
Bionomics Limited
Country [1] 2674 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bionomics Limited
Address
31 Dalgleish Street
Thebarton SA 5031
Country
Australia
Secondary sponsor category [1] 2425 0
None
Name [1] 2425 0
Address [1] 2425 0
Country [1] 2425 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4601 0
Melbourne Health Human Research Ethics Committee.
Ethics committee address [1] 4601 0
Ethics committee country [1] 4601 0
Australia
Date submitted for ethics approval [1] 4601 0
03/10/2007
Approval date [1] 4601 0
05/12/2007
Ethics approval number [1] 4601 0
2007.219

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

Contacts
Principal investigator
Name 28087 0
Address 28087 0
Country 28087 0
Phone 28087 0
Fax 28087 0
Email 28087 0
Contact person for public queries
Name 11244 0
Annabell Leske
Address 11244 0
Bionomics Ltd
31 Dalgleish Street
Thebarton Sa 5031
Country 11244 0
Australia
Phone 11244 0
+61 (08) 8354 6100
Fax 11244 0
+61 (08) 8354 6199
Email 11244 0
clinicaltrials@bionomics.com.au
Contact person for scientific queries
Name 2172 0
Gabriel Kremmidiotis
Address 2172 0
Bionomics Ltd
31 Dalgleish Street
Thebarton Sa 5031
Country 2172 0
Australia
Phone 2172 0
+61 (08) 8354 6100
Fax 2172 0
+61 (08) 8354 6199
Email 2172 0
gkremmid@bionomics.com.au

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.