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Trial registered on ANZCTR


Registration number
ACTRN12610000093088
Ethics application status
Approved
Date submitted
22/01/2010
Date registered
27/01/2010
Date last updated
21/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
B2P2M2: Phase II trial of BNC105P as
2nd line chemotherapy for
advanced malignant pleural mesothelioma
Scientific title
B2P2M2: Phase II, single arm trial to evaluate the response rate of BNC105P as 2nd line chemotherapy for advanced malignant pleural mesothelioma
Secondary ID [1] 1340 0
nil
Universal Trial Number (UTN)
Trial acronym
B2P2M2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced malignant pleural mesothelioma 256652 0
Condition category
Condition code
Cancer 256813 256813 0 0
Lung - Mesothelioma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients enrolled in the study will receive the same treatment consisting of BNC105P at a dose of 16mg/m^2 given intravenously over 10 minutes on days 1 and 8 of a 21 day cycle, repeated until progression or prohibitive toxicity.
Intervention code [1] 255889 0
Treatment: Drugs
Comparator / control treatment
This is a single arm study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257676 0
Objective tumour response rate (complete response (CR) or partial response (PR) with Response Evaluation Criteria In Solid Tumour (RECIST) modified for mesothelioma)
Timepoint [1] 257676 0
Tumour assessments are performed at baseline, then at weeks 6, 12, 18, 24 and then 12 weekly until progression
Secondary outcome [1] 262987 0
Progression-free survival (PFS, progression or death) as assessed by computed tomography (CT) scan using RECIST modified for mesothelioma
Timepoint [1] 262987 0
Tumour assessments are performed at baseline, then at weeks 6, 12, 18, 24 and then 12 weekly until progression.
Secondary outcome [2] 262988 0
Treatment duration (TD, interval from first dose to last dose)
Timepoint [2] 262988 0
Clinic visits are 3-weekly during treatment.
Secondary outcome [3] 262989 0
Adverse events e.g. fatigue, nausea, lowering of blood counts. Adverse events will be assessed using physical examination, blood tests, and asking the patient about their health since the last assessment. Adverse Events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0)
Timepoint [3] 262989 0
Adverse events are assessed at baseline, every 3 weeks during treatment, and 30-42 days after the last treatment dose.
Secondary outcome [4] 262990 0
Health-related quality of life (using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Cancer 30 questions (QLQ-C30), Quality of Life Module - Lung 13 questions (QLM-L13), and Patient Data Form (PDF)).
Timepoint [4] 262990 0
Quality of life questionaires are completed at baseline, every 3 weeks during treatment, and 30-42 days after the last treatment dose.
Secondary outcome [5] 262991 0
Changes in spirometric lung function tests (Forced expiratory volume in one second (FEV1) and Forced vital capacity (FVC)).
Timepoint [5] 262991 0
Spirometric lung function tests are completed at baseline, every 3 weeks during treatment, and 30-42 days after the last treatment dose.
Secondary outcome [6] 262992 0
Overall survival (OS, death from any cause, as assessed by clinic visits and information available in the patient's medical record).
Timepoint [6] 262992 0
Clinic visits are 3-weekly during treatment, then follow up visits are 12-weekly until 12 months after the last patient has entered the study.

Eligibility
Key inclusion criteria
1. Confirmed diagnosis of malignant pleural mesothelioma.
2. Progression after first line chemotherapy with pemetrexed and a platinum (cisplatin and/or carboplatin).
3. Evidence of measurable disease as per RECIST modified for mesothelioma.
4. Performance status of ECOG 0-1.
5. Adequate hepatic, renal and haematological function.
6. Adequate cardiac function as assessed by Left ventricular ejection fraction (LVEF) and corrected QT interval (QTc).
7. Patient is able and willing to complete the Quality of Life (QOL) questionnaires, or unable due to illiteracy or visual impairment. Inability to complete the questionnaires will not exclude the patient from the study.
8. Patient is willing and able to comply with treatment and follow up.
9. Written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any prior chemotherapy other than pemetrexed and a platinum compound.
2. Chemotherapy within 20 days, radiotherapy within 14 days, major surgery within 28 days
3. Known brain or leptomeningeal disease
4. History of another malignancy within 5 years prior to registration
5. Untreated and/or uncontrolled cardiovascular conditions
6. Stroke, venous or arterial blood clots within 12 months prior to registration.
7. Poorly controlled hypertension

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)
Patients will be enrolled through the Australasian Lung Trials Group (ALTG) Coordinating Centre, National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a single arm study
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/07/2010
Actual
14/07/2010
Date of last participant enrolment
Anticipated
Actual
27/04/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,SA,WA

Funding & Sponsors
Funding source category [1] 256376 0
Commercial sector/Industry
Name [1] 256376 0
Bionomics Ltd
Country [1] 256376 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country
Australia
Secondary sponsor category [1] 251688 0
None
Name [1] 251688 0
Address [1] 251688 0
Country [1] 251688 0
Other collaborator category [1] 1054 0
Other Collaborative groups
Name [1] 1054 0
Australasian Lung Trials Group (ALTG)
Address [1] 1054 0
ALTG Coordinating Centre
Locked Bag 77
Camperdown NSW 1450
Country [1] 1054 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258441 0
Cancer Institute NSW Clinical Research Ethics Committee
Ethics committee address [1] 258441 0
Cancer Institute NSW, Australian Technology Park, Suite 101, 1 Central Avenue, Eveleigh, NSW 2015
Ethics committee country [1] 258441 0
Australia
Date submitted for ethics approval [1] 258441 0
17/11/2009
Approval date [1] 258441 0
28/01/2010
Ethics approval number [1] 258441 0
2009c/12/117

Summary
Brief summary
At present there is no standard 2nd line chemotherapy regime for patients with advanced malignant pleural mesothelioma (MPM) who progress after treatment with standard first line chemotherapy (i.e. pemetrexed and a platinum compound). BNC105P is a novel chemotherapy agent which has shown activity in MPM. In this study, BNC105P will be studied in a single arm, 2 stage, multi-centre design to determine its efficacy and safety as 2nd line chemotherapy for patients with MPM. All subjects will receive BNC105P on Day 1 and Day 8 of a 21 day cycle until unacceptable toxicity or disease progression. The primary endpoint will be tumour response, and secondary endpoints include progression-free survival, overall survival, adverse events, and quality of life. Correlative substudies will examine associations between potential biological markers and outcomes.
Trial website
Trial related presentations / publications
A.K. Nowak, C. Brown, M.J. Millward, J. Creaney, M.J. Byrne, B. Hughes et al. A phase II clinical trial of the Vascular Disrupting Agent BNC105P as second line chemotherapy for advanced Malignant Pleural Mesothelioma. Lung Cancer, 81 (2013), pp. 422-427.
Public notes

Contacts
Principal investigator
Name 30750 0
Dr Anna Novak
Address 30750 0
c/o NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW 1450
Country 30750 0
Australia
Phone 30750 0
+61 2 9562 5000
Fax 30750 0
Email 30750 0
[email protected]
Contact person for public queries
Name 13997 0
Helen Taylor
Address 13997 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 13997 0
Australia
Phone 13997 0
+61 2 9562 5000
Fax 13997 0
Email 13997 0
[email protected]
Contact person for scientific queries
Name 4925 0
Prof Martin Stockler
Address 4925 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 4925 0
Australia
Phone 4925 0
+61 2 9562 5000
Fax 4925 0
Email 4925 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseThe development and use of vascular targeted therapy in ovarian cancer.2017https://dx.doi.org/10.1016/j.ygyno.2017.01.031
EmbaseCytotoxic stilbenes and derivatives as promising antimitotic leads for cancer therapy.2018https://dx.doi.org/10.2174/1381612825666190111123959
N.B. These documents automatically identified may not have been verified by the study sponsor.