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Trial registered on ANZCTR


Registration number
ACTRN12612000522819
Ethics application status
Approved
Date submitted
2/04/2012
Date registered
16/05/2012
Date last updated
13/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase I/II BNC105P combination study in partially platinum sensitive ovarian cancer patients in first or second relapse
Scientific title
Phase I/II BNC105P combination study, evaluating recommended dose of BNC105P and objective response rate, in partially platinum sensitive ovarian cancer patients in first or second relapse
Secondary ID [1] 280266 0
ANZGOG-1103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian cancer 286214 0
Condition category
Condition code
Cancer 286428 286428 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase I: Carboplatin AUC 4 day 1 given IV over 60 minutes, Gemcitabine escalations 800 and 1000 mg/m2 days 1 and 8, given IV over 30 minutes, BNC105P escalations at 8, 12 or 16mg/m2 days 2 and 9, given IV over 10 minutes, all every 21 days, for 6 cycles, followed by single agent maintenance BNC105P for a maximum of 6 additional cycles at 16 mg/m2 on days 2 and 9.
Phase II: Carboplatin AUC 4 day 1 IV over 60 minutes, Gemcitabine 800 or 1000 mg/m2 days 1 and 8 IV over 30 minutes as determined in the Phase I component, given with OR without BNC105P at previously defined MTD on days 2 and 9, all every 21 days for 6 cycles, followed by a maximum of 6 cycles of single agent BNC105P at 16 mg/m2.
Intervention code [1] 284615 0
Treatment: Drugs
Comparator / control treatment
Phase I: single arm dose finding study

Phase II comparator: Carboplatin AUC 4 on day 1, gemcitabine 800 or 1000 mg/m2 on days 1 and 8 of a 21 day cycle for a maximum of 6 cycles.
Control group
Active

Outcomes
Primary outcome [1] 286871 0
Phase I = recommended dose of BNC105P based on acceptable number of dose limiting toxicities as outlined in protocol
Timepoint [1] 286871 0
22 days after last patient has completed treatment with each dose
Primary outcome [2] 286872 0
Phase II = Overall Response Rate as determined by RECIST and/or GCIG criteria for CA125 response
Timepoint [2] 286872 0
After a minimum of 12 months follow up has been completed for all patients
Secondary outcome [1] 296872 0
Progression free survival (PFS) and overall survival (OS)
Timepoint [1] 296872 0
After a minimum of 12 months follow up has been completed for all patients
Secondary outcome [2] 296873 0
Adverse event rates graded according to the Common Terminology Criteria for Adverse Events (CTCAE)
Timepoint [2] 296873 0
30-42 days after last dose
Secondary outcome [3] 296874 0
Effects on aspects of health related quality of life (HRQL measured with FOSI and MOST)
Timepoint [3] 296874 0
30-42 days after last dose

Eligibility
Key inclusion criteria
Phase I only
1. Histologically or cytologically proven diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, including all histological subtypes and carcinosarcoma.
2. Progression-free interval > 4 months (as per GCIG definition of progression) after first or second line platinum (cisplatin or carboplatin) based chemotherapy.
3. Performance status of ECOG 0-1.

Phase II only
1. Histologically proven diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.
2. Progression-free interval between 4 to 9 months after first line chemotherapy or 4 to 12 months after second-line chemotherapy with a platinum (cisplatin or carboplatin) based regimen.
3. Subjects must have progressed (based on GCIG CA125 and/or RECIST criteria) after last platinum based regimen
4. Subjects must be assessable for response based on GCIG CA125 and/or RECIST criteria.
5. Subjects with clinically evident ascites and/or pleural effusions must be assessable by RECIST.
6. If the calculated GFR is 50 - 54 ml/min an isotopic GFR may be performed. If the isotopic GFR is > 55ml/min, the patient will be eligible for the study but the calculated GFR will be used for dose calculation.
7. Performance status of ECOG 0-2
8. Study treatment both planned and able to start within 7 days of randomisation
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Phase II only
1. Carcinosarcoma and mucinous carcinoma

Phase I and II
1. Non-epithelial ovarian cancer and ovarian tumours of low malignant potential (borderline tumours)
2. More than two prior chemotherapy regimens for ovarian cancer (excluding hormonal therapy or biologic agents).
3. Any prior chemotherapy for other cancers, but >10 years permitted for phase II only, except for high dose chemotherapy/autologous or allogeneic transplantation
4. Chemotherapy within 20 days prior to registration.
5. Hormonal therapy or biologic therapy within 28 days prior to registration
6. Concurrent treatment with any experimental drugs or other anti-cancer therapy.
7. Concurrent treatment with clopidogrel, ticlopidine, persantin and other antiplatelet agents
8. Radiotherapy within 21 days prior to registration, or to greater than 15% of the bone marrow.
9. Persistent toxic effects of previous chemotherapy of greater than grade 1 severity

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)
Phase I Nonrandomised. Allocation to dosing levels in consultation with Trial Steering Committee

Phase 2 Central randomisation by computer
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
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD
Recruitment outside Australia
Country [1] 4236 0
United States of America
State/province [1] 4236 0
Indiana

Funding & Sponsors
Funding source category [1] 285028 0
Commercial sector/Industry
Name [1] 285028 0
Bionomics Ltd
Address [1] 285028 0
31 Dalgleish Street
Thebarton SA 5031
Country [1] 285028 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] 283892 0
None
Name [1] 283892 0
Address [1] 283892 0
Country [1] 283892 0
Other collaborator category [1] 260696 0
Other Collaborative groups
Name [1] 260696 0
Australia New Zealand Gynaecological Oncology Group
Address [1] 260696 0
Locked Bag 77
Camperdown
NSW 1450
Country [1] 260696 0
Australia
Other collaborator category [2] 260697 0
Other Collaborative groups
Name [2] 260697 0
Hoosier Oncology Group
Address [2] 260697 0
351 W. 10th Street, Suite 330
Indianapolis, IN 46202
Country [2] 260697 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287030 0
Cancer Institute NSW Clinical Research Ethics Committee
Ethics committee address [1] 287030 0
Cancer Institute NSW
PO Box 41
Alexandria NSW 1435
Ethics committee country [1] 287030 0
Australia
Date submitted for ethics approval [1] 287030 0
Approval date [1] 287030 0
24/02/2012
Ethics approval number [1] 287030 0
2011C/12/178
Ethics committee name [2] 295465 0
Sydney Local Health District Human Research Ethics Committee
Ethics committee address [2] 295465 0
Suite 210, RPA Medical Centre
Carilon Avenue
Camperdown NSW 2050
Ethics committee country [2] 295465 0
Australia
Date submitted for ethics approval [2] 295465 0
14/08/2013
Approval date [2] 295465 0
19/08/2013
Ethics approval number [2] 295465 0
X13-0158 & HREC/13/RPAH/317

Summary
Brief summary
This study will evaluate the effect of combining standard chemotherapy with the drug, BNC105P, for the treatment of partially platinum sensitive ovarian cancer. Who is it for? You may be eligible to join this study if you are a female aged 18years or above and have a diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, for which you have undergone first or second line platinum based chemotherapy. Your cancer should not have progressed for at least 4 months following this chemotherapy. Trial details There are two parts to this study. Each participant will be involved in one part only. In part 1 of the study, participants will undergo chemotherapy with carboplatin, gemcitabine, and BNC105P for up to 6 cycles (each cycle is 21 days). Subsequent patients will receive escalating doses of these drugs in order to determine the maximum tolerated dose. Participants will then undergo a further 6 cycles of maintenance therapy with BNC105P only. Participants enrolled in part 2 of this study will be randomly (by chance) allocated to one of two groups. Both groups will undergo standard chemotherapy with Carboplatin and Gemcitabine for 6 cycles (each cycle is 21 days). However, one group will also receive the maximum tolerated dose (determined in part 1 of the study) of BNC105P during these cycles. Both groups will then undergo a maximum of 6 cycles of maintenance therapy with BNC105P. Participants in both parts of the study will be assessed at regular intervals in order to evaluate the safety of treatment, response rate, and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34013 0
Prof Danny Rischin
Address 34013 0
Peter MacCallum Cancer Centre
2 St Andrews Place, East Melbourne VIC 3002
Country 34013 0
Australia
Phone 34013 0
+61 3 9656 1111
Fax 34013 0
Email 34013 0
danny.rischin@petermac.org
Contact person for public queries
Name 17260 0
Dr ANZGOG trials
Address 17260 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW 1450
Country 17260 0
Australia
Phone 17260 0
+61 2 9562 5000
Fax 17260 0
+61 2 9562 5094
Email 17260 0
anzgog1103@ctc.usyd.edu.au
Contact person for scientific queries
Name 8188 0
Dr ANZGOG trials
Address 8188 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW 1450
Country 8188 0
Australia
Phone 8188 0
+61 2 9562 5000
Fax 8188 0
+61 2 9562 5094
Email 8188 0
anzgog1103@ctc.usyd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary