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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01624493




Registration number
NCT01624493
Ethics application status
Date submitted
15/06/2012
Date registered
20/06/2012
Date last updated
23/12/2015

Titles & IDs
Public title
BNC105P Combination Study in Partially Platinum Sensitive Ovarian Cancer Patients
Scientific title
Phase I/II BNC105P Combination Study in Partially Platinum Sensitive Ovarian Cancer Patients in First or Second Relapse
Secondary ID [1] 0 0
GYN12-154 / ANZGOG-1103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Carboplatin
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Carboplatin
Treatment: Drugs - Gemcitabine
Treatment: Drugs - BNC105P

Experimental: Phase II Arm A - Phase II Arm A will randomize patients to treatment regimen of carboplatin and gemcitabine without BNC105P

Experimental: Phase II Arm B - Phase II Arm B will randomize patients to treatment regimen of carboplatin and gemcitabine and will include BNC105P


Treatment: Drugs: Carboplatin
Carboplatin AUC4 on day 1 of 21-day cycle, for a maximum of 6 cycles.

Treatment: Drugs: Gemcitabine
Gemcitabine escalations 800 and 1000 mg/m2 (as determined in phase I) on days 1 and 8 of a 21 day cycle, for a maximum of 6 cycles.

Treatment: Drugs: Carboplatin
Carboplatin AUC 4 on day 1 of a 21 day cycle, for a maximum of 6 cycles.

Treatment: Drugs: Gemcitabine
Gemcitabine 800 or 1000 mg/m2 (as determined in phase I) on days 1 and day 8 of 21-day cycle, for a maximum of 6 cycles.

Treatment: Drugs: BNC105P
BNC105P as determined in phase I, on days 2 and 9 of a 21 day cycle for a maximum of 6 cycles, followed by single agent maintenance BNC105P 16 mg/m2 for a maximum of 6 additional cycles.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase I: Determine Maximum Tolerated Dose for Patients
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Phase II: Determine Objective Response Rate in Patients
Timepoint [2] 0 0
12 months
Secondary outcome [1] 0 0
Progression Free and Overall Survival Distribution
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Patient Side Effects and Tolerability
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Patient Quality of Life Benefits
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Assessment of BNC105P Pharmacokinetics to Determine Interaction with Carboplatin and Gemcitabine
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Association of Biomarkers, Predictions and Outcomes
Timepoint [5] 0 0
12 months

Eligibility
Key inclusion criteria
Inclusion Criteria for Phase I Only:

* Histologically or cytologically proven diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, including all histological subtypes and carcinosarcoma.

Inclusion Criteria for Phase II Only:

* Histologically proven diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.
* 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.
* Subjects must have progressed (based on GCIG CA125 and/or RECIST criteria) after last platinum based regimen.
* Subjects must be assessable for response based on GCIG CA125 and/or RECIST criteria.
* Subjects with clinically evident ascites and/or pleural effusions must be assessable by RECIST.
* Study treatment both planned and able to start within 7 days of randomisation
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria for Phases I and II:

* Non-epithelial ovarian cancer and ovarian tumours of low malignant potential (borderline tumours)
* More than two prior chemotherapy regimens for ovarian cancer (excluding hormonal therapy or biologic agents).
* Any prior chemotherapy for other cancers, but >10 years permitted for phase II only, except for high dose chemotherapy/autologous or allogeneic transplantation
* Chemotherapy within 20 days prior to registration.
* Hormonal therapy or biologic therapy within 28 days prior to registration
* Concurrent treatment with any experimental drugs or other anti-cancer therapy.
* Concurrent treatment with clopidogrel, ticlopidine, persantin and other antiplatelet agents
* Radiotherapy within 21 days prior to registration, or to greater than 15% of the bone marrow.
* Persistent toxic effects of previous chemotherapy of greater than Grade 1 severity (CTCAE v 4, appendix 8)
* Known brain or leptomeningeal disease (baseline CT brain or MRI is only required if there is clinical suspicion of central nervous system involvement).
* Subjects with other invasive malignancies who had (or have) any evidence of another cancer present within the last 3 years, with the exception of early stage non-melanoma skin cancer, carcinoma in situ of cervix, and synchronous endometrial cancer (stage 1 G1,2)
* Untreated and/or uncontrolled cardiovascular conditions and/or symptomatic cardiac dysfunction (unstable angina, congestive cardiac failure, myocardial infarction) within the previous year, or cardiac ventricular arrhythmias requiring medication, or history of 2nd or 3rd degree atrioventricular conduction defects.
* Cerebrovascular accident or transient ischemic attack within 6 months prior to registration.
* Poorly controlled hypertension: systolic BP >150 or diastolic BP >100 mmHg. Antihypertensive medications are permitted but BP must be =150 systolic and =100 diastolic on 2 readings separated by at least 24 hours.
* Deep vein thrombosis, pulmonary embolism, within 6 months of registration or arterial thrombosis, or arterial embolism within 12 months prior to registration.
* Receiving full dose, therapeutic anti-coagulation with warfarin, related oral anti-coagulants or unfractionated or low molecular weight heparin. Low dose heparin given for prophylaxis, and aspirin at a dose = 325 mg/day is acceptable.
* Significant infection including active hepatitis B, hepatitis C with abnormal liver function tests, or HIV. Testing for these is not mandatory. Screening for Hepatitis B should be as per institutional policy. Patients known to be Hep B surface antigen positive will be not be eligible even if on antiviral treatment.
* Serious medical or psychiatric conditions which might prevent management according to the protocol.
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomisation
* Pregnancy, lactation, or inadequate contraception. Women must be post menopausal or sterile, or use two reliable means of contraception. Women of childbearing potential must have a pregnancy test taken and proven negative within 7 days prior to registration.
* Life expectancy of less than 12 weeks.

Exclusion Criteria for Phase II only:

* Carcinosarcoma and mucinous carcinoma

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2014
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
8006 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
New Zealand
State/province [3] 0 0
Canterbury

Funding & Sponsors
Primary sponsor type
Other
Name
Hoosier Cancer Research Network
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australia New Zealand Gynaecological Oncology Group
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
Bionomics Limited
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This phase I/II trial will determine the recommended dose and activity of BNC105P for patients with partially platinum sensitive ovarian cancer in first or second relapse.
Trial website
https://clinicaltrials.gov/study/NCT01624493
Trial related presentations / publications
Danny Rischin, Daniela Matei, Jeffrey C. Goh, Michelle Margaret Vaughan, Philip James Beale, Meaghan Elizabeth Tenney, Julie Martyn, Dirkje Willemien Sommeijer, Jose Luis Iglesias, David C. Bibby, Jeremy Simpson, Elizabeth E. Doolin, Corinne E. Williams, Martin R. Stockler. A phase I/II study of the vascular disrupting agent BNC105P in combination with gemcitabine-carboplatin in partially platinum-sensitive ovarian cancer patients in first or second relapse: An international collaborative group trial of ANZGOG and HOG. J Clin Oncol 31, 2013 (suppl; abstr TPS5612) http://abstracts2.asco.org/AbstView_132_108013.html
Danny Rischin, Philip James Beale, Emma Caroline Rossi, Jeffrey C. Goh, Michelle Margaret Vaughan, Meaghan Elizabeth Tenney, Julie Martyn, Dirkje Willemien Sommeijer, Jose Luis Iglesias, Gabriel Kremmidiotis, Jeremy Andrew Simpson, Elizabeth E. Doolin, Tina C. Lavranos, Annabell F. Leske, Anne-Sophie Veillard, Martin R. Stockler, ANZGOG and HOG. A phase I study of the vascular-disrupting agent BNC105P in combination with gemcitabine-carboplatin in platinum-sensitive ovarian cancer patients in first or second relapse. J Clin Oncol 32:5s, 2014 (suppl; abstr 5524^). ACTRN12612000522819
Public notes

Contacts
Principal investigator
Name 0 0
Danny Rischin, Professor
Address 0 0
University of Sydney
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/study/NCT01624493