Trial Review

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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
Trial website
Trial related presentations / publications
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

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01624493