BNC105P Combination Study in Partially Platinum Sensitive Ovarian Cancer Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 4 January 2016
• Main ID: NCT01624493
• Date of registration: 15/06/2012
• Prospective Registration: Yes
• Primary sponsor: Hoosier Cancer Research Network
• 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
• Date of first enrolment: October 2012
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT01624493
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Australia, New Zealand, United States

Contacts

• Name: Daniela Matei, M.D.
• Affiliation: Hoosier Cancer Research Network

• Name: Danny Rischin, Professor
• Affiliation: University of Sydney

Key inclusion & exclusion 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

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Ovarian Cancer

Intervention(s)

Drug: BNC105P

Drug: Gemcitabine

Drug: Carboplatin

Primary Outcome(s)

Phase II: Determine Objective Response Rate in Patients [Time Frame: 12 months]

Phase I: Determine Maximum Tolerated Dose for Patients [Time Frame: 12 months]

Secondary Outcome(s)

Association of Biomarkers, Predictions and Outcomes [Time Frame: 12 months]

Assessment of BNC105P Pharmacokinetics to Determine Interaction with Carboplatin and Gemcitabine [Time Frame: 12 months]

Patient Quality of Life Benefits [Time Frame: 12 months]

Patient Side Effects and Tolerability [Time Frame: 12 months]

Progression Free and Overall Survival Distribution [Time Frame: 12 months]

Secondary ID(s)

GYN12-154 / ANZGOG-1103

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Australia New Zealand Gynaecological Oncology Group

Bionomics Limited

University of Sydney