BNC105P Combination Study in Partially Platinum Sensitive Ovarian Cancer Patients

• Status: Withdrawn
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoosier Cancer Research Network
• Collaborators: Australia New Zealand Gynaecological Oncology Group; Bionomics Limited; University of Sydney
• Treatments: Carboplatin; Gemcitabine

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