Phase I/II BNC105P combination study in partially platinum sensitive ovarian cancer patients in first or second relapse

Phase 1

Completed

• Conditions: Ovarian cancer; Cancer - Ovarian and primary peritoneal

• Registration Number: ACTRN12612000522819
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 134

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase I = recommended dose of BNC105P based on acceptable number of dose limiting toxicities as outlined in protocol[22 days after last patient has completed treatment with each dose];Phase II = Overall Response Rate as determined by RECIST and/or GCIG criteria for CA125 response[After a minimum of 12 months follow up has been completed for all patients]

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS) and overall survival (OS)[After a minimum of 12 months follow up has been completed for all patients];Adverse event rates graded according to the Common Terminology Criteria for Adverse Events (CTCAE)[30-42 days after last dose];Effects on aspects of health related quality of life (HRQL measured with FOSI and MOST)[30-42 days after last dose]