B2P2M2: Phase II trial of BNC105P as 2nd line chemotherapy for advanced malignant pleural mesothelioma
B2P2M2: Phase II, single arm trial to evaluate the response rate of BNC105P as 2nd line chemotherapy for advanced malignant pleural mesothelioma
University of Sydney
60 participants
Jul 14, 2010
Interventional
Conditions
Summary
At present there is no standard 2nd line chemotherapy regime for patients with advanced malignant pleural mesothelioma (MPM) who progress after treatment with standard first line chemotherapy (i.e. pemetrexed and a platinum compound). BNC105P is a novel chemotherapy agent which has shown activity in MPM. In this study, BNC105P will be studied in a single arm, 2 stage, multi-centre design to determine its efficacy and safety as 2nd line chemotherapy for patients with MPM. All subjects will receive BNC105P on Day 1 and Day 8 of a 21 day cycle until unacceptable toxicity or disease progression. The primary endpoint will be tumour response, and secondary endpoints include progression-free survival, overall survival, adverse events, and quality of life. Correlative substudies will examine associations between potential biological markers and outcomes.
Eligibility
Inclusion Criteria9
- Confirmed diagnosis of malignant pleural mesothelioma.
- Progression after first line chemotherapy with pemetrexed and a platinum (cisplatin and/or carboplatin).
- Evidence of measurable disease as per RECIST modified for mesothelioma.
- Performance status of ECOG 0-1.
- Adequate hepatic, renal and haematological function.
- Adequate cardiac function as assessed by Left ventricular ejection fraction (LVEF) and corrected QT interval (QTc).
- Patient is able and willing to complete the Quality of Life (QOL) questionnaires, or unable due to illiteracy or visual impairment. Inability to complete the questionnaires will not exclude the patient from the study.
- Patient is willing and able to comply with treatment and follow up.
- Written informed consent.
Exclusion Criteria7
- Any prior chemotherapy other than pemetrexed and a platinum compound.
- Chemotherapy within 20 days, radiotherapy within 14 days, major surgery within 28 days
- Known brain or leptomeningeal disease
- History of another malignancy within 5 years prior to registration
- Untreated and/or uncontrolled cardiovascular conditions
- Stroke, venous or arterial blood clots within 12 months prior to registration.
- Poorly controlled hypertension
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Interventions
All patients enrolled in the study will receive the same treatment consisting of BNC105P at a dose of 16mg/m^2 given intravenously over 10 minutes on days 1 and 8 of a 21 day cycle, repeated until progression or prohibitive toxicity.
Locations(1)
View Full Details on ANZCTR
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ACTRN12610000093088