B2P2M2: Phase II trial of BNC105P as 2nd line chemotherapy for advanced malignant pleural mesothelioma

Phase 2

Completed

• Conditions: Advanced malignant pleural mesothelioma; Cancer - Lung - Mesothelioma

• Registration Number: ACTRN12610000093088
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Confirmed diagnosis of malignant pleural mesothelioma.
2. Progression after first line chemotherapy with pemetrexed and a platinum (cisplatin and/or carboplatin).
3. Evidence of measurable disease as per RECIST modified for mesothelioma.
4. Performance status of ECOG 0-1.
5. Adequate hepatic, renal and haematological function.
6. Adequate cardiac function as assessed by Left ventricular ejection fraction (LVEF) and corrected QT interval (QTc).
7. 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.
8. Patient is willing and able to comply with treatment and follow up.
9. Written informed consent.

Exclusion Criteria

1. Any prior chemotherapy other than pemetrexed and a platinum compound.
2. Chemotherapy within 20 days, radiotherapy within 14 days, major surgery within 28 days
3. Known brain or leptomeningeal disease
4. History of another malignancy within 5 years prior to registration
5. Untreated and/or uncontrolled cardiovascular conditions
6. Stroke, venous or arterial blood clots within 12 months prior to registration.
7. Poorly controlled hypertension

Study & Design

• Study Type: Interventional
• Study Design: Not specified