CD-40 activating antibody (CP-870,893) in combination with cisplatin and pemetrexed in unresectable malignant mesothelioma: a phase Ib study

Phase 1

Completed

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

• Registration Number: ACTRN12609000294257
• Lead Sponsor: Sir Charles Gairdner Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-18
• Study Completion: 2014-01-10
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

histologically or cytologically confirmed malignant pleural mesothelioma
- planned for first-line treatment with cisplatin and pemetrexed
- measurable or evaluable disease on CT (modified RECIST criteria)
- Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) 0-1
- platelets >100, neutrophils >2
- est. calculated creatinine clearance (CrCl) >/= 60ml/min
- not pregnant or breast feeding

Exclusion Criteria

- unwilling to comply with therapeutic protocol
- bilirubin > upper limit of normal (ULN), alanine transaminase (ALT) or aspartate transaminase (AST) > 2x ULN, alkaline phosphatase (ALP) > 2.5x ULN
- history of severe autoimmune disease
- prior radiotherapy to all areas of measurable disease
- prior history of thromboembolic disorder
- previous or concurrent malignancy (except curatively treated basal cell carcinoma (BCC) of skin, carcinoma-in-situ (CIS) of cervix) unless treated with curative intent >5 years before enrolment
- concomitant requirement for oral corticosteroids for >5 days of each treatment cycle
- symptomatic central nervous system (CNS) involvement

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to determine the maximum tolerated dose of CP-870,893 in combination with up to cisplatin and pemetrexed, as determined by monitoring by health care professionals and patient questionnaires.[Toxicity will be monitored weekly through patient questionnaires and by health professionals whilst receiving treatment, and at 90-day follow-up visit.]