CAP7.1 for the Treatment of Advanced Stage, Therapy Refractory Lung and Biliary Tract Tumors

• Status: Terminated
• Trial end date: 2017-04-10
• Target enrollment: 0
• Participant gender: All

Summary

To assess the anti-tumor activity of CAP7.1 based on the observed objective response rate and rate of disease stabilization, as defined by the below primary and secondary endpoints, in patients with Non-Small Cell Lung Carcinoma (NSCLC), SCLC or biliary cancer who have progressed despite one or more previous chemotherapy line.

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

Details

• Lead Sponsor: CellAct Pharma GmbH
• Collaborator: Mundipharma-EDO GmbH

Criteria

Inclusion Criteria:

• Histologically- or cytologically-confirmed, advanced disease with documented progression (RECIST1.1.) after one or several chemotherapy line

• Patients may also have received molecular targeted therapy and progressed while on therapy or after completion

• Must have recovered from the acute reversible effects of previous anti-cancer chemotherapy, usually 3-4 weeks after myelosuppressive chemotherapy

Exclusion Criteria:

• Serious concurrent medical condition, which could affect compliance with the protocol or interpretation of results.

• Patients with uncontrolled infection and patients known to be infected with the human immunodeficiency virus (HIV) or hepatitis infection are not eligible for the study

• Pregnancy or breast-feeding