CAP7.1 for the Treatment of Advanced Stage, Therapy Refractory Lung and Biliary Tract Tumors
Conditions
Advanced Endstage Solid Carcinomas in Adults
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Small Cell Lung Carcinoma
Conditions: Keywords
therapy refractory, endstage, solid tumours
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: CAP7.1
Type: Drug
Overall Status
Recruiting
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 NSCLC, SCLC or biliary cancer who have progressed despite one or more previous chemotherapy line.
Detailed Description
A phase II evaluation will be performed in adult patients in parallel studies in 3 tumor types: NSCLC, SCLC and Biliary Tract Cancer. All patients will have advanced or metastatic disease with primary or secondary resistance to standard therapy. In each tumor type the patients will be randomized to receive either therapy with CAP7.1 or best supportive care according to institution standards. Patient in the Control group who progress may cross over to CAP7.1, however these patients will be analyzed separately from the patients randomized to CAP7.1.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
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
Location
Charite, University Hospital
Berlin, Germany
Status: Recruiting
Contact: Ulrich F Pape, MD. - +49-(0)30-450 665 209 - Ulrich-Ulrich-Frank.Pape@charite.de
Start Date
November 2011
Completion Date
December 2015
Sponsors
CellAct Pharma GmbH
Source
CellAct Pharma GmbH
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page