Trial | NCT02094560  Report issue

Title

CAP7.1 for the Treatment of Advanced Stage, Therapy Refractory Lung and Biliary Tract Tumors
Phase II Trial of CAP7.1 in Adult Patients With Refractory Malignancies: Small Cell Lung Carcinoma, Non-Small Cell Lung Carcinoma, Biliary Carcinoma (PIITCAP)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    cap7.1 ...

  • Study Participants

    45
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.
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.
Study Started
Nov 08
2011
Primary Completion
Sep 08
2015
Study Completion
Apr 10
2017
Last Update
Sep 05
2018

Drug CAP7.1

CAP7.1 is a prodrug of Etoposide released after via specific carboxyesterase

Small cell lung cancer Experimental

Histologically- or cytologically-confirmed, limited and extensive SCLC disease with progression after first or second line treatment

Non small cell lung cancer Experimental

Histologically- or cytologically-confirmed diagnosis of NSCLC with Stage IIIB or IV after failure of at least two lines of therapy

biliary tract cancer Experimental

Histologically or cytologically confirmed diagnosis of biliary tract cancer progress after first line therapy

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
No Results Posted