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

Phase 2TerminatedNCT02094560

CellAct Pharma GmbH45 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Endstage Solid Carcinomas in Adults

Interventions

CAP7.1DRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Charite, University Hospital

Berlin, Germany

Outcomes

Primary Outcomes

Time to disease progression

Assessment of antitumor activity based on RECIST 1.1 criteria (complete response; partial response; stable disease)

Time frame: 18 month

Secondary Outcomes

1. Percentage of Subjects With Objective Response [i.e., complete response (CR) + partial response (PR)] According to RECIST1.1