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

CellAct Pharma

Status and phase: Terminated; Phase 2

Conditions: Advanced Endstage Solid Carcinomas in Adults

Treatments: Drug: CAP7.1

Study type: Interventional

Funder types: Industry

Identifiers

NCT02094560

2012-002378-30 (EudraCT Number)

CPN710102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

45 participants in 3 patient groups

Small cell lung cancer

Experimental group

Description:

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

Treatment:

Drug: CAP7.1

Non small cell lung cancer

Experimental group

Description:

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

Treatment:

Drug: CAP7.1

biliary tract cancer

Experimental group

Description:

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

Treatment:

Drug: CAP7.1