Advanced Endstage Solid Carcinomas in Adults
Conditions
Keywords
therapy refractory, endstage, solid tumours
Brief 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.
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.
Interventions
DRUGCAP7.1
CAP7.1 is a prodrug of Etoposide released after via specific carboxyesterase
Sponsors
Mundipharma-EDO GmbH
CellAct Pharma GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to disease progression | 18 month | Assessment of antitumor activity based on RECIST 1.1 criteria (complete response; partial response; stable disease) |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Observed Drug Concentration (Cmax) of CAP7.1 in Plasma | Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months) |
| Time to Reach Maximum Drug Concentration (tmax) of CAP7.1 in Plasma | Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months) |
| Half-life Associated With the Terminal Slope (t1/2) of CAP7.1 in Plasma | Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months) |
| Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of CAP7.1 in Plasma | Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months) |
| Number of Subjects With Treatment Emergent Adverse Events (TEAEs) | Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months) |
| Time to Treatment Failure | Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months) |
| Progression-Free Survival (PFS) | Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months) |
| Disease-free survival | Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months) |
| Overall Survival (OS) | Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months) |
| 1. Percentage of Subjects With Objective Response [i.e., complete response (CR) + partial response (PR)] According to RECIST1.1 | Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months) |
Countries
Germany
Outcome results
None listed