Advanced Endstage Solid Carcinomas in Adults Clinical Trial
— CAP7-1Official title:
Phase II Trial of CAP7.1 in Adult Patients With Refractory Malignancies: Small Cell Lung Carcinoma, Non-Small Cell Lung Carcinoma, Biliary Carcinoma (PIITCAP)
| Verified date | August 2018 |
| Source | CellAct Pharma GmbH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 45 |
| Est. completion date | April 10, 2017 |
| Est. primary completion date | September 8, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Charite, University Hospital | Berlin |
| Lead Sponsor | Collaborator |
|---|---|
| CellAct Pharma GmbH | Mundipharma-EDO GmbH |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to disease progression | Assessment of antitumor activity based on RECIST 1.1 criteria (complete response; partial response; stable disease) | 18 month | |
| Secondary | 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) | ||
| Secondary | Time to Treatment Failure | Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months) | ||
| Secondary | Progression-Free Survival (PFS) | Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months) | ||
| Secondary | Disease-free survival | Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months) | ||
| Secondary | Overall Survival (OS) | Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months) | ||
| Secondary | 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) | ||
| Secondary | 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) | ||
| Secondary | 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) | ||
| Secondary | 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) | ||
| Secondary | 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) |