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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002378-30 | EudraCT Number |
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The study was terminated to be redesigned for a trial according to EMA proposal.
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| Name | Class |
|---|---|
| Mundipharma-EDO GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Small cell lung cancer | Experimental | Histologically- or cytologically-confirmed, limited and extensive SCLC disease with progression after first or second line treatment |
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| 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 |
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| biliary tract cancer | Experimental | Histologically or cytologically confirmed diagnosis of biliary tract cancer progress after first line therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAP7.1 | Drug | CAP7.1 is a prodrug of Etoposide released after via specific carboxyesterase |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to disease progression | Assessment of antitumor activity based on RECIST 1.1 criteria (complete response; partial response; stable disease) | 18 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
| Time to Treatment Failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charite, University Hospital | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28531881 | Derived | Keilholz U, Rohde L, Mehlitz P, Knoedler M, Schmittel A, Kummerlen V, Klinghammer K, Treasure P, Lassus M, Steventon G, Machacek M, Utku N. First-in-man dose escalation and pharmacokinetic study of CAP7.1, a novel prodrug of etoposide, in adults with refractory solid tumours. Eur J Cancer. 2017 Jul;80:14-25. doi: 10.1016/j.ejca.2017.03.032. Epub 2017 May 19. |
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| 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) |
| 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) |
| 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) |