Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-01-07 @ 11:06 AM
Study NCT ID:
NCT02094560
Status:
TERMINATED
Last Update Posted:
2018-09-05
First Post:
2014-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CAP7.1 for the Treatment of Advanced Stage, Therapy Refractory Lung and Biliary Tract Tumors
Sponsor:
CellAct Pharma GmbH
Organization:
Study Overview
Official 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)
Status:
TERMINATED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated to be redesigned for a trial according to EMA proposal.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAP7-1
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012-002378-30 | EUDRACT_NUMBER | None | View |