Ignite Creation Date:
2024-05-05 @ 10:49 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01198522
Status:
TERMINATED
Last Update Posted:
2022-04-15
First Post:
2010-09-08
Brief Title:
Combination Therapy of L19IL2 and Gemcitabine in Advanced Pancreatic Cancer Patients
Sponsor:
Philogen SpA
Organization:
Philogen SpA
Study Overview
Official Title:
Phase I Study of the Tumor-targeting Human L19IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer
Status:
TERMINATED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Systemic treatment for advanced non-resectable pancreatic cancer still having minimal impact on the survival of patients Even with the application of more potent gemcitabine-based regimens survival of more than 1 year is uncommon for advanced disease Accordingly there is substantial unmet needs for the improvement of treatment options The combination and simultaneous application of tumor-targeted L19IL2 with gemcitabine could result in improved anti-cancer efficacy based on preliminary clinical and strong preclinical data
The primary purpose of this Phase I study is to define a safe and potentially more active treatment regimen of L19IL2 escalating doses combined with gemcitabine for advanced pancreatic cancer patients Also early signs of anticancer responses of the L19IL2gemcitabine regimen will be assessed and compared to historical controls gemcitabine monotherapy
The primary purpose of this Phase I study is to define a safe and potentially more active treatment regimen of L19IL2 escalating doses combined with gemcitabine for advanced pancreatic cancer patients Also early signs of anticancer responses of the L19IL2gemcitabine regimen will be assessed and compared to historical controls gemcitabine monotherapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007-001609-81 | EUDRACT_NUMBER | None | None |