Ignite Creation Date:
2024-05-05 @ 10:33 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01131364
Status:
TERMINATED
Last Update Posted:
2014-02-25
First Post:
2010-05-25
Brief Title:
Combination Therapy of F16IL2 and Doxorubicin in Solid Tumour Patients
Sponsor:
Philogen SpA
Organization:
Philogen SpA
Study Overview
Official Title:
A Dose-finding Pharmacokinetic Phase IbII Study of the Tumour-targeting Human F16IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Doxorubicin in Patients With Advanced Solid Tumours
Status:
TERMINATED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase IbII study is an openlabel multicenter study for patients with solid tumors and breast cancer amenable to anthracyclin therapy
The study is divided in two parts
Phase I an open-label dose escalation study of F16IL2 in combination with doxorubicin for patients with solid tumors
Phase II a prospective single-arm multicentre study of a fixed dose of F16IL2 in combination with doxorubicin equivalent to stage 1 of the Simon two-stage phase II design for patients with breast cancer amenable to anthracyclin therapy
The study is divided in two parts
Phase I an open-label dose escalation study of F16IL2 in combination with doxorubicin for patients with solid tumors
Phase II a prospective single-arm multicentre study of a fixed dose of F16IL2 in combination with doxorubicin equivalent to stage 1 of the Simon two-stage phase II design for patients with breast cancer amenable to anthracyclin therapy
Detailed Description:
Breast cancer is a major cause of cancer mortality second only to lung cancer as a cause of cancer death in women The five-year survival rate for localized breast cancer has increased from 80 percent in the 1950s to 98 percent today However the mortality rate in the most advanced forms remains unsatisfactory Indeed the extensive use of mammography within screening programs has led to cancers being detected earlier when early treatments may be more effective A greater understanding of the molecular biology and genetic expression of breast cancer has therefore led to new pre-surgical and post-surgical treatments including hormone modulators and monoclonal antibodies Many of these agents have led to decreased mortality and disease recurrence
F16 is a human recombinant antibody fragment in the scFv single chain Fragment variable format that is directed against tenascin C an angiogenesis marker common to most solid tumors independent of the tumor type ScFvF16 selectively localizes in tumor tissues in animal models as demonstrated both histologically and during mechanistic studies involving mice transfected with orthotopic human tumours
IL2 the human cytokine interleukin-2 is a potent stimulator of the immune response It has a central role in the regulation of T cell responses and effects on other immune cells such as natural killer cells B cells monocytemacrophages and neutrophils Smith 1988 IL2 can induce tumor regression through its ability to stimulate a potent cell-mediated immune response in vivo Rosenberg 2000
F16 is a human recombinant antibody fragment in the scFv single chain Fragment variable format that is directed against tenascin C an angiogenesis marker common to most solid tumors independent of the tumor type ScFvF16 selectively localizes in tumor tissues in animal models as demonstrated both histologically and during mechanistic studies involving mice transfected with orthotopic human tumours
IL2 the human cytokine interleukin-2 is a potent stimulator of the immune response It has a central role in the regulation of T cell responses and effects on other immune cells such as natural killer cells B cells monocytemacrophages and neutrophils Smith 1988 IL2 can induce tumor regression through its ability to stimulate a potent cell-mediated immune response in vivo Rosenberg 2000
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 |
|---|---|---|---|
| 2007-006176-11 | EUDRACT_NUMBER | None | None |