Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304525
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2006-03-17
Brief Title:
A Study to Evaluate RAF265 an Oral Drug Administered to Subjects With Locally Advanced or Metastatic Melanoma
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase III Open-label Dose Escalation Trial to Evaluate the Safety Pharmacokinetics and Pharmacodynamics of RAF265 CHIR-265Administered Orally to Patients With Locally Advanced or Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2020-08
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:
CHIR-265-MEL01
Brief Summary:
The purpose of this study is to determine the safety profile pharmacokinetics pharmacodynamics and maximum tolerated dose of RAF265 in patients with locally advanced and metastatic melanoma
Phase II portion of study dose expansion has been cancelled with Amendment 7 as of Dec 2011
Phase II portion of study dose expansion has been cancelled with Amendment 7 as of Dec 2011
Detailed Description:
The RasRafMEKERK pathway plays a prominent role in controlling several key cellular functions including growth proliferation and survival B-Raf is a member of the RasRafMEKERK pathway and is frequently mutated in melanoma resulting in activation of the MAPK pathway RAF265 is a novel orally active small molecule with potent inhibitory activity against B-Raf kinase and additional antiangiogenic activity through inhibition of vascular endothelial growth factor receptor type 2 VEGFR-2 in non-clinical studies
The primary objectives of this study are to determine the maximum tolerated dose MTD dose limiting toxicities DLTs and the safety profile of RAF265 when administered orally to subjects with locally advanced or metastatic melanoma to determine the plasma pharmacokinetics PKs of orally administered RAF265 and to evaluate potential pharmacodynamic effects of RAF265 using tumor biopsies peripheral blood samples and tumor imaging
The primary objectives of this study are to determine the maximum tolerated dose MTD dose limiting toxicities DLTs and the safety profile of RAF265 when administered orally to subjects with locally advanced or metastatic melanoma to determine the plasma pharmacokinetics PKs of orally administered RAF265 and to evaluate potential pharmacodynamic effects of RAF265 using tumor biopsies peripheral blood samples and tumor imaging
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 |
|---|---|---|---|
| 2007-005367-10 | EUDRACT_NUMBER | None | None |