Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05941637
Status:
AVAILABLE
Last Update Posted:
2023-07-12
First Post:
2023-07-03
Brief Title:
An Expanded Access Program to Axitinib is Available for Patients With Advanced Forms of Kidney Cancer Ductal Papillary Chromophobic Oncocytic With Mutations in VHL PBRM1 BAP1 SETD2 VEGF
Sponsor:
Lynkcell Europe
Organization:
Lynkcell Europe
Study Overview
Official Title:
An Expanded Access Program to Axitinib is Available for Patients With Advanced Forms of Kidney Cancer Ductal Papillary Chromophobic Oncocytic Confirmed Mutations in VHL PBRM1 BAP1 SETD2 VEGF for Whom Standard Systemic Therapy Has Failed or Progressed in Whom There Are no Satisfactory Treatment Alternatives and Who Are Not Eligible for Other Clinical Trials
Status:
AVAILABLE
Status Verified Date:
2023-07
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:
Kidney cancer belongs to a heterogeneous group of tumors and is the most common oncourological disease up to 80 of cases are clear cell carcinoma
Detailed Description:
The study of rare hereditary forms of clear cell kidney cancer CRP made it possible to identify the VHL gene germline mutations which lead to the development of the Hippel-Lindau syndrome and somatic mutations are characteristic of sporadic CRP The second most frequent mutation independent of VHLmut is the PBRM1 gene involved in chromatin remodeling PBRM1 mutations are positively correlated with SETD2 mutations and negatively correlated with BAP1 mutations Depending on the status of PBRM1BAP1 mutations tumors are characterized by different pathomorphological features and prognoses The main stages of the clonal evolution of SRP which is already at the early stages and is characterized by pronounced intratumoral genetic heterogeneity have been determined However as PRP progresses subclones acquire different secondary mutations that contribute to the activation of the same mTOR and VEGF signaling pathways as well as disrupting the mechanisms of chromatin remodeling and the functioning of TP53 The present program will determine the efficacy of standard doses of axitinib in patients with differentiated mutations in kidney cancer following partial exome sequencing
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