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)
Primary Purpose
Clear Cell Kidney Cancer, Kidney Cancer, Kidney Cancer With PBRM1/BAP1/VHL/SETD2 Mutations
Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Axitinib 5 MG
Sponsored by
About this trial
This is an expanded access trial for Clear Cell Kidney Cancer
Eligibility Criteria
Inclusion Criteria: Histologically documented metastatic renal cell cancer or cell kidney cancer Evidence of measurable disease. Adequate renal function (serum creatinine level) ECOG Status 0-1 Patient must provide signed informed consent Male or female, age >/= 18 years Exclusion Criteria: Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors Current use or anticipated need for treatment with drugs that are known as potent CYP3A4 or CYP1A2. Active gastrointestinal bleeding. Severe allergic reactions Unwillingness or inability to comply with mandated pretreatment biopsy or therapeutic regimen
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05941637
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)
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.
Study Type
Expanded Access
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lynkcell Europe
4. Oversight
5. Study Description
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 PBRM1/BAP1 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clear Cell Kidney Cancer, Kidney Cancer, Kidney Cancer With PBRM1/BAP1/VHL/SETD2 Mutations
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Axitinib 5 MG
Other Intervention Name(s)
INLYTA, AG-013736
Intervention Description
Patients will receive Axitinib (AG 013736) is a multi-target inhibitor of VEGFR1, VEGFR2, VEGFR3, PDGFRβ, and c-Kit - 5mg daily
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Eligibility Criteria
Inclusion Criteria:
Histologically documented metastatic renal cell cancer or cell kidney cancer
Evidence of measurable disease.
Adequate renal function (serum creatinine level)
ECOG Status 0-1
Patient must provide signed informed consent
Male or female, age >/= 18 years
Exclusion Criteria:
Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors
Current use or anticipated need for treatment with drugs that are known as potent CYP3A4 or CYP1A2.
Active gastrointestinal bleeding.
Severe allergic reactions
Unwillingness or inability to comply with mandated pretreatment biopsy or therapeutic regimen
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trials Team
Phone
31639419750
Email
pharma@mail.co.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Trials Team
Phone
0766181519
Email
pharma@mail.co.uk
12. IPD Sharing Statement
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8548775/
Description
Related Info
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7097956/
Description
Related Info
URL
https://pubmed.ncbi.nlm.nih.gov/22949125/
Description
Related Info
Learn more about this trial
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)
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