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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
Lynkcell Europe
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Clear Cell Kidney Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All Sexes

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

    First Posted
    July 3, 2023
    Last Updated
    July 3, 2023
    Sponsor
    Lynkcell Europe
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    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
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    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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