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)

NCT05941637 | Unknown

• 1 other identifier: EAR688789-CH
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Clear Cell Kidney Cancer; Kidney Cancer; Kidney Cancer With PBRM1/BAP1/VHL/SETD2 Mutations

Interventions

Axitinib 5 MG DRUG

Patients will receive Axitinib (AG 013736) is a multi-target inhibitor of VEGFR1, VEGFR2, VEGFR3, PDGFRβ, and c-Kit - 5mg daily

Also known as: INLYTA, AG-013736

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lynkcell Europe: lead

Related Links

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MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Axitinib

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 12, 2023
• Last Updated: December 31, 2024

Record last verified: 2024-12