Clear Cell Kidney CancerNCT05941637
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)
A study testing Axitinib 5 MG in people with Clear Cell Kidney Cancer and Kidney Cancer, run by Lynkcell Europe.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Clear Cell Kidney Cancer, Kidney Cancer, Kidney Cancer With PBRM1/BAP1/VHL/SETD2 Mutations
- What is being tested?
- Axitinib 5 MG
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
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.
Read the 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.
- Conditions
- Clear Cell Kidney Cancer, Kidney Cancer, Kidney Cancer With PBRM1/BAP1/VHL/SETD2 Mutations
- Being tested
- Axitinib 5 MG
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axitinib 5 MGDrug
Also called INLYTA, AG-013736
Patients will receive Axitinib (AG 013736) is a multi-target inhibitor of VEGFR1, VEGFR2, VEGFR3, PDGFRβ, and c-Kit - 5mg daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Kidney CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Lynkcell Europe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941637
- Sponsor's protocol ID
- EAR688789-CH
- Status last verified
- Dec 2024
- First submitted
- 3 Jul 2023
- Last updated
- 31 Dec 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05941637
- Acronym / sponsor ID
- EAR688789-CH
- Conditions
- Clear Cell Kidney Cancer, Kidney Cancer, Kidney Cancer With PBRM1/BAP1/VHL/SETD2 Mutations
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Lynkcell EuropeUniversity, hospital or other
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axitinib 5 MGAlso: INLYTA, AG-013736Patients will receive Axitinib (AG 013736) is a multi-target inhibitor of VEGFR1, VEGFR2, VEGFR3, PDGFRβ, and c-Kit - 5mg daily | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Axitinib 5 MG in people with Clear Cell Kidney Cancer and Kidney Cancer, run by Lynkcell Europe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.