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Renal Cell Carcinoma MetastaticPhase 2NCT06377722

Cabozantinib Treatment Prior to Cytoreductive Nephrectomy in Patients With Advanced or Metastatic Renal Cells Cancer

A Phase 2 study testing Cabozantinib in people with Renal Cell Carcinoma Metastatic and Renal Cell Carcinoma Stage IV, run by Fundacion Oncosur at 8 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Phase II, multicenter, national, uncontrolled, multicenter, uncontrolled, phase II clinical trial for the evaluation of cabozantinib treatment prior to cytoreductive nephrectomy in patients with advanced or metastatic renal cell cancer candidates for primary tumor cytoreductive nephrectomy (NC). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cabozantinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
8 sitesSpain
Study dates
1 Nov 2018to 9 Aug 2022
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with locally advanced or metastatic renal cell carcinoma with a clear cell component confirmed histologically by biopsy.
  • Patients eligible for cytoreductive nephrectomy according to their surgical risk established in routine clinical practice at the site.
  • Age ≥ 18 years.
  • Patients with an ECOG (Eastern Cooperative Oncology Group) performance status of between 0 and 1.
  • Patients with appropriate organ and bone marrow function within 4 weeks prior to starting treatment with cabozantinib:
  • Leukocyte count > 4,000 cells/μL
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  • Hemoglobin > 9 g/dL
  • Platelet count > 100,000/mm3
  • Serum creatinine < 2.0 mg/dL or serum creatinine clearance > 30 mL/min (according to the Cockcroft-Gault formula (Cockcroft and Gault 1976).
  • Preserved liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN) in the absence of liver metastases; < 5 x ULN in the case of liver metastases.
  • Lipase < 2 x ULN. Amylase < 2 x ULN.
  • INR (international normalized ratio) and APTT (activated partial thromboplastin time) ≤ 1.5 x ULN of the site. This only applies to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation with low molecular weight heparins should maintain stable doses.
  • Patients with no radiological or clinical evidence of pancreatitis.
  • Patients with evaluable tumor disease according to the RECIST criteria 1.1 (Eisenhauer et al. 2009).
  • Patients with controlled blood pressure (systolic < 145 mmHg; diastolic blood pressure < 90 mmHg).
  • Patients who sign informed consent to participate in the study.
  • Patients may have brain metastases appropriately treated with radiation therapy and/or surgery (including radiosurgery), as long as they do not require the concomitant use of corticosteroids.

Who cannot join

  • Patients with a second active malignant tumor.
  • Patients with tumors treated in the last 2 years.
  • Pregnant or breastfeeding women.
  • Women of child-bearing potential who do not agree to use a contraceptive method during treatment. Women participating in the study should have undergone surgical sterilization, be post-menopausal, or agree to use a highly effective contraceptive method (in accordance with CTFG (clinical trial facilitation group) criteria) during the treatment period. Patients of both sexes and their partners must use effective contraception during treatment and, at least, up to four months after completing treatment. Since oral contraceptives cannot possibly be considered "effective contraceptive methods", they should be used in conjunction with another method, such as a barrier method
  • Fertile men who do not agree to use a contraceptive method during treatment. Male participants in the study should have undergone surgical sterilization, or agree to use a highly effective contraceptive method (in accordance with CTFG (clinical trial facilitation group) criteria) during the treatment period.
  • Patients with gastrointestinal disorders, including:
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  • Inability to take oral medication.
  • Need for parenteral nutrition.
  • Prior surgical procedures affecting absorption.
  • Active gastrointestinal bleeding.
  • Malabsorption syndrome.
  • Gastrointestinal disorders that increase the risk of perforation.
  • Patients who have had any of the following conditions within the 12 months prior to inclusion in the study: myocardial infarction, uncontrolled angina, uncontrolled hypertension, peripheral arterial or coronary graft bypass, congestive heart failure, stroke, or transient ischemic attack.
  • Patients with tumors that invade or affect major blood vessels, gastrointestinal tract, or trachea/bronchi.
  • Patients with human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related diseases.
  • Patients with active hepatitis or hepatitis C.
  • Patients with active tuberculosis.
  • Patients with uncontrolled (Ca > 12 mg/dL) or symptomatic hypercalcemia who require continuous treatment with bisphosphonates or denosumab.
  • Patients who have undergone major surgery within 4 weeks prior to inclusion in the study.
  • Patients with active bleeding.
  • Patients with a recent episode of intestinal obstruction.
  • Patients who have previously received VEGF (vascular endothelial growth factor)-targeted therapy for advanced disease.
  • Patients who have undergone radiation therapy for bone metastases within 2 weeks prior to the first dose of cabozantinib, or any external radiation therapy within 4 weeks prior to the first dose of cabozantinib.
  • Patients who have received an allogeneic transplant or stem cells in the last 5 years.
  • Malignant tumors within 3 years before Day 1 of Cycle 1, except for those with negligible risk of metastasis or death and who have been treated with curative intent, such as cervical carcinoma in situ or localized prostate cancer treated with curative intent.
  • Patients receiving therapeutic doses of oral anticoagulants (e.g., warfarin, direct thrombin inhibitors and Factor Xa) or antiplatelet agents (e.g., clopidogrel). The use of low molecular weight heparins is allowed
  • Hypersensitivity to the active substance or to any of the excipients (exclude lactose intolerant patients since each film-coated tablet contains 46.61 mg of lactose).
  • Any other clinical condition that the physician responsible for the patient considers to be inappropriate for inclusion in the study.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Spain8 sites

  • Institut Català d'Oncologia. Idibell

    L'Hospitalet de Llobregat, Barcelona

  • Hospital Univeristario 12 de Octubre

    Madrid, 28041

  • Centro Oncológico Clara Campal - HM CIOCC

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Ramón y Cajal

    Madrid

  • Hospital Universitario Severo Ochoa

    Madrid

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias

  • Hospital Universitario de Valdecilla

    Santander, Cantabria

Other trials in Spain

About this study

Official title: Phase II Study for the Evaluation of Neoadjuvant Treatment With Cabozantinib Pior to Cytoreductive Nephrectomy in Patients With Advanced or Metastatic Renal Cells Cancer

Phase II, multicenter, national, uncontrolled, multicenter, uncontrolled, phase II clinical trial for the evaluation of cabozantinib treatment prior to cytoreductive nephrectomy in patients with advanced or metastatic renal cell cancer candidates for primary tumor cytoreductive nephrectomy (NC).

Read the detailed description

Metastatic Renal cell carcinoma (RCC) is a type of kidney cancer that arises in the small tubes of the kidneys and has spread to other parts of the body (advanced cancer/metastases). Patients typically have surgery to remove a part or all of their kidney (called partial or radical nephrectomy). Other treatments include chemotherapy, targeted therapy, immunotherapy and hormone therapy and may be used before or after surgery or radiotherapy.

There is no standard drug therapy given before surgery, but such preoperative therapy is used widely in the treatment of other cancer types. This approach has several potential advantages, including shrinking the tumor to help improve surgical outcomes and to help find an appropriate drug therapy.

Cabozantinib is the generic for the trade chemotherapy drug CABOMETYX™ (cabozantinib). It is known as a cancer growth inhibitor and also an angiogenesis inhibitor. Tyrosine kinases are proteins that control how cells grow and divide. By blocking the activity of these proteins in cancer cells, the medicine reduces the growth and spread of cancer.

This study tries to clarify whether Cabozantinib could be a safe and effective preoperative treatment in patients with advanced RCC who were candidates for removing a part or all of their kidney.

Being tested
Cabozantinib
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CabozantinibDrug

    Also called No other intervention names

    This study tries to clarify whether Cabozantinib could be a safe and effective preoperative treatment in patients with advanced RCC who were candidates for removing a part or all of their kidney.

Study groups in NCT06377722
Study groupRoleWhat they receive
Treatment with cabozantinib prior to cytoreductive nephrectomyExperimentalTo evaluate the efficacy of preoperative cabozantinib treatment as measured by the radiological response rate prior to NC in patients with advanced or metastatic renal cell cancer candidates for NC.
Receives: Drug: Cabozantinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiological response rate prior to cytoreductive nephrectomy

    Objective response to preoperative treatment with cabozantinib, defined as the percentage of patients that reach complete or partial radiological response after a 12-week cycle of treatment with cabozantinib, defined according to the RECIST 1.1 criteria (Response Evaluation Criteria In Solid Tumors: complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD))

    Measured: At 12 weeks following the start of the treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2024
  2. Study start1 Nov 2018
  3. Primary completion9 Aug 2022
  4. Study completion9 Aug 2022

Why it stopped: The achieved number of samples has been smaller than the planned 50 thus, a mainly descriptive final result analysis was conducted, as presented herein.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06377722
Sponsor's protocol ID
CABOPRE
Status last verified
Apr 2024
First submitted
17 Apr 2024
Last updated
26 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cabozantinib in people with Renal Cell Carcinoma Metastatic and Renal Cell Carcinoma Stage IV, run by Fundacion Oncosur at 8 sites in Spain.

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 17 inclusion and 28 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: stopped early, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The achieved number of samples has been smaller than the planned 50 thus, a mainly descriptive final result analysis was conducted, as presented herein.). 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.

What does the primary outcome measure?

Radiological response rate prior to cytoreductive nephrectomy (time frame: At 12 weeks following the start of the treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06377722.

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 26 Apr 2024.

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