Clinical trial for the evaluation of a new drug (cabozantinib) treatment given before having kidney surgery in patients with kidney cancer that is advanced or has spread

Phase 1

• Conditions: ocally Advanced or Metastatic Renal Cell Carcinoma; MedDRA version: 20.0Level: PTClassification code 10050513Term: Metastatic renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-001201-93-ES
• Lead Sponsor: Fundación ONCOSUR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-02
• Last Update Posted: 1 October 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients must meet the following inclusion criteria:

1. Patients with locally advanced or metastatic renal cell carcinoma with a clear cell component confirmed histologically by biopsy.

2. Patients eligible for CN according to their surgical risk established in routine clinical practice at the center.

3. Age = 18 years.

4. Patients with an ECOG performance status of between 0 and 1.

5. Patients with appropriate organ and bone marrow function within 4 weeks prior to starting treatment with cabozantinib:
oLeukocyte count > 4,000 cells/µL
oHemoglobin > 9 g/dL
oPlatelet count > 100,000/mm3
oSerum creatinine < 2.0 mg/dL or serum creatinine clearance > 30 mL/min (according to the Cockcroft-Gault formula (Cockcroft and Gault 1976).
oPreserved 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.
oLipase < 2 x ULN. Amilase < 2 x LSN
oINR and APTT = 1.5 x ULN of the center. This only applies to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation with low molecular weight heparins should maintain stable doses.

6. Patients with no radiological or clinical evidence of pancreatitis.

7. Patients with evaluable tumor disease according to the RECIST criteria 1.1 (Eisenhauer et al. 2009).

8. Patients with controlled blood pressure (systolic < 145 mmHg; diastolic blood pressure < 90 mmHg).

9. Patients who sign informed consent to participate in the study.

10. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Patients with a second active malignant tumor.

2. Patients with tumors treated in the last 2 years.

3. Pregnant or breast-feeding women.

4. 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 criteria) during the treatment period. Both 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 can not possibly be considered effective contraceptive methods, they should be used in conjunction with another method, such as a barrier method.

5. 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 criteria) during the treatment period.

6. Patients with gastrointestinal disorders, including:
oInability to take oral medication.
oNeed for parenteral nutrition.
oPrior surgical procedures affecting absorption.
oActive gastrointestinal bleeding.
oMalabsorption syndrome.
oGastrointestinal disorders that increase the risk of perforation.

7. 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.

8. Patients with tumors that invade or affect major blood vessels, gastrointestinal tract, or trachea/bronchi.

9. Patients with human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related diseases.

10. Patients with active hepatitis or hepatitis C.

11. Patients with active tuberculosis.

12. Patients with uncontrolled (Ca > 12 mg/dL) or symptomatic hypercalcemia who require continuous treatment with bisphosphonates or denosumab.

13. Patients who have undergone major surgery within 4 weeks prior to inclusion in the study.

14. Patients with active bleeding.

15. Patients with a recent episode of intestinal obstruction.

16. Patients who have previously received VEGF growth factor-targeted therapy for advanced disease.

17. 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.

18. Patients who have received an allogeneic transplant or stem cells in the last 5 years.

19. 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.

20. 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.

21. 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)

22. Any other clinical condition that the physician responsible for the patient con

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified