An open label trial to characterize patients with metastatic renal cell carcinoma treated with everolimus.

Phase 1

• Conditions: metastatic renal cell carcinoma, second line therapy after failure of one VEGF-TKI targeted therapy; MedDRA version: 19.0Level: 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: EUCTR2010-021370-11-DE
• Lead Sponsor: iOMEDICO AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-28
• Last Update Posted: 17 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Each patient must meet the following criteria to be enrolled:
1.Provide written informed consent
2.Aged 18 years and above
3.Histologically or cytologically confirmed predominantly clear cell renal cell carcinoma
4.Metastatic disease documented by CT or MRI (histological confirmation not mandatory but wishful)
5.Patients with or without nephrectomy (partial or total)
6.Patients with at least one measurable lesion at baseline according to RECIST criteria 1.1
7.Failure of exactly one prior VEGFR-TKI therapy (e.g. sunitinib, sorafenib, pazopanib) for metastatic renal cell carcinoma
8.ECOG 0-2
9.Hemoglobin = 9.0 g/dL
10.Platelet count =75,000/µL
11.Absolute neutrophil count =1,5x109/l
12.Serum creatinine < 2.5 x ULN
13.Liver function: Serum bilirubin = 1.5 x ULN, AST or ALT = 2.5 x ULN. For patients with liver metastasis: AST and ALT = 5x ULN
14.Able to swallow the study drug whole as a tablet
15.Expected life expectancy of at least 6 months
16.Women of childbearing potential must have had a negative serum pregnancy test within 14 days prior to the administration of the study treatment or must have a documented condition that prohibits pregnancy (e.g. hysterectomy, post-menopausal).

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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from the study:
1.Patients who have received >1 prior VEGFR-TKI therapy or prior therapy with bevacizumab +/- interferon.
2.VEGFR-TKI therapy within 14 days prior to start of study drug
3.Patients who have previously received systemic mTOR inhibitors (sirolimus, temsirolimus, everolimus).
4.Patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients.
5.Any condition which, in the opinion of the investigator, would preclude participation in this trial
6.Patients within 4 weeks post-major surgery (e.g., intra-thoracic, intra-abdominal or intrapelvic), open biopsy, or significant traumatic injury to avoid wound healing complications. Minor procedures and percutaneous biopsies or placement of vascular access device require 7 days prior to study entry.
7.Patients who had radiation therapy as part of the curative treatment within 4 weeks prior to start of study treatment. Palliative radiotherapy to bone lesions within 2 weeks prior to study treatment start.
8.Patients in anticipation of the need for major surgical procedure during the course of the study.
9.Patients with a serious non-healing wound, ulcer, or bone fracture.
10.Patients with a history of seizure(s) not controlled with standard medical therapy.
11.History or clinical evidence of central nervous system (CNS) metastases. Subjects who have previously-treated CNS metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) and meet all 3 of the following criteria are eligible:
a) are asymptomatic and,
b) have had no evidence of active CNS metastases for = 3 months prior to enrolment (inactive/controlled CNS metastases are allowed) and,
c) have no requirement for steroids or enzyme-inducing anticonvulsants (e.g. carbamazepine, phenobarbital, phenytoin)
12.Patients receiving chronic systemic treatment with corticosteroids (dose of > 10 mg/day methylprednisone equivalent) or another immunosuppressive agent. Inhaled and topical steroids are acceptable.
13.Poorly controlled diabetes as defined by fasting serum glucose >2.0 x ULN.
14.Active (acute or chronic) or uncontrolled infection of bacterial, mycotic or viral genesis.
15.Liver disease such as chronic active hepatitis or chronic persistent hepatitis.
16.Impaired liver function classified as Child-Pugh class C.
17.Patients with a known history of HIV seropositivity.
18.Patients with active bleeding disorders.
19.Patients who have any severe and/or uncontrolled medical conditions or other conditions within the past 12 months that could affect their participation in the study or any disorders that impair the ability to evaluate the patient or for the patient to complete the study according to the investigators assessment.
20.Patients who have a history of another primary malignancy and off treatment for = 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix or breast, and localized cancer of the bladder (T1) and prostate (T1 - T2).
21.Female patients who are pregnant or breast feeding.
22. Men and women of reproductive potential who are not using highly effective birth control methods. Oral contraceptives for female patients and barrier contraceptives are not acceptable. For definition of highly effective birth control methods please refer to section 12.3.6 of this protocol.
23.Patients who are using other investigational agents or w

Study & Design

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