Everolimus in patients with metastatic renla cell carcinoma previously treated with sunitinib or pazopanib

Phase 1

• Conditions: metastatic renal cell carcinoma; MedDRA version: 16.1Level: LLTClassification code 10038409Term: Renal cell carcinoma NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-003416-23-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-15
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Patients with advanced renal cell carcinoma of a histological or cytological confirmation of clear cell renal carcinoma.
2.Progression during or after a treatment with sunitinib or pazopanib given in a 1st line treatment situation for mRCC.
3.Patients scheduled for treatment with everolimus (Afinitor®).

4.Patients with at least one measurable lesion at baseline as per RECIST-criteria version 1.1.
5.Patients with ECOG PS 0-1.
6.Absolute neutrophile count = 1.5 x 109/L, platelets = 100 x 109/L, Hb > 9 g/dL (5.6 mmol/l).
7.serum bilirubin: = 1.5 x ULN, ALT and AST = 2.5x ULN. Patients with known liver metastases: AST and ALT = 5x ULN.
8.serum creatinine = 2.5 x ULN.
9.Urine protein of < 2+ in dip stick testing.
10.Patients able to give written informed consent.
11.Age =18 years old.

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 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1.Patients who have received >1 prior systemic treatment for their metastatic RCC. Prior systemic treatment in an adjuvant setting is allowed.
2.Patients who have previously received systemic mTOR inhibitors (e.g. sirolimus, temsirolimus, everolimus).
3.Patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients.
4.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 7 days prior to study entry.
5.Patients who have had radiation therapy within 4 weeks prior to start of study treatment. Palliative radiotherapy to bone lesions within 2 weeks prior to study treatment start.
6.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:
oare asymptomatic
and
ohave had no evidence of active CNS metastases for = 3 months prior to enrolment (inactive/controlled CNS metastases are allowed)
and
ohave no requirement for steroids or enzyme-inducing anticonvulsants (e.g. carbamazepine, phenobarbital, phenytoin)
7.Patients in anticipation of the need for major surgical procedure during the course of the study.
8.Patients with a serious non-healing wound, ulcer or bone fracture.
9.Patients with a history of seizure(s) not controlled with standard medical therapy.
10.Patients receiving chronic systemic treatment with corticosteroids (dose of >10 mg/day methylprednisone equivalent) or another immunosuppressive agent. Inhaled and topical steroids are acceptable.
11.Severely impaired lung function with a resting 02-saturation that is 88% or less on room air.
12.Poorly controlled diabetes as defined by fasting serum glucose >2.0 x ULN.
13.Impaired liver function classified as Child-Pugh class A, B, or C.
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.Patients with positive history of severely impaired renal function or prior diagnosis of renal failure or proteinuria.
17.Patients with a known history of HIV seropositivity.
18.Patients with active bleeding.
19.Patients who have any severe and/or uncontrolled medical conditions that could affect their participation in the study, e.g. uncontrolled hypertension defined as systolic blood pressure >160 mmHg and/ or diastolic blood pressure >90 mmHg.
20.Patients who have a history of another primary malignancy and of 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) or prostate (T1 - T2).
21.Female patients who are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml)), or adults of reproductive potential who are not using effective birth control methods (Pearl Index <1). If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Oral contraceptives that do not contain estrogen are acceptable for female patien

Study & Design

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