NL-OMON43872
Completed
Phase 2
Phase 1-2 study of everolimus and low-dose oral cyclophosphamide in patients with metastatic renal cell cancer. - Everolimus-LDcyclo
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Kidney cancer
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 96
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with histologically or cytologically confirmed clear\-cell mRCC with progressive disease and not amenable to or progressive on or within 6 months of stopping treatment with a VEGF receptor tyrosine kinase inhibitor (sunitinib (or pazopanib) ± sorafenib).
- •2\. Prior therapy with cytokines (i.e. IL\-2, interferon) and/or VEGF\-ligand inhibitors (i.e. bevacizumab) is permitted.
- •3\. Patients with brain metastases are eligible if they have been stable for at least two months post\-radiation therapy or surgery.
- •4\. Aged 18 years or older.
- •5\. No other current malignant disease, except for basal cell carcinoma of the skin.
- •6\. WHO performance status 0\-2\.
- •7\. Life expectancy of at least 12 weeks.
- •8\. Adequate hematologic function: ANC \>\= 1\.5 x 109/L, platelets \>\= 100 x 109/L, Hb \>\= 6\.0 mmol/L.
- •9\. Adequate hepatic function: serum bilirubin \<\= 1\.5 x ULN, ALT and AST \<\= 2\.5 x ULN (or \<\= 5 times ULN if liver metastases are present).
- •10\. Adequate renal function: calculated creatinine clearance \>\= 50 ml/min.
Exclusion Criteria
- •1\. Patients currently receiving chemotherapy, immunotherapy, or radiotherapy or who have received these \<\= 4 weeks prior to visit 1\. Radiotherapy on a non\-target lesion is allowed \>\= 2 weeks prior to visit 1\.The wash\-out period for sunitinib or sorafenib is at least 2 weeks from the first dose of the study medication.
- •2\. Known human immunodeficiency virus (HIV) or other major immunodeficiency.
- •3\. Immunosuppressive agents within 3 weeks of study entry, except for low dose corticosteroids with a maximum daily dose of 10mg prednisone or equivalent. Topical or inhaled corticosteroids are permitted.
- •4\. Patients with an active bleeding diathesis or on oral anti\-vitamin K medication.
- •5\. Patients with untreated CNS metastases with clinical symptoms or who have received treatment for CNS metastases within 2 months of study entry. Patients with treated CNS metastases, who are neurologically stable and off of corticosteroids for more than 2 months prior to study entry are eligible to enter the study.
- •6\. Active infection or serious intercurrent illness, except asymptomatic bacteriuria.
- •7\. Presence of unstable angina, recent myocardial infarction (within the previous 6 months), or use of ongoing maintenance therapy for life\-threatening ventricular arrhythmia.
- •8\. Macroscopic hematuria
- •9\. Prior therapy with mTOR inhibitors.
- •10\. Known hypersensitivity to everolimus or other rapamycins (sirolimus/temsirolimus) or to its excipients.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Phase 1-2 study of everolimus and low-dose oral cyclophosphamide in patients with metastatic renal cell cancer.Metastatic renal cell cancerMedDRA version: 12.1Level: LLTClassification code 10050513Term: Metastatic renal cell carcinomaEUCTR2010-024515-13-NLVU University Medical Center
Recruiting
Not Applicable
Een fase 1-2 studie van everolimus en lage dosis orale cyclofosfamide bij patiënten met uitgezaaide niercelkanker.Metastatic renal cell cancer.NL-OMON21801VU University Medical Center96
Completed
Phase 2
Study of preoperative everolimus in metastatic renal cell cancerISRCTN22979604Royal Marsden NHS Foundation Trust (UK)40
Active, not recruiting
Not Applicable
Everolimus and Fulvestrant therapy in postmenopausal metastatic Breast Cancer at patient treated with fulvestrant and who progressed on or after mTor inhibitor based treatmentpostmenopausal women with hormone receptor-positive, Her2 negative AI and fulvestrant treated, locally advanced or metastatic breast cancer, who progressed on prior fulvestrant and also received prior treatment with everolimus and exemestane. The treatment with fulvestrant is not required to be the last treatment administered as long as at some point in time a progression on fulvestrant has been ascertained.MedDRA version: 14.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2013-000665-36-BEZ Brussel
Completed
Phase 2
A phase 2 trial of EVERolimus alternating with SUNitinib as first line therapy for advanced renal cell carcinomaACTRN12609000643279The University of Sydney55