EUCTR2012-001337-13-ES
Active, not recruiting
Phase 1
A randomized phase II study to explore the efficacy and feasibility of upfront rotations between sunitinib and everolimus versus sequential treatment of first line sunitinib and second line everolimus until progression in patients with metastatic clear cell renal cancer. - SUNRISES
APRO0 sites115 target enrollmentMay 29, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- APRO
- Enrollment
- 115
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Renal cell carcinoma with a predominant clear cell component confirmed by histology or cytology
- •\-Advanced disease: metastatic AND, not suitable for resection
- •\-Male or female, aged 18 years or older
- •\-ECOG 0 or 1
- •\-Low or intermediate MSKCC prognostic risk score
- •\-Target and/or non\-target lesions according to RECIST 1\.1
- •\-Expected survival of at least 3 months.
- •\-No prior systemic treatment.
- •\-Adequate bone marrow function
- •\-Adequate liver function
Exclusion Criteria
- •\-Prior treatment with VEGF\-targeting agents or multi\-kinase inhibitors or mTOR\-targeting agents
- •\-Active central nervous system metastases.
- •\-Other malignancy diagnosed within the last 5 years, except the following if adequately treated: superficial squamous cell carcinoma or basal cell carcinoma of skin, superficial bladder cancer (T1 and G1 or T1 and G2\), stage 1 cervical cancer.
- •\-Treatment with an investigational agent in the last 4 weeks.
- •\-Known to be HIV positive
- •\-Evidence of chronic hepatitis due to HBV or HCV
- •\-Clinically significant heart disease
- •\-History of hypertension requiring hospitalization.
- •\-Other serious illnesses, e.g. active infection requiring antibiotics, bleeding disorders.
- •\-Immunotherapy or chemotherapy in the last 4 weeks
Outcomes
Primary Outcomes
Not specified
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