PER-096-08
Completed
未知
A Randomized Phase II Study to Determine the Effect of 2 Different Doses of AVE0005 (VEGF Trap) in Patients With Metastatic Renal Cell Carcinoma
EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),0 sites0 target enrollmentJanuary 13, 2009
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- -C64 Malignant neoplasm of kidney, except renal pelvis
- Sponsor
- EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed metastatic or unresectable renal cell carcinoma; disease must be conventional clear cell carcinoma or have a component of clear cell carcinoma
- •Patient must have measurable lesions according to the Response Evaluation Criteria In Solid Tumors (RECIST); baseline measurements must be performed \=\< 4 weeks prior to randomization
- •Patient must have evidence of progressive disease following treatment with a tyrosine kinase inhibitor (TKI) as assessed by the site investigator on the basis of computed tomography (CT) scans and other appropriate clinical documentation
- •Patient must have received at least one prior treatment with a VEGF receptor tyrosine kinase inhibitor for at least 12 weeks; prior treatment with either temsirolimus or everolimus is allowed; prior immunotherapy is limited to cytokine therapy with interleukin 2 and interferon alpha only
- •Previous radiotherapy (RT) is permissible provided the measurable disease is outside the RT port; RT must be completed \>\= 3 weeks prior to randomization
- •Eastern Cooperative Oncology Group (ECOG) performance status 0\-2
- •Patient must have recovered from any toxic effects of prior radiotherapy or surgical procedures within 4 weeks prior to randomization
- •Adequate organ function as defined in the protocol
- •For women of childbearing potential, a negative serum pregnancy test is required within 1 week prior to randomization
- •Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception while on this study, and for 6 months after the completion of the study; if a woman becomes pregnant while she is on this study or within 6 months after the last dose of protocol therapy, she must inform her treating physician immediately; if a man impregnates a woman while he is on this study or within 6 months after the last dose of protocol therapy, he must inform his treating physician immediately
Exclusion Criteria
- •True papillary, sarcomatoid features without any clear cell component, chromophobe, oncocytoma, collecting duct tumors and transitional cell carcinoma are not eligible
- •Prior immunotherapy other than cytokine therapy with interleukin 2 and interferon alpha
- •Prior treatment with bevacizumab
- •Prior cellular therapy, vaccine, hormonal or chemotherapy for renal cell carcinoma; prior therapy for other cancers is allowable if therapy ended at least 5 years prior to enrollment
- •History of metastatic central nervous system (CNS) disease
- •Pregnant or breastfeeding
- •Myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack within 24 weeks prior to randomization
- •Prior pulmonary embolism, deep vein thrombosis, or other thromboembolic event
- •History of uncontrolled or labile hypertension, with or without antihypertensive drug treatment, within 12 weeks prior to drug administration; this is defined as blood pressure \> 150/100 mm Hg or systolic blood pressure \> 180 mm Hg on at least 2 repeated determinations on separate days
- •Active infection, evidence of bleeding or intratumoral bleeding, or underlying bleeding disorder
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Phase 2
A randomised phase 2 study of carboplatin with oral vinorelbine followed by maintenance therapy with oral vinorelbine or erlotinib in elderly patients with metastatic non-small cell lung cancer.on Small Cell Lung CancerNon Small Cell Lung CancerCancer - Lung - Non small cellACTRN12612000473864Southern Health100
Not yet recruiting
Phase 2
A clinical trial to check the efficacy and safety of MEDI-546 (Study drug) in subjects with Systemic Lupus ErythematosusHealth Condition 1: null- Systemic Lupus ErythematosusCTRI/2012/12/003190MedImmune LLC a member of the AstraZeneca Group of300
Active, not recruiting
Phase 1
AEUCTR2011-004296-36-BGMedImmune, LLC,300
Active, not recruiting
Not Applicable
A Study to evaluate the efficacy and safety of MEDI-546 compared toplacebo in subjects with Systemic Lupus ErythematosusEUCTR2011-004296-36-HUMedImmune, LLC,300
Active, not recruiting
Not Applicable
A study to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with Systemic Lupus ErythematosusSystemic Lupus ErythematosusMedDRA version: 17.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]EUCTR2011-004296-36-CZMedImmune, LLC,300