Brivanib Metastatic Renal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT01253668|
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : December 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Male and Female Subjects 18 Years of Age and Older With Metastatic Renal Cell Carcinoma. Eligible Patients Must Have Undergone and Failed Prior Treatment.||Drug: Brivanib alaninate Genetic: Polymerase chain reaction Other: Iodine I 124 chimeric monoclonal antibody G250 Procedure: Positron emission tomography/computed tomography Genetic: Protein expression analysis Other: Immunohistochemistry||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Brivanib (BMS-582664, Brivanib Alaninate) in Treatment of Refractory Metastatic Renal Cell Carcinoma - A Phase II Pharmacodynamic and Baseline Biomarker Study|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
Experimental: Arm 1
Patients receive oral brivanib alaninate daily in the absence of disease progression or unacceptable toxicity.
Drug: Brivanib alaninate
Brivanib by mouth daily at a dose of 800mg.Genetic: Polymerase chain reaction
Undergo 1241-cG250 PET/CT imaging (correlative studies)
Other Name: PCROther: Iodine I 124 chimeric monoclonal antibody G250
Undergo 124I-cG250 PET/CT imaging (correlative studies)Procedure: Positron emission tomography/computed tomography
Undergo 1241-cG250 PET/CT imaging (correlative studies)Genetic: Protein expression analysis
Correlative studiesOther: Immunohistochemistry
Other Name: immunohistochemistry staining method
- Progression Free Survival (PFS) [ Time Frame: 16 weeks ]All patients will be followed through the entire 16-week period and will be given a binary outcome assignment: progressive disease or not.
- Best overall response rate dfor each patients as assessed by RECIST 1.1 guidelines [ Time Frame: Every 8 weeks ]The best overall radiographic response to therapy as measured and assessed using RECIST 1.1 guidelines will be captured for each research subject.
- Overall survival [ Time Frame: Every 8 weeks ]Will record deaths on study, and, to the extent possible, after the study follow-up period is completed for each patient, will be captured. Reason for death will be identified and recorded where possible.
- Change in total antibody binding as assessed by 124I-cG250 PET/CT imaging (correlative studies) [ Time Frame: At baseline and 8 weeks ]Will determine the baseline and change in total antibody binding in lesions from baseline to the time on treatment that patients are assessed. The analysis dataset will be quantitated radiotracer uptake data obtained via I-cG250 PET/CT for all evaluable patients who complete the trial.
- Response rate for all patients [ Time Frame: Every 8 weeks ]Response Rate for all patients as assessed by RECIST 1.1 guidelines
- Molecular markers [ Time Frame: At baseline ]Molecular markers expressed in patient tumor specimens as assessed by IHC and histocytometry (e.g., VHL, HIF, p-STAT3, p-ERK, and Ki67, VEGFR2, and FGFR1) (correlative studies)
- Changes in collagen IV levels [ Time Frame: At baseline and week 3 ]Changes in collagen IV levels for each patient (correlative studies)
- Germline polymorphisms and assessment of relationship to toxicty and clinical outcome [ Time Frame: At baseline and week 3 ]Germline polymorphisms and assessment of relationship to toxicity and clinical outcome (crrelative studies)
- Blood pressure data [ Time Frame: At baseline, day 1 weeks 3,6,8,12,16 and every 6-8 weeks thereafter ]Blood pressure data
- Toxicity as assessed by NCI CTCAE version 4.0 [ Time Frame: Day 1, weeks 3,6,9,12,16, and every 6-8 weeks thereafter ]Toxicity as assessed by NCI CTCAE version 4.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01253668
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Stephen Keefe, MD||Abramson Cancer Center of the University of Pennsylvania|