Trial Outcomes & Findings for Brivanib Metastatic Renal Cell Carcinoma (NCT NCT01253668)
NCT ID: NCT01253668
Last Updated: 2021-04-13
Results Overview
All patients will be followed through the entire 16-week period and will be given a binary outcome assignment: progressive disease or not.
TERMINATED
PHASE2
10 participants
16 weeks
2021-04-13
Participant Flow
Participant milestones
| Measure |
Arm 1
Patients receive oral brivanib alaninate daily in the absence of disease progression or unacceptable toxicity.
Brivanib alaninate: Brivanib by mouth daily at a dose of 800mg.
Polymerase chain reaction: Undergo 1241-cG250 PET/CT imaging (correlative studies)
Iodine I 124 chimeric monoclonal antibody G250: Undergo 124I-cG250 PET/CT imaging (correlative studies)
Positron emission tomography/computed tomography: Undergo 1241-cG250 PET/CT imaging (correlative studies)
Protein expression analysis: Correlative studies
Immunohistochemistry: correlative studies
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|---|---|
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Overall Study
STARTED
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0
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brivanib Metastatic Renal Cell Carcinoma
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 16 weeksPopulation: The study was terminated, and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported.
All patients will be followed through the entire 16-week period and will be given a binary outcome assignment: progressive disease or not.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 8 weeksPopulation: The study was terminated, and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported.
The best overall radiographic response to therapy as measured and assessed using RECIST 1.1 guidelines will be captured for each research subject.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 8 weeksPopulation: The study was terminated, and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and 8 weeksPopulation: The study was terminated, and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 8 weeksPopulation: The study was terminated, and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported.
Response Rate for all patients as assessed by RECIST 1.1 guidelines
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baselinePopulation: The study was terminated, and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported.
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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and week 3Population: The study was terminated, and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported.
Changes in collagen IV levels for each patient (correlative studies)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and week 3Population: The study was terminated, and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported.
Germline polymorphisms and assessment of relationship to toxicity and clinical outcome (correlative studies)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, day 1 weeks 3,6,8,12,16 and every 6-8 weeks thereafterPopulation: The study was terminated, and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported.
Blood pressure data
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1, weeks 3,6,9,12,16, and every 6-8 weeks thereafterPopulation: The study was terminated, and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data are available to be reported.
Toxicity as assessed by NCI CTCAE version 4.0
Outcome measures
Outcome data not reported
Adverse Events
Arm 1
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place