Sponsor study identifier
interventional
94
0 countries
N/A
Study Start
June 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2011
Actual (reported)Study Completion
August 2011
Actual (reported)This phase I/II trial will evaluate the bevacizumab/erlotinib combination with the addition of imatinib (Gleevec). The combined inhibition greatly enhances the anti-tumor effects. Although the safety of the bevacizumab/erlotinib/imatinib combination has not yet been demonstrated, the mild to moderate side effects of all of these agents are not predicted to cause prohibitive toxicity. A brief phase I portion will be included in this trial, to optimize doses of the 3 agents prior to proceeding with the phase II trial.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2004
Date type not reportedThis date has not been verified as actual or estimated.
September 12, 2005
Actual (reported)September 19, 2005
Actual (reported)January 2011
Actual (reported)August 2011
Actual (reported)January 14, 2013
Actual (reported)Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
18 months
Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
18 months
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
24 months
In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
10mg/kg IV infusion every 2 weeks
150 mg po daily
Hainsworth JD, Spigel DR, Sosman JA, Burris HA 3rd, Farley C, Cucullu H, Yost K, Hart LL, Sylvester L, Waterhouse DM, Greco FA. Treatment of advanced renal cell carcinoma with the combination bevacizumab/erlotinib/imatinib: a phase I/II trial. Clin Genitourin Cancer. 2007 Dec;5(7):427-32. doi: 10.3816/CGC.2007.n.030.
John D. Hainsworth, MD
SCRI Development Innovations, LLC
94 participants (actual enrollment reported by the registry).
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
June 2004
Date type not reportedThis date has not been verified as actual or estimated.
CCI-779 and Bevacizumab in Treating Patients With Metastatic or Unresectable Kidney Cancer
400-600mg daily
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
January 2011
Actual (reported)Study Completion
August 2011
Actual (reported)Last Updated
January 31, 2013
Results First Posted
January 14, 2013
Record last verified: 2013-01
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Source: ClinicalTrials.gov.
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