NCT00098501|CompletedPhase 1
CCI-779 and EKB-569 in Treating Patients With Advanced Solid Tumors
A Phase 1 Trial of CCI-779 in Combination With EKB-569, an EGFR Inhibitor, in Patients With Solid Tumors
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A Phase 1 Trial of CCI-779 in Combination With EKB-569, an EGFR Inhibitor, in Patients With Solid Tumors
Sponsor study identifier
Secondary identifiers
interventional
42
1 country
1
Study Start
October 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2007
Actual (reported)Study Completion
Not reported
Date not reportedThis phase I trial is studying the side effects, best way to give, and best dose of CCI-779 and EKB-569 in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. EKB-569 may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Giving CCI-779 together with EKB-569 may kill more tumor cells.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick 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.
October 2004
Date type not reportedThis date has not been verified as actual or estimated.
December 7, 2004
Actual (reported)December 8, 2004
Actual (reported)October 2007
Actual (reported)Maximum tolerated dose (MTD) defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients
Up to 28 days
Number and severity of all adverse events per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.
Up to 30 days after last dose of study treatment
Best response according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Time from the start of the treatment until disease progression/recurrence, assessed up to 3 years
Time until any treatment related toxicity
Up to 3 years
Time until treatment related grade 3+ toxicity
Up to 3 years
Time until hematologic nadirs (white blood cells [WBC], absolute neutrophil count [ANC], platelets)
Up to 3 years
Time to progression
Up to 3 years
Patients receive oral EKB-569 on days 1-28 and oral CCI-779 on days 1-7 and 15-21.
Given PO
Mayo Clinic
Rochester, Minnesota, 55905, United States
Charles Erlichman
Mayo Clinic
42 participants (actual enrollment reported by the registry).
First Submitted
December 7, 2004
First Posted
December 8, 2004
Study Start
October 2004
Date type not reportedThis date has not been verified as actual or estimated.
Vorinostat and Bortezomib in Treating Patients With Metastatic or Unresectable Solid Tumors
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 2007
Actual (reported)Last Updated
June 4, 2013
Record last verified: 2013-06
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Source: ClinicalTrials.gov.
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