Sym004 in Patients With Advanced Solid Tumors
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, Multi-center Phase I Dose Escalation Study to Investigate the Safety and Tolerability of Multiple Doses of Sym004 in Patients With Advanced Solid Tumors|
- Adverse events [ Time Frame: 4 weeks ]DLTs (DLT period of 4 weeks after first dose in each patient) along with; incidence and severity of Adverse Events (AEs), including Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) during the entire trial period.
- Objective tumor response according to RECIST criteria verified by imaging techniques [ Time Frame: 01/02/2010 to 31/07/2014 ]
- Duration of overall response [ Time Frame: 01/02/2010 to 31/07/2014 ]
- Progression free survival [ Time Frame: 01/02/2010 to 31/07/2014 ]
- Overall survival [ Time Frame: 01/02/2010 to 31/07/2014 ]
- Host immune response: ADA monitoring [ Time Frame: 01/02/2010 to 31/07/2014 ]
- Skin rash according to CTCAE grading [ Time Frame: 01/02/2010 to 31/07/2014 ]
- Biomarker including CEA and YKL 40 [ Time Frame: 01/02/2010 to 31/07/2014 ]
- Vital signs and laboratory parameters [ Time Frame: 01/02/2010 to 31/07/2014 ]
- Pharmakokinetic profile of multiple weekly and biweekly doses of Sym004 [ Time Frame: 24/08/2010 to 31/07/2014 ]
|Study Start Date:||March 2010|
|Study Completion Date:||May 2015|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
In part A, patients in all dose cohorts will continue weekly treatment with the assigned dose of Sym004 until disease progression.
In Part B, patients will continue weekly treatment with the tolerated dose of Sym004 until disease progression.
In Part C, patients will receive weekly doses of Sym004 at the dose level below 12 mg/kg i.e. 9 mg/kg until disease progression.
In Part D and E, patients will receive doses of Sym004 administered every 2 weeks at dose level 12 mg/kg and 18 mg/kg, respectively until disease progression.
In Part F, patients will receive a single loading dose of 9 mg/kg followed by weekly doses of 6 mg/kg.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01117428
|United States, Texas|
|South Texas Accelerated Research Therapeutics (START)|
|San Antonio, Texas, United States, 78229|
|UZ Brussel, Medische Oncologie|
|Brussel, Belgium, 1090|
|UZ Gasthuisberg, Digestive Oncology Unit|
|Brussel, Belgium, 3000|
|UZ Antwerp, Oncologie|
|Edegem, Belgium, 2650|
|Medical Oncology Department, Vall d´Hebron University Hospital|
|Barcelona, Spain, 08035|
|Servicio de Oncología Médica, Hospital Universitario Virgen del Rocío|
|Sevilla, Spain, 41013|
|Hospital Clínico Universitario de Valencia|
|Valencia, Spain, 46010|
|Principal Investigator:||Josep Tabernero, Dr.||Hospital Vall d'Hebron BCN ES|