BI 2536 in Treating Patients With Recurrent or Metastatic Solid Tumors
RATIONALE: BI 2536 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects and how well BI 2536 works in treating patients with recurrent or metastatic solid tumors.
Head and Neck Cancer
Drug: BI 2536
Other: high performance liquid chromatography
Other: mass spectrometry
Other: pharmacological study
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter Parallel Phase II Trial of BI 2536 Administered as One Hour IV Infusion Every 3 Weeks in Defined Cohorts of Patients With Various Solid Tumors. A New Drug Screening Program of the EORTC Network of Core Institutions (NOCI)|
- Confirmed objective response rate (complete and partial responses) as defined by RECIST [ Designated as safety issue: No ]
- Clinical benefit as assessed by RECIST [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Overall progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Safety as assessed by CTCAE version 3.0 [ Designated as safety issue: Yes ]
|Study Start Date:||July 2007|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
- Investigate if BI 2536 demonstrates antitumor activity in the selected tumor types.
- Further document its safety profile in the treated patient population.
- Describe the plasma concentration time-course following administration of a single administration of BI 2536 in patients with different tumor types using an appropriate population pharmacokinetic model.
OUTLINE: This is a multicenter study.
Patients receive BI 2536 IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Blood is collected periodically during study. Plasma samples are analyzed for pharmacokinetic studies by HPLC and tandem mass spectrometry.
After completion of study treatment, patients are followed every 3 months.
|Leuven, Belgium, B-3000|
|Study Chair:||Patrick Schoffski, MD, MPH||U.Z. Gasthuisberg|