BI 2536 in Treating Patients With Recurrent or Metastatic Solid Tumors
|ClinicalTrials.gov Identifier: NCT00526149|
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : October 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Endometrial Cancer Head and Neck Cancer Melanoma (Skin) Ovarian Cancer Sarcoma||Drug: BI 2536 Other: high performance liquid chromatography Other: mass spectrometry Other: pharmacological study||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||September 2008|
- Confirmed objective response rate (complete and partial responses) as defined by RECIST
- Clinical benefit as assessed by RECIST
- Duration of response
- Overall progression-free survival
- Overall survival
- Safety as assessed by CTCAE version 3.0
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526149
|Leuven, Belgium, B-3000|
|Study Chair:||Patrick Schoffski, MD, MPH||University Hospital, Gasthuisberg|