BI 2536 in Treating Patients With Recurrent or Metastatic Solid Tumors
- Conditions
- Endometrial CancerHead and Neck CancerMelanoma (Skin)Breast CancerOvarian CancerSarcoma
- Registration Number
- NCT00526149
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Confirmed objective response rate (complete and partial responses) as defined by RECIST
- Secondary Outcome Measures
Name Time Method Overall progression-free survival Clinical benefit as assessed by RECIST Duration of response Safety as assessed by CTCAE version 3.0 Overall survival
Trial Locations
- Locations (1)
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium