Trials / Completed
CompletedNCT00526149
BI 2536 in Treating Patients With Recurrent or Metastatic Solid Tumors
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BI 2536 | |
| OTHER | high performance liquid chromatography | |
| OTHER | mass spectrometry | |
| OTHER | pharmacological study |
Timeline
- Start date
- 2007-07-01
- Primary completion
- 2008-09-01
- First posted
- 2007-09-10
- Last updated
- 2013-10-07
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT00526149. Inclusion in this directory is not an endorsement.