BI 2536 in Treating Patients With Recurrent or Metastatic Solid Tumors (NCT00526149) | Clinical Trial Compass
CompletedPhase 2
BI 2536 in Treating Patients With Recurrent or Metastatic Solid Tumors
Belgium76 participantsStarted 2007-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
Tumor-specific criteria:
* Head and neck cancer:
* Histologically or cytologically proven squamous cell carcinoma of the head and neck (excluding nasopharyngeal primaries)
* Patients presenting with new non-irradiated lesions in pre-irradiated field as target lesions are eligible
* Recurrent or metastatic disease, no longer suitable for local therapy
* Prior use of chemotherapy/chemoradiotherapy/EGFR inhibitors for the treatment of the primary disease/nonmetastatic disease is allowed
* No prior chemotherapy for recurrent or metastatic disease
* Prior treatment with EGFR inhibitor for metastatic advanced disease is allowed
* Breast cancer
* Histologically proven recurrent or metastatic adenocarcinoma of the breast that failed prior taxane and anthracycline therapy
* Patient must have had a minimum of one line and a maximum of 2 lines of chemotherapy treatment given either as adjuvant treatment or for recurrence/metastatic disease
* Patients who do not qualify for Her-2-based therapy allowed
* Hormone receptor status not specified
* Ovarian cancer
* Histologically proven ovarian epithelial cancer
* Metastatic or inoperable locally advanced disease
* Patients either progressing under or relapsing within 6 months of completion of any line of platinum and taxane-based therapeutic regimen for advanced disease
* Soft tissue sarcoma
* Histologically proven advanced and/or metastatic malignant soft tissue sarcoma of high or…
What they're measuring
1
Confirmed objective response rate (complete and partial responses) as defined by RECIST
Trial details
NCT IDNCT00526149
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC