patients with five different tumour entities will be included in the present trial: 1. squamous cell carinoma of the head and neck 2. breast cancer 3. ovarian cancer 4. soft tissue sarcoma 5. meanoma
Conditions
Interventions
Product Code: BI 2536
Pharmaceutical Form: Solution for infusion
Current Sponsor code: BI2536
Concentration unit: mg/ml milligram(s)/millilitre
Concentration number: 2-
Sponsors
SCS Boehringer Ingelheim Comm.V
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Measurable disease based on RECIST with target lesion of at least 20 mm (or 10 mm spiral CT scans) (unidimensionally measurable). Documented progressive disease based on RECIST and proven by imaging prior to study entry (i.e. progression should be documented by 2 imaging scans performed within the past 6 months prior to registration showing progression according to RECIST). Administration of any prior systemic treatment for the current malignancy must have been completed for at least 4 weeks before first treatment in this trial including treatment with chemotherapy, radiotherapy, immunotherapy, hormonal therapy and treatment with monoclonal antibodies or small molecule tyrosine kinase inhibitors and others. Age at least 18 years. ECOG PS 0-2. Adequate haematological functions: ANC = 1.5 x 109/L, platelets = 100 x 109/L and Haemoglobin = 9 mg/dl. Adequate renal function: serum creatinine inferior or equal to 175 µmol/L. Bilirubin inferior or equal to 1.5 times ULN. AST/ALT inferior or equal to 2.5 times ULN in absence of liver metastases and inferior or equal to 5 times UNL in case of liver metastases. All patients (male and female) must use effective contraception if of reproductive potential. (Effective contraception methods are implants, injectable, combined oral contraceptives, IUDs, sexual abstinence and vasectomised partners for female patients). Females must not be pregnant (pregnancy test) or lactating at screening. Before first trial specific procedures are undertaken, written informed consent must be obtained from the patient according to ICH/GCP, and national/local regulations. - Head and neck cancer Histologically or cytologically proven squamous cell carcinoma of the head and neck (excluding nasopharyngeal primaries). Patient 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/chemo radiotherapy/EGFR inhibitors for the treatment of the primary disease/non metastatic 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 which 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. - Ovarian cancer Histologically proven epithelial ovarian 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 intermediate grade and one of the histologies defined by the WHO classification 2002: leiomyosarcoma, adipocytic sarcoma, synovial sarcoma and others (further described in chapter 3.2.4) but which exclude embryonic rhabdomyosarcoma, chondrosarcoma, osteosarcoma, Ewing tumours/PNET, GIST, dermatofibrosarcoma protuberans, inflammatory myofibroblastic sarcoma, neuroblastoma, malignant mesothelioma, mixed mesodermal tumours of the uterus. Patients must have received no more than one combination or two single agents of chemothe
Exclusion criteria
Exclusion criteria: clinical evidence of brain metastases. presence of any psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule; such conditions should be assessed with the patient before registration in the trial. other previous and active malignancy for at least 5 years with the exception of cone biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma. persistence of toxicities from prior anti-cancer therapy deemed clinically relevant. concomitant intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would limit compliance with trial requirement or which are considered relevant for the evaluation of the efficacy or safety of the trial drug. treatment with any other investigational drug within the past four weeks or within less than four half-life times of the investigational drug before treatment with the trial drug (whatever is the longest period). major surgery within 4 weeks prior to the first treatment with the trial drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: confirmed response rate as defined by RECIST;Secondary Objective: clinical benefit defined as the rate of responders and stable patients (RECIST) duration of response in responding patients overall progression free survival overall survival safety profile according to CTCAE Version 3 plasma concentration time course by using an appropriate population pharmacokinetic model;Primary end point(s): confirmed response rate (RECIST) | — |
Countries
Belgium, France, Germany, Netherlands, United Kingdom
Outcome results
None listed