Advanced and/or metastatic Soft Tissue Sarcoma
Conditions
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically or cytologically confirmed high or intermediate grade malignant soft tissue sarcoma; most malignant tumors of non organ origin, as well as skin and uterine leiomyosarcoma are included - Measurable disease (according to RECIST) - Relapsed of refractory disease incurable by surgery or radiotherapy - No more than one combination or two single agents chemotherapy regimen for advanced disease; (neo)adjuvant therapy is not counted towards this requirement - No history of leptomeningeal or brain metastases - At least 18 years of age - WHO performance status 0 or 1 - Adequate bone marrow function (ANC>1.5 10**9/l, PLA>100 10**9/l - Adequate hepatic function (bilirubin within normal range, SGOP/AST and SGPT/ALT 50 ml/min, calculated or measured; urine protein excretion = 150 mm Hg, DBP >=90 mm Hg). Initiation or adjustment of BP medications is permitted prior to study entry, provided that patient has 3 consecutive BP readings less than 150 / 90 mm Hg each separated by a minimum of 24 hrs. These readings need to be collected prior to registration in the study. - No therapeutic dose warfarin; low molecular weight heparin and prophylactic low dose warfarin are permitted. PT/PTT must meet the above criteria. - Able to swallow and retain oral medication - Women should not be pregnant (negative serum pregnancy test at entry) or lactating, and agree to use contraceptive methods (oral contraceptive are not permitted) - Before patient registration, written informed consent must be given. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The following tumor types are ineligible - Malignant glomus tumors - Embryonal rhabdomyosarcoma - Chondrosarcoma - Osteosarcoma - Ewing tumors / PNET - Gastro-intestinal stromal tumors - Malignant solitary fibrous tumors - Dermofibromatosis sarcoma protuberans - Inflammatory myofibroblastic sarcoma - Neuroblastoma - Malignant mesothelioma - Mixed mesodermal tumors of the uterus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal objective of the trial is to evaluate the therapeutic activity, safety and tolerability of GW786034 in patients with advanced and/or metastatic soft tissue sarcoma who have relapsed following standard therapies or for whom no standard therapy exists.; Primary end point(s): The primary end-point is the progression free survival, assessed 12 weeks after start of treatment. Progression will be defined according to the "RECIST" criteria. ; Secondary Objective: A secondary objective is to characterize the population pharmacokinetic parameters of GW786034 in patients with advanced or metastatic soft tissue sarcoma. A third objective is to investigate whether biomarkers of angiogenesis can predict response to therapy, and understand unexplained / unexpected variations in the safety, response and pharmacodynamic parameters that may be attributable to genetic variations. | — |
Countries
Belgium, Hungary, United Kingdom
Outcome results
None listed