Multi-center, open-label, non-randomised phase II study to evaluate the activity 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.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 148

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 21 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 <= 2.5*UNL)
- Adequate renal function (creatinine clearance > 50 ml/min, calculated or
measured; urine protein excretion <= 500 mg/24h
- PT/INR/PTT within 1.2 UNL
- LVEF above the lower limit of normal for the institution, based on ECHO
or MUGA; no class II, III or IV heart failure (NYHA classification); a patient who has a history of class II heart failure and is asymptomatic on treatment may be considered eligible; no arterial or venous thrombosis, myocardial infarction, unstable angina,
cardiac angioplasty or stenting within the last 3 months
- No uncontrolled or poorly controlled hypertension (SBP >= 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.
- 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 allowed)
- before patient registration, 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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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