Phase II Study of GW786034 in Patients With Relapsed or Refractory Soft Tissue Sarcoma
- Histological evidence of high or intermediate grade malignant soft tissue sarcoma, or
cytological evidence in case of presence of multiple metastases. List of eligible and
ineligible tumours are included in the protocol.
- Formalin fixed paraffin embedded tumour blocks and representative H/E
(haematoxylin/eosin) slides must be available for histological central review.
Histological central review is not required before treatment start but is mandatory
within 3 months of registration. Local histopathological diagnosis will be accepted
for entry into the study.
- Presence of measurable disease (according to RECIST criteria).
- Relapsed or refractory disease incurable by surgery or radiotherapy.
- Evidence of objective progression within the last 6 months (RECIST) documented by
measurements of disease,
- Patients must either not be eligible for chemotherapy (for instance because of age,
or because of a biological condition, or because of patient-refusal) or must have
received no more than one combination or two single agents chemotherapy regimen for
advanced disease; (neo) adjuvant therapy is not counted towards this requirement.
- At least 18 years of age
- WHO performance status 0 or 1
- Adequate bone marrow function
- Adequate hepatic function
- Adequate renal function
- PT / PTT less than 1.2 x UNL.
- LVEF above the lower limit of normal for the institution, based on ECHO or MUGA
- Able to swallow and retain oral medication
- Women should not be of childbearing potential and agree to use contraceptive methods
(Oral contraceptives are not allowed).
- Absence of any serious and/or unstable pre-existing medical, psychiatric or other
condition (including lab abnormality) that could interfere with patient safety or
obtaining informed consent.
- Absence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule;
those conditions should be assessed with the patient before registration in the
- Written informed consent is given according to ICH/GCP, and national/local
regulations before patient registration/randomization.
- history of leptomeningeal or brain metastases
- history of malignancies other than sarcoma (except for basal cell or squamous cell
carcinoma of the skin, carcinoma in situ of the cervix or breast, or the patient has
been free of any other malignancies for greater than 3 years).
- 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
- Arterial or venous thrombosis, myocardial infarction, unstable angina, cardiac
angioplasty or stenting within the last 3 months
- Uncontrolled or poorly controlled hypertension. 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.
- Women of childbearing potential, who are pregnant (negative serum pregnancy test at
entry) or lactating.
- Therapeutic dose warfarin. Low molecular weight heparin and prophylactic low dose
warfarin are permitted. PT/INR and PPT must meet the above inclusion criteria.
- Concurrent therapy with any specifically prohibited medication or requirement for
using any of these medications during treatment with pazopanib
- Major surgery, hormonal therapy (other than replacement), chemotherapy or
radiotherapy, immunotherapy or other investigational agent within the last 28 days
and/or not recovered from prior therapy within the last 28 days. Use of
erythropoietin is considered supportive care and is permitted. The patient should
have recovered from prior surgery and have no open wounds.
- History of malabsorption syndrome, disease significantly affecting gastrointestinal
function or major resection of the stomach or small bowel that could affect
absorption, distribution, metabolism or excretion of study drugs. No unresolved bowel
obstruction or diarrhea.