Phase II randomized clinical trial of Pazopanib alone and Pazopanib plus Gemcitabine in relapsed or metastatic soft tissue sarcoma

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 90

Inclusion Criteria

•Histologically confirmed malignant soft tissue sarcoma (relapsed or metastatic) including any subtypes except:
oChondrosarcoma
oOsteosarcoma
oEwing tumors and primitive neuroectodermal tumors
oGastrointestinal stromal tumors
oDermofibromatosis sarcoma protuberans
oInflammatory myofibroblastic sarcoma
oMalignant mesothelioma
oMixed mesodermal tumors of the uterus
•Relapse or progress after one or two prior chemotherapies including either an antrazyclin or ifosfamid or both. Patients with relapse or progress with liposarcoma or leiomyosarcoma must be offered a treatment with Trabectedin. •Pretreatment with trabectedine is permitted
•ECOG performance status 0-2
•At least 18 years old
•Life expectancy > 3 months
•Patients with at least one measurable lesion according to RECIST criteria (v1.1)
•Able to swallow and retain oral medication
•Adequate organ function as defined in protocol
•A female is eligible to enter and participate in this study if she is either of non childbearing potential (defined in protocol) or childbearing potential with negativ pregnancy test within 2 weeks prior to the first dose of study and agrees to use adequate contraception (as defined in protocol)•Male with childbearing potential agree to use adequate contraception
•Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up. Procedures conducted as part of the subject’s routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.

Exclusion Criteria

•Patient has received prior treatment with any anti angiogenic drug (including bevacizumab and tyrosine kinase inhibitors)
•Active malignancy or any malignancy in the last 5 years prior to first dose of study drug other than STS.
•History of clinical evidence of CNS metastases or leptomeningeal carcinomatosis (more information see protocol)
•Clinically significant gastrointestinal disorders/ abnormalities (defined in protocol)
•Poorly controlled hypertension (defined in protocol)
•Prolongation of corrected QT interval (QTc) > 480msec
•Clinically significant cardiovascular disease, for example Cerebrovascular accident, myocardial infarction (< 6 months before treatment start), unstable angina, NYHA Class II CHF, arrhythmia requiring medication
•Major surgery or trauma within 28 days or any non- healing wound, fracture or ulcer
•Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to Pazopanib or Gemcitabine
•Presence of uncontrolled infection
•Women who are pregnant or breast feeding
•Chemotherapy or radiotherapy within 14 days prior to the first dose of study drug (defined in protocol)
•Evidence of active bleeding or bleeding diathesis
•Hemoptysis in excess of 2.5 mL (or one half teaspoon) within 8 weeks of first dose of study drug.
•Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
•Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures
•History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
•Unable or unwilling to discontinue use of prohibited medications as defined in protocol for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study
•Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.
•Existing medication with prohibited and interactional drugs with the study drug must be asked in detail. Indispensable use of long term medication with CYP-inhibitors or inductors, explicitly (changes in long term medication is possible; defined in protocol) is prohibited.
•Insufficient liver function (defined in protocol)
•Autoimmune disease
•Uncontrolled hypothyroidism

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials