Relapsed or metastatic soft tissue sarcoma MedDRA version: 15.1 Level: HLGT Classification code 10041299 Term: Soft tissue sarcomas System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Votrient 400 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PAZOPANIB
CAS Number: 444731-52-6
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
Martin-Luther-Universität Halle-Wittenberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytological confirmed malignant soft tissue sarcoma including any subtypes except: o Chondrosarcoma o Osteosarcoma o Ewing tumors and primitive neuroectodermal tumors o Gastrointestinal stromal tumors o Dermofibromatosis sarcoma protuberans o Inflammatory myofibroblastic sarcoma o Malignant mesothelioma o Mixed mesodermal tumors of the uterus 2. Patient must have received at least one prior chemotherapy including either an antrazyclin or ifosfamide or both. 3. ECOG performance status 0-2 4. At least 18 years old 5. Life expectancy > 3 months 6. Patients with at least one measurable lesion according to RECIST criteria (v1.1) 7. Able to swallow and retain oral medication 8. Adequate organ function as defined in protocol 9. 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) 10.Signed, written informed consent, willingness to comply with the protocol Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 81 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: 1. Patient has received prior treatment with any anti angiogenic drug (including bevacizumab and tyrosine kinase inhibitors) 2. Active malignancy or any malignancy in the last 5 years prior to first dose of study drug other than STS. 3. History of clinical evidence of CNS metastases or leptomeningeal carcinomatosis (more information see protocol) 4. Clinically significant gastrointestinal disorders/ abnormalities (defined in protocol) 5. Poorly controlled hypertension (defined in protocol) 6. Prolongation of corrected QT interval (QTc) > 480msec 7. Clinically significant cardiovascular disease, for example Cerebrovascular accident, myocardial infarction (equal or lower than 6 months before treatment start), unstable angina, NYHA Class II CHF, arrhythmia requiring medication 8. Major surgery or trauma within 28 days or any non- healing wound, fracture or ulcer 9. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to Pazopanib or Gemcitabine 10. Presence of uncontrolled infection 11. Women who are pregnant or breast feeding 12. Treatment with any other cancer therapies within 14 days prior to the first dose of study drug (defined in protocol) 13. Evidence of active bleeding or bleeding diathesis 14. Hemoptysis in excess of 2.5 mL (or one half teaspoon) within 8 weeks of first dose of study drug. 15. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels 16. 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 17. History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months 18. Unable or unwilling to discontinue use of prohibited medications listed in the 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 19. Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall survival (OS) • Time to Progression (TTP) • Response Rate (CR+PR+SD) • Toxicity (CTCAE, version 4.0) • Quality of live (EORTC) ;Timepoint(s) of evaluation of this end point: In this trial, a “treatment period” will be defined as 21 days. Overall survival, Toxicity and Quality of life assessment will be performed on day 1 and day 8 of each cycle. After 6 weeks, accordingly after 2 admitted cycles, and before starting third cycle patients will have documentation of disease status (CT/MRI) to evaluate Response Rate and Time to Progression. CT or MRI will be repeated afterwards every 8 weeks until progression. After progression, patients will be followed every 3 months ± 28 days until death. The investigator will record disease status, toxicities, quality of life and patient survival. | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this phase II trial is to assess the efficacy and toxicity of pazopanib alone or pazopanib plus gemcitabine in patients with refractory or relapsed metastatic soft tissue sarcoma (STS).;Secondary Objective: Secondary objectives are safety and tolerability of the treatment as well as overall survival, time to progression, response rate and quality of life. ;Primary end point(s): Efficacy of the drugs shown by Progression Free Survival Rate at 12 weeks. The Progressive Free Survival Rate at 12 weeks will be determined by the proportion of patients being alive without progressive disease 12 weeks after randomization.;Timepoint(s) of evaluation of this end point: 12 weeks after randomization | — |
Countries
Germany
Contacts
Public ContactHans-Joachim Schmoll
Martin-Luther-Universität Halle-Wittenberg
Outcome results
None listed