Advanced or metastatic soft tissue sarcoma. MedDRA version: 8.1 Level: HLGT Classification code 10041299 Term: Soft tissue sarcomas
Conditions
Interventions
Product Name: Brostallicin
Product Code: PNU-166196A
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Brostallicin
CAS Number: 203258-60-0
Current Sponsor code: PNU-166196A
C
Sponsors
SYSTEMS MEDICINE, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically proven advanced and/or metastatic malignant soft tissue sarcoma of high or intermediate grade, and of one of the following histologies (WHO classification 2002): . Adipocytic (liposarcoma dedifferentiated, myxoid/round cell, pleomorphic, mixed-type, not otherwise specified) . Fibroblastic (adult fibrosarcoma, myxofibrosarcoma, sclerosing epithelioid fibrosarcoma) . So-called fibrohistiocytic (pleomorphic Malignant Fibrous Histiocytoma (MFH), giant cell “MFH”, inflammatory “MFH”) . Leiomyosarcoma . Malignant glomus tumors . Skeletal muscles (rhabdomyosarcoma, alveolar or pleomorphic) excluding embryonal rhabdomyosarcoma . Vascular (epithelioid haemangioendothelioma, angiosarcoma) . Uncertain differentiation (synovial, epithelioid, alveolar soft part, clear cell, desmoplastic small round cell, extra-renal rhabdoid, malignant mesenchymoma, perivascular epithelioid cell tumor (PEComa), intimal sarcoma) excluding chondrosarcoma, Ewing tumors / Primitive neuroectodermal tumor (PNET) . Malignant peripheral nerve sheath tumors . Malignant solitary fibrous tumors . Undifferentiated soft tissue sarcomas not otherwise specified . Other types of sarcoma (not listed as ineligible), if approved by the Study Coordinator (written or e-mail approval needed prior to registration) -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 2 weeks of registration. Local histopathological diagnosis will be accepted for entry into the study -Relapsed, refractory and/or metastatic disease incurable by surgery or radiotherapy - Presence of measurable disease (according to RECIST criteria) - No prior chemotherapy regimen for advanced or metastatic disease; (neo)adjuvant therapy is allowed - At least 60 years of age, or patients at least 18 years of age non suitable for intensive chemotherapy combination treatments - WHO performance status 0 or 1 - Absence of symptomatic or known CNS metastases - Adequate bone marrow function (ANC> 2 x 1000000000/l, PLA>100 x 1000000000/l) - Adequate hepatic function (bilirubin = 1.5 UNL , SGOT/AST = 2.5 UNL and SGPT/ALT = 2.5 UNL, Alk.phos = 2.5 UNL) - Adequate renal function: calculated or measured creatinine clearance = 60 ml/min (see Appendix C) - Clinically normal cardiac function (LVEF assessed by MUGA or ECHO), normal 12 lead ECG, and in the past 6 months no serious cardiac illness or medical condition including but not confined to: . History of documented congestive heart failure (CHF) . High-risk uncontrolled arrhythmias . Angina pectoris requiring antianginal medication . Clinically significant valvular heart disease . Evidence of transmural infarction on ECG . Poorly controlled hypertension (e.g. systolic >180mm Hg or diastolic greater than 100mm Hg) - No prior 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 > 3 years) - Women should either not be of childbearing potential (having had a hysterectomy, a bilateral oophorectomy or bilateral tubal ligation), or be post-menopausal with a total cessation of menses of >1 year, or not be pregnant (negative serum pregnancy test at entry); should not be lactating; should agree to use contraceptive methods
Exclusion criteria
Exclusion criteria: The following tumor types are ineligible: . Embryonal rhabdomyosarcoma . Chondrosarcoma . Osteosarcoma . Ewing tumors / PNET . Gastro-intestinal stromal tumors . Dermatofibrosarcoma protuberans . Inflammatory myofibroblastic sarcoma . Neuroblastoma . Malignant mesothelioma . Mixed mesodermal tumors of the uterus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the activity of Brostallicin measured as 6 months progression-free survival when used as first line chemotherapy in patients with advanced or metastatic soft tissue sarcoma.;Secondary Objective: To evaluate the activity of the compound on efficacy endpoints, such as objective response rate, duration of response, overall progression-free survival and overall survival. To evaluate the safety in the concerned population.;Primary end point(s): 6 months progression free survival: patients considered as CR, PR or NC according to RECIST at the 26 weeks evaluation will be considered as “successes”. | — |
Countries
Belgium, Germany, Netherlands, United Kingdom
Outcome results
None listed