Unresectable or metastatic soft-tissue sarcoma MedDRA version: 9.1 Level: LLT Classification code 10039491 Term: Sarcoma
Conditions
Interventions
Product Name: palisfosfamide tris
Product Code: IPM-tris, ZIO-201-T
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: palifosfamide
CAS Number: 31645-39-3
Concentration unit: mg milligram
Sponsors
ZIOPHARM ONCOLOGY, INC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age ≥18 years 2. Histological or cytological documentation of sarcoma (excluding alveolar soft-part sarcoma, chondrosarcoma, dermatofibrosarcoma, Ewing sarcoma, GIST, Kaposi sarcoma, mixed mesodermal tumor, osteosarcoma, radiation induced sarcomas, and unresectable low grade liposarcoma) who have failed ≤2 prior regimens including adjuvant therapy, or ≤1 prior regimen for metastatic/unresectable disease, and for whom treatment with doxorubicin is considered medically acceptable. Prior treatment with IFOS is acceptable. 3. Have measurable disease as per RECIST criteria (Appendix 2) 4. ECOG Performance Status of 0 or 1 (Appendix 3) 5. Anthracyclin naïve 6. Life expectancy of ≥12 weeks 7. Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements conducted within 14 days prior to dosing: a. Hemoglobin ≥9.0 g/dL b. Absolute neutrophil count (ANC) ≥1,500/mm3 c. Platelet count ≥100,000/mm3 d. Total bilirubin ≤1.5×ULN (upper limit of normal) e. ALT and AST ≤2.5×ULN or 5×ULN with hepatic disease f. Partial thromboplastin [PT]-INR/activated partial thromboplastin time [PTT] =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Has any one of the following sarcoma sub types: alveolar soft-part sarcoma, chondrosarcoma, dermatofibrosarcoma, Ewing sarcoma, GIST, Kaposi sarcoma, mixed mesodermal tumor, osteosarcoma, radiation induced sarcomas, and unresectable low grade liposarcoma. 2. Clinically evident congestive heart failure >Class II of the New York Heart Association (NYHA) guidelines (Appendix 4) 3. Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia, or ventricular arrhythmias classified as Lown III, IV, or V (Appendix 4) 4. History and/or signs of active coronary artery disease/ischemia with or without angina pectoris 5. Serious myocardial dysfunction defined as scintigraphically (MUGA [multiple gated acquisition scan], myocardial scintigram) or ultrasound-determined absolute left ventricular ejection fraction (LVEF) 6 months from definitive therapy and has a negative imaging study within 4 weeks of study entry. In addition, the subject must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable, provided the dose is stable for 1 month prior to study start, and following screening radiographic studies). 11. Previous malignancy (except cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis, & T1] or other malignancies curatively treated >5 years prior to entry) 12. Pregnancy or lactation 13. Substance abuse or medical, psychological, or social conditions that may interfere with the subject?s participation in the study or evaluation of the study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the difference in progression-free survival (PFS) between subjects treated with palifosfamide tris plus doxorubicin versus doxorubicin alone.;Secondary Objective: The secondary efficacy objectives are to assess the following variables between subjects treated with palifosfamide tris plus doxorubicin versus doxorubicin alone: safety and tolerability, time to progression (TTP), overall response rate ([ORR] proportion of subjects with confirmed partial and complete responses) per RECIST (response evaluation criteria in solid tumors) guidelines (see Appendix 2, overall response duration and time to objective response;Primary end point(s): The primary efficacy variable (PFS) is defined as time from Day 1 (first dose of study drug) to the date of documented, objective PD, radiological or clinical findings (defined as an increase ECOG PS of >=3) whichever is earlier, or death (if prior to progresion) Subjects without PD or death occuring as of the time of analysis will be censored as of the lst date of disease evaluation, but all subjects will be followed for survival. | — |
Countries
Italy
Outcome results
None listed