metastatic soft tissue sarcomas, previously untreated
Conditions
Interventions
Product Name: palifosfamaide-tris
Product Code: ZIO-201-T, IPM-tris
Pharmaceutical Form: Lyophilisate for solution for infusion
INN or Proposed INN: Palifosfamide-tris
Current Sponsor code: ZIO-210-T
Sponsors
ZIOPHARM Oncology Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years. 2. Histological documentation of soft tissue sarcoma 3. Metastatic disease for which the patient has not received any prior treatment 4. Measurable disease as per RECIST 1.1. 5. ECOG Performance Status of 0,1or 2 6. Adequate bone marrow, liver, and renal function (defined in protocol) 7. Written informed consent 8. Highly reliable method of birth control from the screening visit through 28 days after the last dose of study drug. 9. Negative urine pregnancy test performed within 21 days of the first day of study drug dosing (as appropriate). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 212 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 212
Exclusion criteria
Exclusion criteria: 1. Has any one of the sarcoma histological subtypes listed as ineligible 2. Anticancer chemotherapy, anticancer immunotherapy, or any investigational drug therapy for the treatment of metastatic sarcoma, prior to or during the study. 3. Any prior anthracycline use. 4. Known allergy to any of the study drugs or their excipients. 5. Unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a patient and/or their compliance with the protocol. 6. Myocardial dysfunction defined as left ventricular ejection fraction (LVEF) <50%. 7. Presence of, or history of any illness or injury to the urinary tract (renal or post-renal) which may make the patient more susceptible to acute renal insufficiency in the case of potential renal adverse events. 8. Active infection requiring systemic antibacterial/antibiotic, antifungal, or antiviral therapy. 10. Any major surgery (e.g., requiring general anaesthesia) within 4 weeks prior to start of treatment. 11. Documented metastases to brain or meninges. 12. Any malignancy other than sarcoma within the last 5 years prior to screening, with protocol-defined exceptions 13. Currently pregnant or nursing. 14. Substance abuse or medical, psychological, or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results, in the opinion of the investigator. 15. Radiotherapy with curative intent within 4 weeks of first dose of study drug, however, palliative external beam radiation to bone lesions is permitted if started or planned prior to Cycle 1, Day 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess overall survival (OS) with an assessment of progression-free survival (PFS) as an accelerated approval endpoint. ;Secondary Objective: The secondary objectives are to assess quality of life (QoL), and safety and tolerability. ;Primary end point(s): The primary efficacy variable is overall survival, defined as the time from randomization to the date of documented death or date of last follow-up. There is also an assessment of progression free survival, defined as the time from randomization to the date of documented, objective PD, radiological or clinical findings or death (if prior to progression), as an accelerated approval endpoint. ;Timepoint(s) of evaluation of this end point: per protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): to assess quality of life (QoL), and safety and tolerability;Timepoint(s) of evaluation of this end point: per protocol | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Guatemala, India, Israel, Italy, Malaysia, Panama, Russian Federation, Singapore, Spain, United Kingdom, United States
Contacts
Public ContactSr VP Regulatory Affairs
ZIOPHARM Oncology Inc
Outcome results
None listed